Search Results Within Category "Neurology"
A multisensory evoked potential brain-computer interface for communication in ALS
A brain-computer interface (BCI) is a device that has the potential to restore communication by direct translation of brain signals. The BCI used in this study, the P300 Speller, relies on the generation of a P300 evoked potential when a user is presented a rare and unpredictable target stimulus amidst a larger pool of non-target stimuli. This evoked potential is used to perform selections on the computer. Those with advanced ALS demonstrate decreased capacity for BCI control using the P300 speller. With this study, we aim to use a combination of eye tracking and sensory testing to quantify sensory and cognitive processes necessary for the generation of a P300 response. We will test the performance of a multisensory P300 spelling task, where brain potentials are evoked using a combination of visual, auditory, and tactile stimuli. The goal is to demonstrate the perceptual benefits of multisensory integration and generate evidence for its use in this patient group.
A brain-computer interface (BCI) is a device that has the potential to restore communication by direct translation of brain signals. The BCI used in this study, the P300 Speller, relies on the generation of a P300 evoked potential when a user is presented a rare and unpredictable target stimulus amidst a larger pool of non-target stimuli. This evoked potential is used to perform selections on the computer. With this study, we aim to use a combination of eye tracking and sensory testing to quantify sensory and cognitive processes necessary for the generation of a P300 response. We will test the performance of a multisensory P300 spelling task, where brain potentials are evoked using a combination of visual, auditory, and tactile stimuli.
$40
Fluent in written and spoken English.
Able to visit the study site in-person for the study visits
(Patient Group Only) - Diagnosis of motor neuron disease, including ALS.
(Control Group Only) Neurologically healthy individuals matching the age, gender, and education level of the patient cohort.
History of seizure disorder
Co-existing neurological or psychiatric illness that, in the opinion of the research team, exclude the subject from participation.
Neurobehavioral mechanisms of social and non-social risky decision making.
The purpose of this study is to understand the neural and behavioral mechanisms subserving social and non-social risky decision making.
There will be two in-person lab visits. In the first (half hour) lab visit, you will play a decision-making game while having a mock scan. In the second (two hour) lab visit, you will play a decision-making game while having an fMRI scan.
$38.00
Able to read and speak English
Normal to corrected vision in order to see a computer screen clearly
No history of head injury
No MRI contraindications
History of head injury
Had an event where loss of consciousness > 10 minutes
Weighs more than 300 pounds
Does not read and speak English
ALL ALS-ASSESS
This study will follow symptomatic ALS participants and control participants for 2 years, measuring a wide range of ALS outcome measures and gathering long term survival data.
Study visits will be conducted both in an in-clinic setting (on-site) and remotely (off-site) over the course of 24 months (2 years). The symptomatic ALS cohort participants can either participate in on-site or off-site visits, depending on their location and ease of access to one of the participating sites. During this 2-year period, symptomatic ALS participants will complete a screening visit (2-3 hours to complete), a total of 7 in-person study visits (1-3 hours to complete) and 24 remote self-assessment activities (completed each month, takes 35-45 minutes to complete). Participants and will need access to a personal device (i.e. a computer and/or smartphone or tablet) and an internet connection to participate in this study. All control participants will participate on-site, completing their on-site visits every 12 months. Biospecimens will be collected at regular intervals to support biofluid biomarker analyses. Biospecimens will include plasma, serum, whole blood for generation of induced pluripotent stem cells (iPSCs) and DNA for whole genome sequencing, and cerebrospinal fluid (CSF). For on-site symptomatic ALS and control participants, CSF will be collected through optional Lumbar Puncture (LP) procedure. Only plasma, serum and whole blood will be collected for off-site participants through home phlebotomy collection process.
Up to $350
Capable of providing informed consent
Willing to follow study procedures
Diagnosis of ALS by a physician
Access to a smartphone, computer or tablet, and internet (need not be in the home – access to a public library or other available computer with internet connection is sufficient)
Clinically significant unstable medical condition (other than ALS) that would render the participant unlikely to be able to complete 12 months of follow-up, according to Investigator’s judgment.
Optional Lumbar Puncture - Medically unable to undergo LP; allergy to Lidocaine or other local anesthetic agents; use of anticoagulant medication or antiplatelet medications (aside from aspirin 81mg) that cannot be safely withheld prior to LP.
Rapid Motor Regulation Mechanism for Arm Movement in Response to Visual Motion
This study looks at the relationship between motor control via. arm movement and visual stimuli. After participating in brief calibration protocol for the eye tracking system, participants will be moving a robotic handle to interact with visual stimuli during various tasks. Participants will spend approximately 2 hours in the lab.
There will be one approximately 2-hour visit. They will then be asked to complete 20-25 blocks of hand movements while looking at a moving virtual stimulus with a large visual background. Participants will receive regular breaks during the experiment.
$20
Right-hand dominant
Normal or corrected-to-normal vision
Able to sit upright in a chair for long periods
Able to grasp and move objects with both hands
Any history of musculoskeletal disorders
Eye or vision problems (e.g., cataracts, glaucoma, a detached retina or macular degeneration)
Cognitive impairment such that informed consent cannot be obtained, or that participant would not be safe with the protocol
Medication that could make the participant drowsy or tired during the experiment
Defining the role of slow eye movements on limb motor control in younger and older adults
The purpose of this study is to define how eye movements contribute to eye-hand coordination in individuals of the age group 18-50 (young adults) and 65-80 (older adults). Specifically, the aim of the study is to understand how slow eye movements affect arm and hand movements. All procedures to be used in our study will be non-invasive. The task during the study will be performed with a robotic handle that participants will grasp with their right hand. They will interact with visual stimuli by moving the robotic handle. The robotic environment will attempt to simulate real-world mechanical interactions, such as those experienced during catching a ball.
During this study, we will ask you to come to our laboratory located in 23 Recreation Building, Pennsylvania State University, on two days separated by a maximum of 48 hours. Both sessions will last approximately 90-120 minutes. During the first session, we will review the procedures with you and if you agree to participate, you will sign this form and then proceed to perform the study. You will perform about 20-25 blocks of hand movements. Each block will consist of 24-30 trials and each trial will last between 3-5 seconds.The second day will be identical to the first day but the order of trials within a block will be changed.
$10/hour
Participants will be right-hand dominant individuals.
They will have normal or corrected-to-normal vision.
Participants should be able to sit upright in a chair for long periods (up to 2 and a half hours) with rest.
Participants should be able to grasp and move objects with both hands.
Any history of musculoskeletal disorders
Eye or vision problems (e.g., cataracts, glaucoma, a detached retina or macular degeneration).
Cognitive impairment
Medication that could make the participant drowsy or tired during the experiment.
The Ecology of Infant Emotion-Regulation
This study aims to understand how emotion regulation in infants develops within the context of family and community support. We're particularly interested in the relation between mother-infant synchrony, facilitated by family and community support, and infant emotion regulation. We will use a multi-method approach to collect simultaneous brain activation in mothers and infants, infant's physiological responses, and information about family and community support.
Participants complete an online survey, then come in for 1 in-person visit. This research aims to find out how patterns of brain activation in infants and mothers and infant physiological responses relate to the real life, face-to-face interactions that mothers and babies usually engage in.
50
Infants born 3 weeks within their due date.
Infants of a birth weight > 2500 g.
Infants with NO serious medical complications.
English-speaking families.
Infants who experienced any serious medical complications.
Infants who were born > 3 weeks before the indicated gestational period.
Families who do not understand and do not speak English
Eye-hand coordination during upright stance
The study will determine how the brain controls eye and hand movements during quiet upright stance.
There will be one visit to the lab (approximately 2 hours) in which participants will be required to make reaching movements towards virtual targets while standing upright. Participants will be required to wear comfortable shoes.
$20
3) Participants will be right-hand dominant individuals
4) They will have normal or corrected-to-normal vision
5) Participants should be able to stand upright for long periods (up to 2 and a half hours) with rest every 5-10 minutes or as requested by the participant
6) Participants should be able to grasp a handle and move objects with both hands
Any history of musculoskeletal disorders (e.g., carpal tunnel syndrome)
Any history of cardiovascular disease (e.g., Coronary Artery disease, Peripheral Artery disease, Carotid Artery disease, Hypertension, Congenital Heart disease, Congestive Heart failure, Myocardial Infarction, Cardiac Arrythmias, Stroke).
Any history of conditions or diseases that increase risk for syncope (e.g., Anemia, Myocardial Ischemia, Kidney disease).
Any history of conditions or diseases of the vestibular system
Multimodal brain MRI-guided understanding of non-motor outcomes in Parkinson's post DBS
This study will explore the relationship between multimodal brain MRI findings and cognitive/mood outcomes in Parkinson's Disease (PD) patients following Deep Brain Stimulation (DBS). Patients already planning to undergo DBS for PD who choose to take part in this study will have study visits before and after DBS to collect motor, neurobehavioral and physical therapy measurements.
Patients who are already planning to undergo DBS for PD who choose to take part in this study will have study visits before and after DBS surgery to collect motor, neurobehavioral and physical therapy measurements. While many of these components are part of as standard of care, some assessments will need to be collected specifically for research purposes. There are two in-person visits (one before DBS surgery and one approximately 3-6 months after surgery). As part of the study, an MRI to gather data to answer our research questions will be conducted. This is in addition to the clinical MRI that is part of the regular assessment to determine if an individual is suitable for the DBS surgery.
$130 if components of study are completed
Diagnosed with Parkinson's Disease
Undergoing DBS as part of standard of care
Able to provide informed consent
General contraindications to surgery
Pregnant or nursing women
Unable to undergo MRI for any reason
Atypical Parkinsonism
Assessment of nocturnal hypoventilation in amyotrophic lateral sclerosis
The overall goals of this study are to identify how measurement of carbon dioxide during sleep can improve recognition of respiratory distress in neuromuscular disease and thus improve timely access to respiratory therapies which prolong survival. Subjects in this study will participate for up to one year, during which their carbon dioxide levels will be measured in clinic and in their homes during sleep.
Subjects in this study will participate for up to one year, during which their carbon dioxide levels will be measured using deviced attached to the skin while in clinic and in their homes during sleep. Subjects will also complete surveys at the time of clinic visits.
50
18 years of age or older.
Plan to be followed up in person in the Hershey ALS Clinic for the next 12 months.
Experiencing early respiratory change.
Able to perform or have assistance performing home CO2 measurements.
Use of any type of non-invasive ventilation, except in the case of CPAP for obstructive sleep apnea, or have a tracheostomy
Use of diaphragm pacer
Pre-existing pulmonary disease requiring supplemental oxygen for any portion of the day or night
Interlimb differences in Motor Control and Learning
This study examines how each brain hemisphere contributes to motor control and coordination. Participants play virtual reality/computer games to look at how their arms move during different activities.
Participants play 2D virtual reality/computer games by making reaching movements with position tracking sensors attached to their hands and upper arms.
15
upper-extremity orthopedic injuries that interfere with participation
Abstract Reasoning, Decision Making and Social Judgment as Markers of Frontotemporal Lobar Degeneration (FTLD) in Midlife in Juvenile Myoclonic Epilepsy (JME)
This study will look for emerging patterns of Frontotemporal Lobar Degeneration (FTLD), an early onset dementia, in Juvenile Myoclonic Epilepsy (JME). JME is a type of epilepsy that usually begins in adolescence and is known to be associated with disturbances of higher-level reasoning, mood and personality. JME patients are often managed by family physicians, rather than epilepsy specialists; with little known about aging with JME. We think that JME patients will demonstrate a pattern of executive dysfunction that is consistent with consensus criteria for FTLD, characterized by declines in abstract reasoning, judgment, and verbal problem solving, as well as behavior. We also think that there will be an inverse relationship between apathy and conscientiousness. We plan to obtain this information by formal cognitive testing of non-demented JME patients over a period of 2 years, at 6-month intervals, to look for progression of symptoms. Loved ones/caregivers will complete informant questionnaires about patient's mood and personality at the beginning of the study and at 6 month intervals throughout the duration of the 24 month study. We will also include loved one/caregiver cognitive testing at the beginning of the study to obtain healthy information for comparison to patient's findings. Our objectives are to characterize the executive functioning profiles of JME in midlife, taking into account cognition, mood, personality, nutritional status and lifestyle. The information obtained may contribute to better care of JME patients prior to midlife and throughout the course of aging.
Visit 1 for both patient and healthy caregiver participants will involve administration of the JME Virtual Visit Protocol via PSH Zoom. Participants will have completed their REDCap questionnaires prior to the visit to the research coordinator, who will be conducting the assessment. Visit 2-5 for patient participants will involve administration of the JME Virtual Visit Protocol via PSH Zoom. JME participation consists of 5 virtual visits with the study’s research coordinator, lasting approximately two hours each, for completion of standardized tests of problem-solving, thinking, and concentration, as defined above. Caregiver healthy control participation consists of 1 virtual visit with the study’s research coordinator, lasting approximately two hours, for completion of standardized tests of problem-solving, thinking, and concentration, as defined above. Remaining participation involves completion of objective inventories providing a caregiver perspective of the patient participant’s mood and behavior at 6-month intervals, within the 24 month time frame of the study.
Primary language English
age 35 - 65
Mainstream Education
Loved one or caregiver to complete questionnaires
Cardiac conditions affecting cognition
Other medical conditions affecting cognition,e.g.,hypoglycemia
Hospitalization for major depressive disorder within the past year
No available loved one or caregiver to complete questionnaires
Atrophy of Olfactory Bulb in Early-stage Parkinson’s disease
This research is being done to study the deterioration of the central olfactory system (sense of smell system) in the brains of patients diagnosed with early- stage Parkinson’s disease.
Patients should not have reached their 65th birthday.
Patients that have tremor, rigidity, and bradykinesia unilaterally
Autonomic dysfunction
Parkinson-plus syndrome
Postural instability
History of exposure to substances that cause parkinsonism
The role of ocular and limb motor inhibition for dexterous motor control
In this project, participants will perform experiments where they will be asked to look at salient virtual targets and make reaching movements to those targets, while ignoring other visual stimuli presented to them.
During this study, we will ask you to come to our laboratory located in 23 Recreation Building, Penn State University, on a single day.We will ask you to perform an eye-hand coordination task using a robot. You will sit in a modified chair and grasp a handle that permits you to move your hand leftward, rightward, towards and away from your body. A display system will project visual targets into the same plane as your hands, which will allow you to interact virtually with the visual targets. These targets will be either bright or dark and you will be instructed to look at some of these targets (while ignoring others) and make reaching movements to some of these targets.
20
Male and female participants who volunteer for the study and provide informed consent.
Participants will be right-hand dominant individuals.
They will have normal or corrected-to-normal vision.
Participants should be able to sit upright in a chair for long periods (up to 2 and a half hours) with rest.
Any history of musculoskeletal disorders
Eye or vision problem
Cognitive impairment such that informed consent cannot be obtained, or that participant would not be safe with the protocol.
Medication that could make the participant drowsy or tired during the experiment
Digital tools for assessment of motor functions and falls in ALS
This is a 48-week, two arm study that incorporates digital tools for assessing motor function in amyotrophic lateral sclerosis (ALS) and healthy controls. During the study, neck- and wrist-worn “activity sensors” (PAMSys, BioSensics, Newton, MA) will be worn by subjects while performing tasks of daily living. Subjects will also complete a motor, speech, and handwriting assessment during site visits. They will complete a digital home assessments of speech, handwriting, and pattern tracing tasks throughout the study, and report any falls which occur on the study tablet. We will explore whether sensor-based functional changes are sensitive to self-reported changes over the length of the study.
During the study, neck- and wrist-worn “activity sensors” (PAMSys, BioSensics, Newton, MA) will be worn by subjects while performing tasks of daily living. Subjects will also complete a motor, speech, and handwriting assessment during site visits. They will complete a digital home assessments of speech, handwriting, and pattern tracing tasks throughout the study, and report any falls which occur on the study tablet. Subjects will be required to visit the study site around the time of 5 consecutive standard ALS clinic appointments.The research study will last approximately 48 weeks.
$240
18 years of age or older
Walking with or without mobility support (such as a cane or walker)
Fluent in written and spoken English
Pregnant or nursing woman
Prisoner or institutionalized individuals
Have any clinically relevant medical history of other disease or diseases that, in the opinion of the research team, exclude the subject from participation (including severe cognitive dysfunction).
Environmental Exposure and ALS
We are hoping to learn more about the relationship between environmental exposures and developing ALS (Amyotrophic lateral sclerosis - Lou Gehrig’s Disease). Our focus will be on heavy metal and other potential exposures that might occur throughout life at home, in the workplace, and during military service, as examples. Study participants will attend a single study visit to provide information about environmental exposure and to donate blood and toenail clippings.
- Attend a single study visit lasting 1-2 hours - Informed consent - Complete environmental exposure questionnaire - Blood sample collection - Collection of toenail clippings
$20
ALS diagnosis (for cases)
Cognitive ability to consent or legally authorized represenative
Digital assessment of speech and fine motor control in motor neuron disease
This study includes collection of digital speech and fine motor control assessment data at a single study visit. Features extracted from this data will be compared with standard clinical disease outcome measures and also the features derived from control participant data. We will use these comparisons to explore the use of these digital assessments in capturing the range of functional changes that occur in motor neuron disease.
