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

Not Applicable

Recruiting

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

• Registration Number: NCT06641271
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-10-11
• Study First Submitted QC: 2024-10-11
• Study First Posted: 2024-10-15
• Status Verified: 2024-12
• Study Start: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-06
• Primary Completion: 2027-11
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in time to complete the grooved peg test	End of Study (6 months)	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.
Change from baseline of score of the upper extremity portion of the Fugl-Meyer Assessment	End of Study (6 months)	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.
Change from baseline score of the Expanded Disability Status Scale	End of Study (6 months)	The expanded disability status scale scores range from 0 - 10, where 10 indicates full function.
Change in time from baseline to complete the timed 25 foot walk test	End of Study (6 months)	The timed 25 foot walk test is a performance measure where the participants walks 25 feet unassisted and the time to completion is recorded.
Change from baseline in composite disability metric	End of Study (6 months)	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.
Change from baseline in patient reported outcomes from the multiple sclerosis impact scale 29	End of Study (6 months)	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.

Trial Locations

Locations (1)

Clinical Translational Research Center at CU Anschutz; 🇺🇸 Aurora, Colorado, United States