Study to Investigate Vagus Nerve Stimulation Paired With Motor Task for Remyelination and Functional Recovery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Colorado, Denver
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All participants ages 18-65 with diagnosis of multiple sclerosis at least 30 days from last relapse
Baseline grooved peg test time greater than or equal to 108 seconds for completion of the task (1 standard deviation below 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
Disqualifiers
Current uncontrolled and/or clinically significant medical condition.
Primary progressive multiple sclerosis.
History of seizures or epilepsy.
Other central nervous system disease or significant brain trauma.
Trial design
Design model
Parallel
Treatments tested in this trial
Closed Loop Trans-Auricular Vagus Nerve Stimulation System
DeviceA closed loop system that delivers stimulation to the vagus nerve via the ear non-invasively following a trigger event.
Placebo
DeviceA closed-loop vagus nerve stimulation device that can deliver sham stimulation to the ear to simulate stimulation of the vagus nerve.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Experimental - Active StimulationExperimental treatment 1 intervention
Group B: Control - Sham StimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in time to complete the grooved peg test
The participant will complete the grooved peg test with their dominant hand and will be timed while doing so. The change in time to completion will be tracked over the study.
Time frame
End of Study (6 months)2
Change from baseline of score of the upper extremity portion of the Fugl-Meyer Assessment
The upper extremity portion of the Fugl-Meyer assessment evaluates movements of the upper limbs with score ranging from 0 - 66. A higher score indicates more function.
Time frame
End of Study (6 months)3
Change from baseline score of the Expanded Disability Status Scale
The expanded disability status scale scores range from 0 - 10, where 10 indicates full function.
Time frame
End of Study (6 months)4
Change in time from baseline to complete the timed 25 foot walk test
The timed 25 foot walk test is a performance measure where the participants walks 25 feet unassisted and the time to completion is recorded.
Time frame
End of Study (6 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov