Search Results Within Category "Neurology"
Exploring Gender Differences in ADHD Through Narrative Competency
This is an interview study that will examine how people with and without ADHD tell stories. Eligible participants will be asked to attend a virtual televisit where they will tell three stories according to prompts given by study staff. We are recruiting both men and women for this study so we can determine if gender affects storytelling ability.
There will be one virtual visit on Zoom lasting approximately one hour. Participants will complete eligibility questionnaires, then eligible participants will be asked to tell three stories based on prompts from an investigator and complete one additional questionnaire.
$15
Diagnosis of Attention-Deficit Hyperactivity Disorder (ADHD)
No diagnosis of Attention-Deficit Hyperactivity Disorder (ADHD)
Native English speaker
Under 18 or over 30 years old
Psychosis, dyslexia, or other neurological impairment
Uncorrected hearing loss
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.
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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.
Functional magnetic resonance imaging (fMRI) and 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. In addition to behavioral testing, the study will use functional magnetic resonance imaging (fMRI) which enables us to take pictures of the brain while you are doing a task, using an instrument called an MRI scanner.
Participants will perform simple behavioral tasks either stand-alone or while being scanned; they may also complete questionnaires or rating scales.
Amount varies depending on the study
Normal or corrected-to-normal vision
No other sensory deficits
Adults who experience synesthesia
Must pass MRI safety screen (if applicable)
Minors under the age of 18
Individuals who fail the MRI safety screen (may still do behavioral studies)
Interactions between the olfactory, auditory, visual, and trigeminal systems
The purpose of this study is to use fMRI to identify and characterize the olfactory, auditory, visual and trigeminal-related brain networks. This research will then be use to enhance human health by laying the foundation to develop sensitive biomarkers to identify people who are at risk of developing brain disorders such as Alzheimer’s disease and Parkinson’s disease, where olfactory deficits are known preclinical symptoms.
Clear sinuses
Pregnant or lactating
Presence of a pacemaker, aneurysm clips or any metal in the body
A history of welding, grinding, and or claustrophobia
Neurological disease (stroke, tumor, Parkinson's) or Psychiatric disorder (bipolar, schizophrenia, etc)
The role of middle temporal and frontoparietal areas in limb motor control
The goal of this research is to understand the role of motion-processing areas on limb motor control. We will be using behavioral studies and combining that with functional brain imaging, EEG, and non-invasive brain stimulation using transcranial magnetic stimulation (TMS). TMS has been used in thousands of studies and is a very safe method to understand brain function for eye hand coordination.
There will be three visits. Participants will under go brain scanning. They will perform eye-hand coordination tasks by grabbing a robotic manipulandum. During the eye-hand coordination tasks, participants' brain activity will be measured using electroencephalography (EEG) and muscle activity using surface electromyography (EMG). Researchers will also apply transcranial magnetic stimulation (TMS) to temporarily inhibit and excite different brain areas. TMS is a noninvasive procedure that uses magnetic fields to stimulate nerve cells
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Participants should be right-hand dominant individuals
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
Participants should be able to lie still and perform behavioral tasks inside a magnetic scanner for up to 60 minutes
Any history of musculoskeletal disorders (e.g., carpal tunnel syndrome, any form of arthritis, fibromyalgia, tendinitis, or previous injury or surgery to the bones or joints in your neck, upper back, arms or hands in the last six months)
Eye or vision problems (e.g., cataracts, glaucoma, a detached retina, or macular degeneration)
Individuals with metallic implants will be excluded from the study. The metallic implant will make participation in a magnetic scanner impossible
Medication that could make the participant drowsy or tired during the experiment
Deprexis Study: An online program to reduce depression in MS – a phase III international multicenter randomized controlled trial
An online program to reduce depression in MS – a phase III international multicenter randomized controlled trial
Current Depression
No current treatment for depression
Internet access
Between the ages of 18-65
No current psychotherapy for depression
No substantial neurocognitive impairments
Started anti-depressants in the last 2 months
Defining the role of slow eye movements on limb motor control
The purpose of the study is to examine how slow eye movements called smooth-pursuit eye movements, contribute to hand-eye coordination. Participants will grasp a robotic manipulandum and using the manipulandum interact with virtual visual stimuli in an augmented-reality environment.
Should have normal vision or corrected vision
Participants should be able to sit upright on a chair for upto 2 hours
Participants should be able to grasp and move objects with their right hand
Participants should be able to provide informed consent
History of musculoskeletal disorders (e.g., carpal tunnel syndrome, arthritis, fibromyalgia, tendinitis, trigger finger, mallet finger, fracture, or previous injury to the bones or joints in your neck, upper back, arms or hands in the last six months)
eye or vision problems (e.g., cataracts, glaucoma, a detached retina or macular degeneration)
Cognitive impairment such that informed consent cannot be obtained.
Medication that could make the participant either drowsy or tired. Individuals who get tired with 2 hours of mild to moderate exercise are also not eligible to participate.
Examining Cortical Lateralization of Motor Learning through Transcranial Stimulation
The aim of this study is to understand how brain stimulation affects learning of a novel task on a virtual reality system. Participation involves playing virtual reality games during non-invasive brain stimulation.
Single visit, subjection to noninvasive brain stimulation during a reaching task.
25
18-40 years old (healthy young)
18-80 years old (stroke patient)
neurological disease
movement disorder
major psychiatric diagnosis
orthopedic damage to the arms
Implementation of a Transcutaneous CO2 Monitoring (ITCOM) Study in ALS
Amyotrophic lateral sclerosis (ALS) leads to respiratory failure due to chronic hypoventilation. The gold standard for measuring hypoventilationrequires an arterial blood gas, which is impractical in the outpatient setting due to invasiveness, pain, and need for specialized equipment. Recently, the Penn State Health Hershey ALS Clinic has implemented transcutaneous CO2 (TCO2) monitoring as standard of care clinical assessment. The overall goals of this study are to gather critical preliminary data for stakeholder-driven refinement of a TCO2 monitoring protocol within a busy ALS clinic and identify how TCO2 may enhance our understanding of standard respiratory measurements.
Participants will complete a survey related to their experience having their CO2 reading performed in the ALS Clinic.
$20 will be paid for every survey completed, for a maximum possible payment of $80 per person.
18 years of age or older.
Seated forced vital capacity (FVC) of less than 100% predicted normal.
Use of any type of non-invasive ventilation, except in the case of continuous positive airway pressure (CPAP) for obstructive sleep apnea
Use of diaphragm pacer
Use of a tracheostomy
In hospice or in active transition to hospice
A Second Intermediate Expanded Access Protocol for AmyotrophicLateral Sclerosis with CNM-Au8
The main purpose of this research study is to provide access to the investigational product, CNM-Au8 at a dose of 30mg per day, to up to 300 people living with ALS. The study wants to find out if CNM-Au8 is safe to take without causing too many side effects and can help people with ALS.
Participants will have a visit to see if they qualify to participate. Following this visit, they will return to the clinic for visits every 12 weeks and these visits will continue in 48-week periods until the treatment plan is discontinued. Participants will have one last visit 4 weeks after their last dose of the investigational medicine.
Able to understand and give written informed consent.
Male or female participants aged 18 years or greater (inclusive) at the time of ALS diagnosis.
Participants with a confirmed diagnosis of ALS per Gold Coast criteria as determined by a neurologist specializing in ALS (e.g., the site principal investigator or sub-investigator for this study).
Participant is able to daily consume up to 240 mL of the investigational drug suspension without substantial dysphagia, OR can intake the investigational product through a gastrostomy tube.
Participant has a history of any clinically significant or unstable medical condition (other than ALS) that may interfere with assessment of safety or compromise the study objectives.
Based on the investigator’s judgment, participants who may have difficulty complying with the protocol and/or any study procedures.
Within the prior 90-days the participant has had clinically significant findings on standard hepatic, hematologic, or renal safety assays.
Participant is currently involved in another placebo-controlled clinical trial (note: concomitant therapy with other investigational products is permitted with certain restrictions—see concomitant medications section below).
Home telemonitoring of bulbar function by acoustic measurement of swallowing and speech sounds in ALS
Most individuals with ALS experience changes in speech and swallowing over the course of the disease. In some, these are their initial indication of ALS. Identifying these changes, which may be rapid in some individuals, is complicated by the recent acceleration of virtual care delivery. This is a longitudinal home study of ALS patients to assess speech and swallowing function through use of smartphone application. The overall hypothesis is that this monitoring protocol can be used in a way that, 1) is satisfactory to the patient, 2) performs at least as well as standard clinical measures of dysarthria and dysphagia, and 3) resolves the development of emergence of speech and swallowing pathologies in ALS. Patients enrolling in this study will participate for approximately 24 weeks, during which they will have swallowing and speech tests performed, complete surveys, and perform audio recordings of speech on their cellphone. Healthy controls will be enrolled to judge the intelligibility of speech samples provided by patients in the study.
Patients enrolling in this study will participate for approximately 24 weeks, during which they will have swallowing and speech tests performed, complete surveys, and perform audio recordings of speech on a cellphone.
340
Possess a diagnosis of amyotrophic lateral sclerosis (ALS)
Have symptom onset within the last 6 years
Demonstrate changes in speech or swallowing as a result of ALS.
Possess a smartphone capable of running the study application or have home wireless internet service capable of transmitting study data from a study-issued smartphone.
Possess abnormal speech or swallowing processes due to a condition independent of their ALS diagnosis
A Phase 2, double-blind, placebo-controlled, parallel-group study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and potential efficacy of multiple doses of ONO-2808 in patients with Multiple System Atrophy (MSA)
The purpose of this clinical research study is to look at how safe the study drug, ONO-2808, is and whether it works when given to people with Multiple System Atrophy (MSA). The study will look at 3 different doses of the study drug, ONO-2808, compared to a placebo.
Screening Period (up to 6 weeks):The purpose of the Screening Period is to make sure the study is right for you. The Screening Period may be done over 2 days. This is to give you plenty of time to eat, rest and navigate through the study center/hospital at your own pace. Double-blind Treatment Period (24 weeks)The treatment period will consist of approximately 14 visits. Visit 1 (Baseline Visit), Visit 10 and Visit 13 will be done at the study center/hospital. Each visit may be done over 2 days. For the remaining visits, a nurse from IQVIA’s Research Nurse and Phlebotomy Solutions (RNPS) will come to your home to perform visit procedures. It is expected that these visits will take about 2 hours. All necessary safety measures will be taken during these visits. Your study medication may also need to be delivered to your home address. In this case, you or your caregiver will need to receive and sign for the study medication.You may be asked to come to the study center/hospital for extra visits (unscheduled), if the study doctor feels it is in your best interest.You may be allowed to continue taking medications to treat your MSA symptoms. Your study doctor will discuss this with you.After you complete the 24-week treatment period, you may be eligible to receive ONO-2808 in a separate study.Follow-up Period (4 weeks after last dose of study medication):You will have a follow-up visit about 4 weeks after your last dose of study medication. This visit will be done at your home in a similar way to your home visits during the Double-blind Treatment Period. It is expected that this visit will take about 2 hours.If you are eligible and volunteer to receive ONO-2808 after the 24-week treatment period, the follow-up visit will not be required.Early Termination Visit:If you stop the study early, you will be asked to come to the study center/hospital for an Early Termination Visit. This visit may be done over 2 days.Study visits include questionnaires; physical/neurological exams; vital signs and blood pressure measurements; ECGs; blood draws, including HIV and hepatitis testing; urine tests; and brain and liver MRIs. Pregnancy testing is required for female participants.
