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

NCT ID: NCT06641271

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-21
• Study Completion Date: 2027-11-30

Brief 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 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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Experimental - Active Stimulation

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

Group Type: EXPERIMENTAL

Closed Loop Trans-Auricular Vagus Nerve Stimulation System

Intervention Type: DEVICE

A closed loop system that delivers stimulation to the vagus nerve via the ear non-invasively following a trigger event.

Control - Sham Stimulation

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

Group Type: SHAM_COMPARATOR

Placebo

Intervention Type: DEVICE

A closed-loop vagus nerve stimulation device that can deliver sham stimulation to the ear to simulate stimulation of the vagus nerve.

Interventions

Closed Loop Trans-Auricular Vagus Nerve Stimulation System

A closed loop system that delivers stimulation to the vagus nerve via the ear non-invasively following a trigger event.

Intervention Type: DEVICE

Placebo

A closed-loop vagus nerve stimulation device that can deliver sham stimulation to the ear to simulate stimulation of the vagus nerve.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Bennett, MD

Role: PRINCIPAL_INVESTIGATOR

Anschutz Campus - School of Medicine - Neurology

Locations

Clinical Translational Research Center at CU Anschutz

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Adrienne Ellett, MS

Role: CONTACT

adrienne.ellett@cuanschutz.edu

7204280944

Pamela David Gerecht

Role: CONTACT

pamela.davidgerecht@cuanschutz.edu

(303)724-4134

Facility Contacts

Colorado Clinical and Translational Sciences Institute

Role: primary

CCTSI.Helpdesk@ucdenver.edu

303-724-1222

Other Identifiers

22-1451

Identifier Type: -

Identifier Source: org_study_id