This is a single-session study that measures speech and fine motor function using digital tablet-based assessments. Patients with motor neuron disease and age-matched healthy controls will be enrolled. Sessions take approximately one hour.
$20
[Patient Group Only] at least minimal speech or handwriting ability
[Control Group Only] Possess no neurological or orthopedic problems that affects their speech or handwriting AND age- and sex-matched to the existing patient cohort
18 years of age or older
Fluent in written and spoken English.
Pregnant or nursing woman
Prisoner or institutionalized individuals
Have any clinically relevant medical history of other disease or diseases that, in the opinion of the research team, exclude the subject from participation (including severe cognitive dysfunction).
Application of graph theory to both resting-state and task-based fMRI data to uncover brain-behavior relationships related to therapy outcomes in aphasia
This project will use fMRI to examine changes in the brain related to behavioral therapy outcomes in persons with aphasia. We aim to recruit twenty persons with aphasia. Each participant will receive 4 MRI scans. Between scan 1 and scan 2, no therapy will be provided (10 week break). Between scan 2 and scan 3, ten weeks of word finding therapy will be provided. Between scan 3 and scan 4, no therapy will be provided (10 week break). The therapy used is abstract word retrieval training. The results of this project will help inform rehabilitation practices in aphasia.
There will be 4 fMRI scans. After the first and third fMRI scans, there will be an assessment. After the second fMRI scan, there will be 10 weeks of treatment.
$460
Sustained stroke at least 6 months ago
Right-handed
Native English speaker
Completed at least a high school education
History of other acquired neurological disorder (e.g., TBI)
History of developmental disorder (e.g., autism)
History of psychological disorder (e.g., schizophrenia)
Unsafe to receive MRI (e.g., pacemaker)
Asymmetric neurodegeneration of central olfactory system in early-stage Parkinson’s disease
This research is being done to study the deterioration of the central olfactory system (sense of smell system) in the brains of patients diagnosed with H&Y stage 1 or 2 Parkinson’s disease compared to that of healthy volunteers.
In this study, you will receive a clinical evaluation and an MRI examination. After that, you will be followed every 12 months for up to 4 years.
up to a total of $250.00.
Cognitively-normal H&Y stage 2 PD patients. H&Y stage 2, as defined by an exam in the practically defined “off” state, and have a diagnosis of PD at the age of 59 or younger. 1st visit prior to age 68
Healthy participants between ages 40-67 at their first visit.
Able and willing to provide informed consent
Fluent in written and spoken English
Dementia
Previous antipsychotic or anti-dopamine drug therapy
Traumatic head injury
Other neurological diseases or disorders
Vivistim Registry for Paired VNS Therapy (GRASP)
The purpose of the Vivistim Registry for Paired VNS Therapy (GRASP) is to gather real-world information on patients with arm and hand deficits post- stroke who are considering Vivistim System treatment. Before and after Vivistim System implant, patient data will be collected and reported throughout the therapy process.
The purpose of this study is to follow individuals that plan to be implanted with the MicroTransponder Vivistim® System. We will be collecting data at various time points over 3 years. Data collection includes questionnaires about arm movement, quality of life, productivity, and use of healthcare services. This study lasts for 3 years, with 6 total visits. One visit is prior to being implanted and 5 are post-implant. Visits can be done via telephone or in person. Questionnaires and Therapy data will be collected at each visit.
$600.00
You have suffered a stroke
You have moderate to severe upper limb deficits
You plan to be implanted with the MicroTransponder Vivistim® System.
You do not have upper limb deficits.
You are currently enrolled in an investigational study.
You have previously been implanted with a Vivistim® System.
Neural Correlates of Cognitive Dysfunction in Postural Tachycardia Syndrome
Postural tachycardia syndrome (POTS) is a chronic syndrome in which the heart beats too quickly when standing. POTS primarily affects young women. People with POTS also experience symptoms such as feeling faint, fatigue, nausea, and mental clouding or "brain fog." “Brain fog” is one of the most bothersome symptoms of POTS and it is unknown why people with POTS experience this symptom. Some studies have shown that POTS patients have problems with attention, memory and executive function (ability to plan, organize information, and adapt to changes) while seated and when upright. In this study, we will evaluate how brain function during mental tasks is affected in people with POTS compared to healthy volunteers. All volunteers will complete mental tasks while lying down and standing. If eligible, we will measure brain activity using functional magnetic resonance imaging (fMRI).The findings from this study will increase our understanding of the mental complaints in people with POTS, to hopefully help with development of new treatments.
There will be three in person visits for this study. At the screening visit, participants will undergo a detailed medical history and physical examination and then will complete a mental test while lying down and standing. If eligible based on the results of the mental test, participants will undergo a pregnancy test if female and of childbearing potential, measurements of blood pressure and heart rate and blood draws while lying down and standing up, and a test to determine if they can tolerate being in a lower body negative pressure (LBNP) device that distributes more blood to the legs to mimic standing. If eligible based on the results of the screening visit, participants will be asked to complete an online questionnaire and two study visits that are separated by at least one week. At these study visits, they will perform a mental test in a magnetic resonance imaging (MRI) scanner. The LBNP device will also be used while in the MRI scanner to distribute more blood to the legs to mimic standing.
$25 per hour; additional $25 for completion of online questionnaire
18- 60 years old
Previously Diagnosed with POTS or healthy people without chronic illness
Capable of giving informed consent
Pregnant or breastfeeding women
Other potential causes for tachycardia (e.g. prolonged bed rest, dehydration)
Taking stimulant medications within the past 3 months as these may alter cognition
Unable to tolerate an MRI scanner (e.g. claustrophobia, implanted metal)
brain-computer interface in the epilepsy monitoring unit
Patients who are undergoing monitoring with scalp or intracortical EEG can be followed in the epilepsy monitoring unit for more than a week. This clinical resource provides an opportunity to conduct a comparison of imagery-based brain-computer interface control between scalp and intracranial recordings. The outcomes will be the information density of the signal of intent using the two recording methods, as well as the accuracy in controlling a single- and multi-dimensional computer task. A control group of neurologically-healthy control participants will be compared.
There will be two in-person visits lasting one hour each. Participants will complete a set of questionnaires and have an electroencephalography (EEG) recording performed while completing computer tasks.
$40
No history of neurological disorders
Age 18 years or older
Non-English Speakers. The questionnaires and instructions for imagery are available in English only.
NSF Proposal 2000047: Understanding the contribution of individual differences to domain-general and domain-specific components of false memories in both young and older adults
This research study investigates the neural processes underlying how people process, store, and remember visual or auditory information.
Participants ages 18-30 will participate for one 2-hour session involving 1 hour inside the MRI scanner. Participants ages 60-85 will participate for five sessions total, two of them being MRI scans. All five sessions will occur between 7-10 days of each other and scheduling is very flexible.
$15.00/hour for behavioral tasks, $20.00/hour for fMRI scanner tasks.
Ages 60-85
High school education
Learning disability
Stroke, TIA, or severe brain injury
Unsafe metal implanted in body
Infection threat and social decision-making using fMRI
The purpose of this study is to test how social decisions are affected by possible risk of infection. We aim to examine the neural and behavioral mechanisms underlying how choices in a risky social decision-making situation can be influenced by viewing images of infection threat (e.g., person with runny nose) vs. images of neutral scenes or other threatening scenes.
Participants will come to the research site for a one-time visit. They will complete brief questionnaires, followed by playing a social decision-making game while undergoing fMRI scanning.
$35.42
English speaking
Does not suffer from claustrophobia
Does not have contraindications to MRI scanning
Does not weigh more than 300 pounds
Cannot speak English
Suffers from claustrophobia
Has contraindications to MRI scanning
Weighs more than 300 pounds
HEALEY ALS Platform Trial - Master Protocol
The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. The trial is designed as a perpetual platform trial. This means that there is a single Master Protocol dictating the conduct of the trial. The Master Protocol describes the overall framework of the platform trial, including the target population, inclusion and exclusion criteria, randomization scheme, study endpoints, schedule of assessments, trial design, the mechanism for adding and removing interventions, and the statistical methodology and recommended statistical methods for evaluating interventions.
