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Enrolling by invitation NCT06641271

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

No phase Interventional Multiple Sclerosis (MS) - Relapsing-remitting Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Closed Loop Trans-Auricular Vagus Nerve Stimulation System, Placebo.
Who it may be relevant to
Registry conditions: Multiple Sclerosis (MS) - Relapsing-remitting, Multiple Sclerosis. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Vagus Nerve Stimulation to Promote Remyelination in Multiple Sclerosis

Overview

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 throughout the study, motor, disability, and neurophysiological assessments will be administered, including the Timed 25-Foot Walk Test, Expanded Disability Status Scale (EDSS), Upper Extremity portion of the Fugl-Meyer Assessment, Dellon-Modified Moberg Pick-Up Test, Multiple Sclerosis Impact Scale-29 (MSIS-29), motor evoked potentials (MEPs), and visual evoked potentials (VEPs). MRI assessments will also be performed to evaluate exploratory imaging metrics of potential remyelinative efficacy.

Interventions

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

Primary outcome measures

  • Frequency of adverse events in response to paired-taVNS treatment [Time frame: End of Study (6 months)]
Secondary outcome measures (9)
  • Change from baseline in time to complete the grooved peg test [Time frame: End of Study (6 months)]
  • Change from baseline of score of the upper extremity portion of the Fugl-Meyer Assessment [Time frame: End of Study (6 months)]
  • Change from baseline score of the Expanded Disability Status Scale [Time frame: End of Study (6 months)]
  • Change in time from baseline to complete the timed 25 foot walk test [Time frame: End of Study (6 months)]
  • Change from baseline in composite disability metric [Time frame: End of Study (6 months)]
  • Change in Dellon-Modified Moberg Pick-Up Test [Time frame: End of Study (6 months)]
  • Change from baseline in patient reported outcomes from the multiple sclerosis impact scale 29 [Time frame: End of Study (6 months)]
  • Motor Evoked Potential [Time frame: End of Study (6 months)]
  • Visual Evoked Potential [Time frame: End of Study (6 months)]

Eligibility criteria

Inclusion criteria

  • All participants ages 18-70 with diagnosis of multiple sclerosis at least 30 days from last relapse
  • Baseline grooved peg test time greater than or equal to 91 seconds for completion of the task (2 standard deviation above 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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Clinical Translational Research Center at CU Anschutz — Aurora

Identifiers

NCT: NCT06641271 · 22-1451

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