750.00
Diagnosis of clinically-established or clinically-probable MSA-parkinsonian type or MSA-cerebellar type
Participants at the early stages of the disease, defined as a maximum of 5 years since the onset of one of the following symptoms associated with MSA: parkinsonism, ataxia, orthostatic hypotension and/or urinary dysfunction
Ability to take at least 10 steps, turn around, and walk at least another 10 steps without the assistance of another person. Assistive devices are allowed.
Ability to swallow oral medication
Regular use of neuroleptics within 6 months prior to the initial evaluation by the study team
Patients with documented liver diseases or cirrhosis
Inability to undergo MRIs
Identifying the Cognitive, Psychological, and Neuroimaging Signatures of Head Trauma in Female Survivors of Intimate Partner Violence
We aim to investigate the impact exposure to head trauma in intimate partner violence (IPV) has on cognitive, psychological, and neural processes. Physical trauma as an outcome of IPV impacts an estimated 10 million people in the United States each year, with up to 90% of women exposed to IPV reporting episodes of abuse with head trauma. Women exposed to IPV are at a high-risk for developing mental illness and impaired cognitive function, which seems to be compounded in those with exposure to head trauma (HT).
The study includes interviews to discuss your any experiences you have had with physical abuse and head trauma, as well as current and past mental health history. Then you will complete questionnaires to see how you feel about your mental and physical health, followed by tests to assess your thinking abilities. Finally you will complete a magnetic resonance imaging (MRI) session to examine brain structure and function. All of the testing should take approximately 6 hours to complete.
$90
Aged 18-60
Has previously experienced intimate partner violence
Currently experiencing intimate partner violence (within the past 3 months)
Non-English speaker
Neurological and developmental disorders
Concussion-Prognosis
Using micro-RNA in saliva coupled with survey data as a prognostic tool with the ability to guide clinical management of concussions
During their baseline visit participants will complete a saliva swab, surveys, balance test and brief neurocognitive test.Day 7, participants will complete a saliva swab and 2 surveys.Day 30, participants will complete a saliva swab and 4 surveys.The baseline visit is the only in-person visit, day 7 and day 30 are done remotely.All surveys are completed online and day 7 and day 30 saliva swabs are sent home with the participants and sent back in a prepaid mailer on day 30.
$40
Diagnosis of concussion
POSTA: Protocol for Oral Somatosensation and Texture Appreciation
The purpose of this study is to collect normative data related to orofacial (lip/tongue) somatosensation (touch sensation) in healthy adults across the adult lifespan. This data will be compared to a select clinical population, those with Parkinson's disease.
There will be one data collection session lasting approximately 90 minutes. Participants may be invited back for a second session approximately 4 weeks later to repeat the testing sessionDuring the sessions, participants will answer a series of questions about their eating and drinking preferences, they will be asked to provide a speech sample by repeating a series of syllables, words, and sentences, as well as providing a spontaneous speech sample.All participants will be asked to complete a series of sensory tests where small plastic objects are placed on their lip, tongue, and finger tip. Participants will be asked when they feel the pressure/texture and when they do not.
English-speaking
Hearing and cognition within functional limits to complete speaking tasks
Clinical Group: Diagnosed with Parkinson's disease (PD)
have an active lesion to the lower face (ie cold sore, fever blister, etc)
have had a dental visit in the last month that involved general or local anesthesia to the oral region
exhibit symptoms of Tardive Dyskinesia secondary to anti-psychotic drug use
report current or recovering from a viral illness like Bell’s Palsy or Shingles
Linking olfactory deficits to memory impairment and AD neurodegeneration
The purpose of this voluntary research study is to find out more about changes in the brain as we age. This study is trying to determine if magnetic resonance imaging (MRI), genetic variations, amyloid positron emissions tomography (PET), neuropsychological testing, and smell tests can be used to evaluate memory loss and cognitive impairment.
You will be asked to come to the research site once a year for 5 years.Annual (and semi-annual) procedures include completing smell tests, neuropsychological tests, magnetic resonance imaging (MRI). One-time procedures include provide blood sample, amyloid PET scan (if indicated), and optional lumbar puncture.
Up to $250 a year
Smell impairment
Women who are pregnant or breastfeeding
Currently smoke
Have claustrophobia
Mindfulness, Neuroscience and Daily Life Study
This study will examine whether a guided drawing activity helps to reduce anxiety in young adults. This will add to our understanding of how drawing can be used to manage anxiety symptoms and bolster emotion regulation.
This study will require two in person lab visits that take approximately 2 hours each and separated by four weeks where participants will have their brain and heart rate activity monitored while completing mindfulness activities. After the first in person visit, participants will complete two 30 minute audio/questionnaire sessions a week for four weeks (8 total) before returning to the lab for the second visit where participants can expect to complete a similar experience as their first in person visit. Two weeks after the second in person lab visit, participants will complete a Qualtrics questionnaire that will take approximately 30 minutes to complete. Total overall participation of approximately 8 to 8 1/2 hours.
$175
Able to read, speak and write in English
Not able to read, speak and write in English
Modeling Transition Speeds in Elderly Human Walking
This study will involve elderly humans walking on a treadmill transitioning through prechosen speeds.
There will be one, two hour in person visit. Participants will change into specific lab provided clothing for study and reflective stickers will be placed on participants by the researcher. Participants will then get on the treadmill and will walk at prescribed constant speeds for about 5 minutes total. Then participants will perform 10 speed transition trials each of which lasts about 4 minutes.
$15
Can continuously walk for up to 4 minutes
Be able to follow verbal instructions
High BMI (>30)
Emotion Regulation and Mother-Infant Synchrony
The aim of this study is to better understand emotion regulation in infants by measuring brain, behavior, and mother-infant relational mechanisms. We plan to collect simultaneous brain activation in mothers and infants while they engage in a face-to-face interaction. We will then test associations between individual brain activation, mother-infant brain synchrony, and infant emotion regulation behaviors.
Participants complete questionnaires online, then come in for 1 in-person visit. Mother and baby complete a play and a neutral task while fNIRS is collected from them simultaneously.
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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
AIDP
The purpose of this study is to test the performance of a web-based system for automated review of MRI images across 21 sites in the Parkinson Study Group. Each site will perform imaging, clinical scales, diagnosis, and will upload the data to the web-based software tool. The clinical diagnosis will be blinded to the diagnostic algorithm and the imaging diagnosis will be compared to the movement disorders trained neurologist diagnosis.
Participants will attend two study visits that will include questionnaires, a physical exam and motor exams and an MRI (during one of the visits).
300
Diagnosed with a Parkinsonism (PD, MSA or PSP)
Predicting Concussion Outcomes with Salivary miRNA
The purpose of this study is to identify changes in salivary micro ribosomal nucleic acid (miRNA) expression that are predictive of symptom duration and severity following mild traumatic brain injury (mTBI) in children. The primary endpoints of this study are as follows:1)Characterization of brain-related miRNA in the saliva of 250 children with mTBI and 200 age- and gender-matched controls between the ages of five and twenty-three years.2)Identification of a set of salivary miRNAs that is predictive of duration and severity of mTBI symptoms.
Saliva collection and surveys at baseline, 7 days, and 30 Days
$20
Seen in the Penn State Pediatric Concussion Clinic within 2 weeks of most recent concussion
Periodontal disease
Ongoing seizure disorder, or other neurologic disorder
Drug or alcohol dependency
clinical diagnosis of severe TBI
An Intermediate Expanded Access Protocol with CNM-Au8for Amyotrophic Lateral Sclerosis for NIH Grant RFA-NS-23-012
The main purpose of this research study is to provide access to the investigational product, CNM-Au8 at a dose of 30mg per day, to up to 180 people living with ALS. The study wants to find out if CNM-Au8 is safe to take without causing too many side effects and can help people with ALS.
Participants will have a visit to see if they qualify to participate. Following this visit, they will return to the clinic for visits every 12 weeks and these visits will continue in 144-week periods until the treatment plan is discontinued. Participants will have one last visit 4 weeks after their last dose of the investigational medicine.
Male or female aged 18 years or greater at time of ALS diagnosis
Participants with a confirmed diagnosis of ALS as determined by a neurologist specializing in ALS
Participant is able to consume up to 240mL of investigational drug without substantial dsyhpagia or can take the investigational drug through a gastronomy tube
Participant has a history of clinical significant or unstable medical condition that may interfere with assessment of safety or compromise the study objectives
Based on the investigator’s judgment, participants who may have difficulty complying with the protocol and/or any study procedures.
Within the prior 90-days the participant has had clinically significant findings on standard hepatic, hematologic, or renal safety assays.
Participant is currently involved in another placebo-controlled clinical trial (note: concomitant therapy with other investigational products is permitted with certain restrictions—see concomitant medications section below).
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 questionnaires online, 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.
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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
Augmented Reality: Perceptions, Performance, and Language Enhancement
This is a single-center feasibility study assessing the Apple Vision Pro as a device for augmentative and alternative communication in patients with Amyotrophic Lateral Sclerosis who are experiencing impaired communication.Participants in this study will visit the study site once for approximately 1.5 hours. During the session, participants will complete questionnaires about their medical history, undergo an eye exam, and use an augmented reality headset that tracks the motion of the eyes to communicate.
Participants and their caregivers will complete a single visit at the Hershey Medical Center lasting approximately 1.5 hours. During this time, they will undergo an eye exam, answer a set of questionnaires, and use an augmented reality (AR) headset that tracks eye-gaze to communicate.
$25
Use of augmentative and alternative communication device device (including but not limited to: eye tracking, switch control, scanning interface, written or typed communication).
Score of 1 or 0 on the ALS Functional Rating Scale (ALSFRS-R, Cedarbaum1999) speech sub-score and/or score of 2, 1, or 0 ALSFRS-R handwriting sub-score.
Continuous use of face-mask noninvasive ventilator that would impair comfortable wearing of AVP headset for at least 60 minutes
History of visual impairment incompatible with device use
History of medical diagnoses that could be exacerbated by use of the augmented reality headset: uncontrolled migraines or chronic headache, dizziness, vertigo, or other inner ear conditions, dry eyes, skin allergies, seizures
Diagnosis of frontotemporal dementia or other severe cognitive impairment that is sufficient, in the opinion of the study neurologist, to interfere with the subject’s ability to provide informed consent and reliably complete questionnaires
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.
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.
Alzheimer’s Network for Treatment andDiagnostics (ALZ-NET)
ALZ-NET will follow and record information about people’s health, safety, brain scans, and long-term health outcomes during their regular memory care.
At specific time points throughout your participation in ALZ-NET, your memory care provider or designated staff will transfer data about your health, diagnosis, treatment, and brain imaging that are related to your memory concerns to the ALZ-NET operations center.These time points include at a 6-month, 12-month, 18-month, and 24-month timepoint, and once per year after that until your participation ends.
Patient or patient’s legally authorized representative (LAR) (e.g., spouse or legal guardian) has the ability to understand and provide signed and dated informed consent
Patient has a diagnosis of MCI or dementia with clinical suspicion of Alzheimer’s disease (AD)
If treatment is initiated at time of consent, the patient meets appropriate label requirements and treatment follows appropriate use recommendations for novel FDA-approved AD therapy/therapies
Patient’s treating clinician has made the decision to provide clinical care or treatment prior to patient consent and independently of the purpose of ALZ-NET