Vagus nerve stimulation combined with motor tasks for improving function in multiple sclerosis

Vagus Nerve Stimulation to Promote Remyelination in Multiple Sclerosis

This study is testing if using vagus nerve stimulation while doing a hand task can help people with relapsing-remitting multiple sclerosis improve their motor function.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Colorado, Denver (other)
• Locations: 1 site (Aurora, Colorado)
• Trial ID: NCT06641271 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of vagus nerve stimulation paired with a motor task on improving motor function in individuals with relapsing-remitting multiple sclerosis. Participants will undergo a series of study visits over six months, where they will receive either active or sham vagus nerve stimulation while performing the grooved peg test. The study aims to determine the safety and feasibility of this approach, as well as its potential to enhance motor control following demyelinating episodes. Researchers will assess motor and disability outcomes at various timepoints throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of relapsing-remitting multiple sclerosis who have experienced a relapse at least 30 days prior.

Not a fit: Patients with primary progressive multiple sclerosis or those with uncontrolled medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved motor function and recovery for patients with multiple sclerosis.

How similar studies have performed: While the specific combination of vagus nerve stimulation and motor tasks is novel, similar approaches have shown promise in other studies targeting neurological recovery.

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.

Where this trial is running

Aurora, Colorado

• Clinical Translational Research Center at CU Anschutz — Aurora, Colorado, United States (RECRUITING)

Study contacts

• Principal investigator: Jeffrey Bennett, MD — Anschutz Campus - School of Medicine - Neurology
• Study coordinator: Adrienne Ellett, MS

Conditions: Multiple Sclerosis - Relapsing-remitting, Multiple Sclerosis