The HEALEY ALS Platform Trial is a research trial that tests the safety and effectiveness of multiple treatments in ALS. A regimen is a specific course of treatment, each with a different study drug. The following things will happen in this research study: Blood and urine sample collection; Completion of questionnaires; Physical and neurological exams; Vital signs, current and historical review of medical information about general health and medication use review; Muscle strength testing; Measurement of the electrical activity of the heart with an electrocardiogram (ECG); and Measurement of respiratory (breathing) function. Participants will also take either the study drug, or placebo, according to the study schedule
Slow vital capacity (SVC) at least 50% predicted
Time since onset of weakness due to ALS within 36 months
Able to swallow pills and liquids
Clinically significant unstable medical condition (other than ALS) that would pose a risk to you
Memory and Aging Study
This research is being done to find out more about changes in the brain as we age and to determine if MRI, genetic (DNA) variations, and neuropsychological tests can be used to evaluate memory loss and cognitive impairment.
Diagnosis of Mild Cognitive Impariment
Normal Controls-Cognitively normal functioning
Psychiatric disorder (e.g., bi-polar, schizophrenia, etc.)
History of chemotherapy
Presence of a cold or viral infection
Presence of a pacemaker, aneurysm clips, or any metal in body
Remote testing for psychophysical studies of sensory perception and cognition
The purpose of this study is (1) to understand how the brain processes sensory information and (2) how this is affected by factors like blindness or synesthesia.
Participants will complete simple online tasks, for example judging differences in auditory pitch; processing visual and auditory stimuli in congruent and incongruent pairings; rating the sound-symbolic properties of either real words, pseudowords, or both; or discriminating between two stimuli on the basis of their structural properties over a change in their surface properties, and vice versa.
Amount varies depending on the study
Normal or corrected-to-normal vision
No other sensory deficits
Adults who experience synesthesia
Defining the role of slow eye movements on limb motor control
The purpose of this study is to define how eye movements contribute to eye-hand coordination. All procedures to be used in our study will be non-invasive. The task during the study will be performed with a robotic handle that participants will grasp with their right hand. They will interact with visual stimuli by moving the robotic handle. The robotic environment will attempt to simulate real-world mechanical interactions, such as those experienced during catching a ball. Our objective is to understand how the nervous system processes visual sensory information of moving objects through slow eye movements called smooth pursuit eye movements.
During this study, we will ask you to come to our laboratory located in 23 Recreation Building, Penn State University, on two days separated by a maximum of 48 hours. Both sessions will last approximately 90-120 minutes.We will ask you to perform an eye-hand coordination task using a robot. You will sit in a modified chair and grasp a handle that permits you to move your hand leftward, rightward, towards and away from your body. A display system will project visual targets into the same plane as your hands, which will allow you to interact virtually with the visual targets. These targets will move in the workspace. When the target comes in contact with your arm, the robot will apply a gentle force to mimic what you would typically experience when you catch a ball.
40
Male and female participants who volunteer for the study and provide informed consent.
Participants will be right-hand dominant individuals.
They will have normal or corrected-to-normal vision.
Participants should be able to sit upright in a chair for long periods (up to 2 and a half hours) with rest.
Any history of musculoskeletal disorders.
Eye or vision problems.
Cognitive impairment such that informed consent cannot be obtained, or that participant would not be safe with the protocol.
Medication that could make the participant drowsy or tired during the experiment.
Master Protocol of Two Independent, Randomized, Double-Blind, Phase 3 Studies Comparing Efficacy and Safety of Frexalimab (SAR441344) To Teriflunomide in Adult Participants With Relapsing Forms of Multiple Sclerosis
A study that looks at the efficacy of Frexalimab compared to standard of care drug, Teriflunomide, for adults with relapsing forms of MS.
The purpose of this clinical trial is to compare the efficacy and safety of investigational products in adult participants with relapsing forms of multiple sclerosis. There will be about 22 in person visits over 3.5 years that consist of monthly IV medication administration, monthly oral tablet medication dispensation, Magnetic resonance imaging (MRI) roughly every 6 months, monthly blood draws for lab work, vitals, ECG, and clinical outcome assessments. 13 of these visits are within the first 12 months of the study. All study activities will be done at the Penn State Health Hershey Medical Center in the Neurology Clinic at 30 Hope Drive and the Clinical Research Center (CRC) in the main hospital.
Up to $4300
Diagnosed with remitting relapsing multiple sclerosis (RRMS) with a documented relapse within the previous year, two documented relapses within two years, or one documented Gd enhancing lesion on an MRI scan within the previous year.
Must agree to use contraception for both male and female participants.
Must be able to sign informed consent or have a legally authorized representative to sign.
History of infectious disease/serious psychiatric illness/active substance use disorder/cirrhosis, acute liver disease/malignancy/autoimmune, cardiovascular, neurological disorders/any other history or presence of significant other concomitant illness.
Treatment with lymphoid irradiation, bone marrow transplantation, mitoxantrone, alemtuzumab, cladribine, daclizumab, cyclophosphamide, other strongly immunosuppressive treatments with very long-lasting effects, equal to or over 3 months of teriflunomide.
Previous exposure to frexalimab, other investigational drug trials, allergy or sensitivity to any of the study interventions.
Contraindication for MRI: pacemaker, metallic implants/presence of metallic material in high risk areas, known history of allergy to any contrast medium, or history of claustrophobia that would prevent completion of all protocol scheduled MRI scans.
A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib
The main purpose of the study is to find out if patients treated with remibrutinib may experience fewer MS relapses (also called clinical attacks, exacerbations or flare ups) than patients treated with teriflunomide (also known as Aubagio®). Teriflunomide is an approved medication for the treatment of relapsing MS
This study requires you to take a medication. This study consists of a core part (21 in person visits over 2.5 years) and an extension part (18 in person visits over 5 years). Study activities consist of blood draws for labs every 3 months, vitals (blood pressure readings, heart rate, height and weight), physical exam, electrocardiogram (ECG), clinical outcome assessments, a participant diary that will be filled out during treatment, and an optional magnetic resonance imaging (MRI) sub-study. All study activities will be done at the Penn State Health Hershey Medical Center in the neurology clinic at 30 Hope Drive and clinical research center (CRC) in the main hospital.
$3960
Diagnosed with remitting relapsing multiple sclerosis (RRMS) with a documented relapse within the previous year, two documented relapses within previous two years, or one documented Gd enhancing lesion on an MRI scan within the previous year.
Must be neurologically stable for 1 month prior to joining the study (including no MS relapse in this time period)
Must agree to use contraception for both male and female participants
Must be able to sign informed consent or have a legally authorized representative to sign.
MS disease duration of more than 10 years
Any history or presence of significant concomitant illness.
Treatment with some common MS medications such as cladribine, cyclophosphamide, remibrutinib or other BTKi, alemtuzumab
Optional sub-study: contraindication for MRI: any metal in the body or history of metal fragments, claustrophobia, known allergy to contrast medium.
ALL ALS-PREVENT
The primary purpose of this study is to collect samples and health information from individuals who are genetically at risk for ALS to better understand ALS and how the disease progresses.
Study visits will be conducted both in an in-clinic setting and remotely with 14 visits over the course of 36 months (3 years). Participants will complete a total of 10 visits over the course of 36 months (3 years). There will be a screening visit onsite in the clinic; 3 in-person onsite clinic visits once a year; and 6 remote visits once every 4 months. Participants and will need access to a personal device (i.e. a computer and/or smartphone or tablet) and an internet connection to participate in this study. Biospecimens will be collected alongside COA to support biofluid biomarker analyses. Biospecimens will include plasma, serum, RNA, whole blood for generation of induced pluripotent stem cells (iPSCs) and DNA for whole genome sequencing, and cerebrospinal fluid (CSF) via lumbar puncture (LP). To supplement annual in-person visits, participants will undergo additional biofluid collection (plasma, serum and whole blood) which will be remotely collected through home phlebotomy.
Up to $780
Capable of providing informed consent and willing to follow study procedures.
First-degree relative of known carrier of ALS gene OR First-degree relative of individual with ALS and/or FTD in a family with a “compelling family history” of ALS/FTD, regardless of whether genetic testing has occurred in symptomatic family members.
Access to a smartphone, computer, or tablet, and internet (need not be in the home – access to a public library or other available computer with internet connection is sufficient)
Genetic Testing Sub-Study: Currently enrolled in the PREVENT ALS Study
Significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, active suicidal ideation, suicide attempt, or untreated major depression that would interfere with the study procedure.
Clinically significant, unstable medical condition that would render the participant unlikely to be able to complete 12 months of follow-up, according to Investigator's judgment.
Optional Lumbar Puncture: Medically unable to undergo LP; allergy to Lidocaine or other local anesthetic agents; use of anticoagulant medication or antiplatelet medications (aside from aspirin 81mg) that cannot be safely withheld prior to LP.
Genetic Testing Sub-Study: Presence of unstable psychiatric illness (psychosis, active suicidal ideation, suicide attempt, or untreated major depression) in whom predictive genetic testing would confer a high risk of harm.