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

NCT06641271 | Recruiting FDA Device

• 1 other identifier: 22-1451
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• 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.

  End of Study (6 months)

• 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.

  End of Study (6 months)

• 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.

  End of Study (6 months)

• 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.

  End of Study (6 months)

• Change from baseline in composite disability metric

  The fraction of participants in each intervention group at 6 months with improvement in disability will be determined by a composite disability metric composed of three elements: expanded disability status scale, timed 25 foot walk, and grooved peg test time. The metric will be deemed positive if there is a significant change in one or more of the measures as determined as follows: 1) decrease in expanded disability status scale score of 1 point (baseline expanded disability status scale score ≤5.5) or 0.5 point (baseline expanded disability status scale score of \>5.5); 2) 20% decrease in timed 25 foot walk test; or 3) 25% decrease in grooved peg test time. The composite disability metric will be quantified by a trained study personnel.

  End of Study (6 months)

• Change from baseline in patient reported outcomes from the multiple sclerosis impact scale 29

  The Multiple Sclerosis Impact Scale - 29 is a 29-item patient-reported measure of the physical and psychological impacts of multiple sclerosis. Participants are asked to rate how much their functioning and well-being has been impacted over the past 14 days on a 4-point scale. Higher scores indicate a greater disease impact.

  End of Study (6 months)

Study Arms (2)

Experimental - Active Stimulation

EXPERIMENTAL

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

Device: Closed Loop Trans-Auricular Vagus Nerve Stimulation System

Control - Sham Stimulation

SHAM COMPARATOR

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

Device: Placebo

Interventions

Closed Loop Trans-Auricular Vagus Nerve Stimulation System DEVICE

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

Experimental - Active Stimulation

Placebo DEVICE

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

Control - Sham Stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Clinical Translational Research Center at CU Anschutz

Aurora, Colorado, 80010, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jeffrey Bennett, MD

  Anschutz Campus - School of Medicine - Neurology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrienne Ellett, MS

CONTACT

7204280944; adrienne.ellett@cuanschutz.edu

Pamela David Gerecht

CONTACT

(303)724-4134; pamela.davidgerecht@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: January 21, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)