Study to Investigate Vagus Nerve Stimulation Paired With Motor Task for Remyelination and Functional Recovery

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Multiple Sclerosis; Multiple Sclerosis (MS) - Relapsing-remitting

Treatments: Device: Closed Loop Trans-Auricular Vagus Nerve Stimulation System; Device: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06641271

22-1451

Details and patient eligibility

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.
• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Experimental - Active Stimulation

Experimental group

Description:

Participants in this arm will receive active stimulation during the paired motor task.

Treatment:

Device: Closed Loop Trans-Auricular Vagus Nerve Stimulation System

Control - Sham Stimulation

Sham Comparator group

Description:

Participants in this arm will receive sham stimulation during the paired motor task to create a control to the experimental group.

Treatment:

Device: Placebo