Search Results
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.
REGIMEN-SPECIFIC APPENDIX FFOR ABBV-CLS-7262
We are doing this research to find out if ABBV-CLS-7262 can help with Amyotrophic Lateral Sclerosis (ALS). We also want to find out if ABBV-CLS-7262 is safe to take without causing too many side effects.
•Ask you to complete questionnaires about your general health and well-being [Baseline Visit and Weeks 4, 8, 16 and 24/Early Termination (ET) Visits] •Collect a blood sample for:oTesting the amount of study drug in your body [Weeks 4, 8, 16, and 24/ET]oTest certain hormone levels [Regimen Screening, Week 4, 16, and 24/ET]oTest for a bleeding disorder prior to lumbar puncture [Regimen Screening if not done at Master Protocol Screening Visit, Week 16] oBiomarker (including RNA) testing [Baseline Visit, Week 8, 16, and 24/ET]oOver the course of the placebo-controlled portion of this research study, total blood draw volume for the samples listed above will be approximately 32mL or 2 tablespoons per visit •Collect a urine sample for:oRoutine safety testing [Baseline Visit, Week 4, Week 8, 16, and 24/ET]oBiomarker testing [Baseline Visit, Week 8, 16, and 24/ET]•Collect electrocardiogram (ECG) to assess for cardiovascular safety [Baseline Visit, Week 8, 16, and 24/ET]•Collect your vital signs (blood pressure, breathing & heart rate, blood oxygen level, and temperature)•Perform a lumbar Puncture to collect spinal fluid [Baseline and Week 24 Visit]•If you are a woman of childbearing potential, you will be asked to complete a Menstrual Cycle Questionnaire throughout the duration of this regimen
You will receive payment for the following: 1.stipend of $50 per on-site visit; 2.stipend of $100 per lumbar puncture (LP requested Weeks 28 and 52); 3.reimbursement for travel of $65 per on-site visit.
Age 18 years or older
Capable of providing informed consent and complying with study procedures, in the SI’s opinion
Time since onset of weakness due to ALS ≤ 36 months at the time of the Master Protocol Screening Visit
Abnormal adrenal function, defined as confirmed abnormal random cortisol (<5 μg/dL) or ACTH (>2x upper limit of normal) at Regimen Specific Screening.
Any clinically significant ECG abnormalities, including QT interval corrected for heart rate using Fridericia’s correction formula (QTcF) of > 450 msec for males or > 470 msec for females at Master Protocol Screening.
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
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).
Pilot evaluation of a multisensory evoked potential brain-computer interface
A brain-computer interface (BCI) is a device that has the potential to restore communication by translating voluntarily controlled brain signals of intent. The P300 speller, a popular BCI paradigm, 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 control a spelling interface. Those with advanced ALS experiencing the loss of voluntary muscular control may also experience cognitive changes that result in decreased capacity for BCI control using the P300 speller.With this pilot study, we aim to validate the performance of a combination of eye tracking and standard sensory testing to quantify intact sensory and cognitive processes necessary for the generation of a P300 response. Additionally, we will evaluate the association of these correlates with performance on a multisensor P300 spelling task, where brain potentials are evoked using a combination of visual, auditory, and tactile stimuli. The goal is to demonstrate the viability of this system for future use in a patient group.
A brain-computer interface (BCI) is a device that has the potential to restore communication by direct translation of brain signals into computer commands. 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. During this 2-hour, single session 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.
Fluent in written and spoken English.
History of seizure disorder
Co-existing neurological or psychiatric illness that, in the opinion of the research team, exclude the subject from participation.
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
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
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).
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.