Actively Recruiting
Study to Investigate Vagus Nerve Stimulation Paired With Motor Task for Remyelination and Functional Recovery
Led by University of Colorado, Denver · Updated on 2025-03-14
70
Participants Needed
1
Research Sites
144 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 in the study, motor and disability tests will be administered to see if there are any changes in motor control for that participants. These tests include the timed 25 foot walk test, expanded disability scale, the upper extremity portion of the Fugl-Meyer Assessment, and the Multiple Sclerosis Impact Scale - 29.
CONDITIONS
Official Title
Study to Investigate Vagus Nerve Stimulation Paired With Motor Task for Remyelination and Functional Recovery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Diagnosis of multiple sclerosis at least 30 days after last relapse
- Baseline grooved peg test time of 108 seconds or longer
- Ability to provide informed consent
- Expanded Disability Status Scale score of 2.5 or greater or clinical report of upper extremity dysfunction in dominant hand
You will not qualify if you...
- Uncontrolled or significant current medical conditions
- Primary progressive multiple sclerosis
- History of seizures or epilepsy
- Other central nervous system diseases or significant brain trauma
- Bacterial or viral infection within the past 30 days
- Prior treatment with total body irradiation, clemastine, bexarotene, or other experimental remyelinating agents
- Recent suicide attempt or ongoing suicidal thoughts
- Implanted devices such as pacemakers, cochlear prosthesis, or neuro-stimulators
- Abnormal ear anatomy or ear infections
- Pregnancy, breastfeeding, or not using contraception
- Inability to walk 25 feet continuously
- Other significant diseases or disorders that could affect study participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Clinical Translational Research Center at CU Anschutz
Aurora, Colorado, United States, 80010
Actively Recruiting
Research Team
A
Adrienne Ellett, MS
CONTACT
P
Pamela David Gerecht
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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