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

Qualifiers

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

Treatments tested in this trial

  • Closed Loop Trans-Auricular Vagus Nerve Stimulation System
  • Placebo

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators