Study to Investigate Vagus Nerve Stimulation Paired With Motor Task for Remyelination and Functio… (NCT06641271) | Clinical Trial Compass
By InvitationNot Applicable
Study to Investigate Vagus Nerve Stimulation Paired With Motor Task for Remyelination and Functional Recovery
United States70 participantsStarted 2025-01-21
Plain-language summary
The goal of this clinical trial is to learn if stimulating the vagus nerve in combination with a motor task in people with multiple sclerosis can improve motor function. The main questions it aims to answer are:
* Is stimulating the vagus nerve safe and feasible after demyelinating episodes?
* Does a paired motor task with vagus nerve stimulation improve motor function with someone who has multiple sclerosis?
Researchers will compare active vagus nerve stimulation to a sham stimulation to see if the paired vagus nerve stimulation can improve motor control.
Participants will:
* Come in for study visits over a six month period. Study visits are three times weekly for the first month, then single follow up visits at two, three, and six months.
* During study visits, participants will complete 30 minutes of the paired vagus nerve stimulation with a motor task, specifically the grooved peg test.
* At various timepoints throughout the study, motor, disability, and neurophysiological assessments will be administered, including the Timed 25-Foot Walk Test, Expanded Disability Status Scale (EDSS), Upper Extremity portion of the Fugl-Meyer Assessment, Dellon-Modified Moberg Pick-Up Test, Multiple Sclerosis Impact Scale-29 (MSIS-29), motor evoked potentials (MEPs), and visual evoked potentials (VEPs). MRI assessments will also be performed to evaluate exploratory imaging metrics of potential remyelinative efficacy.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All participants ages 18-70 with diagnosis of multiple sclerosis at least 30 days from last relapse
* Baseline grooved peg test time greater than or equal to 91 seconds for completion of the task (2 standard deviation above mean multiple sclerosis score).
* Ability to sign informed consent
* Expanded disability status scale score (or estimated) of 2.5 or greater OR a clinical report of upper extremity dysfunction in their dominant hand
Exclusion Criteria:
* Current uncontrolled and/or clinically significant medical condition.
* History of seizures or epilepsy.
* Other central nervous system disease or significant brain trauma.
* Bacterial or viral infection within the prior 30 days.
* Prior treatment with total body irradiation, clemastine, bexarotene, or other experimental remyelinating agent.
* Recent suicide attempt or continued expressed suicidal ideation.
* Implanted devices, such as pacemakers, cochlear prosthesis, neuro-stimulators.
* Abnormal ear anatomy or ear infection.
* Pregnancy, lactation, or lack of use of contraception.
* Unable to walk 25 feet continuously
* Other significant disease or disorder that might impair study participation. Participants will be allowed to initiate or maintain background disease modifying therapy to reduce the risk of multiple sclerosis relapse and optimize recruitment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of adverse events in response to paired-taVNS treatment