Noninvasive VNS to Facilitate Excitability in Motor Cortex

August 9, 2023 updated by: Bashar Badran, Medical University of South Carolina

Combining Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) With Transcranial Magnetic Stimulation (TMS) to Enhance Cortical Excitability

Transcranial Magnetic Stimulation (TMS) positively influences motor rehabilitation in stroke recovery. Transcutaneous auricular vagus nerve stimulation (taVNS) has shown effects on cortical plasticity. We investigate whether combination of TMS and taVNS is more effective at motor cortex excitability than either modality alone.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators aim to determine the effects of taVNS on motor cortex excitability. The hypothesis is that taVNS alone (sham rTMS + active taVNS) will induce increases in motor cortex excitability (post-stimulation compared to baseline). The investigators expect these changes will be of a lesser magnitude than those of TMS alone (active rTMS + sham taVNS) due to the indirect mechanistic approach of taVNS. Another aim is to determine whether taVNS-paired TMS is more effective at inducing cortical excitability than TMS alone, as it is hypothesized that pairing two forms of neuromodulation (active rTMS + active taVNS) will increase TMS-induced cortical excitability in the motor cortex when compared to single modality approaches (active rTMS + sham taVNS; sham rTMS + active taVNS). Furthermore, it is expected that this increase is timing sensitive, and the paired approach will induce larger TMS-induced cortical excitability compared to unpaired neuromodulation (active taVNS + active taVNS).

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 18-80
  • endorsing good health

Exclusion Criteria:

  • no TMS-induced motor cortex excitability changes in response to 20Hz motor cortex rTMS
  • active psychiatric or neurological disorders
  • history of CNS disease, concussion, overnight hospitalization, or other neurologic sequelae, tumors, seizures, frequent or severe headaches
  • metal implanted above the neck
  • currently taking seizure reducing medications
  • currently taking psychotropic medications
  • any psychotropic medication taken within 5 half-lives of procedure time
  • abuse or dependence of drugs (excluding nicotine and caffeine)
  • currently taking medications that lower the seizure threshold
  • taking any of the stimulants, thyroid medication, or steroids
  • implanted devices/ferrous metal of any kind
  • history of seizure or seizure disorder
  • inability to determine motor threshold.
  • Pregnant females and children under the age of 18 will be excluded for safety reasons
  • No vulnerable populations or special classes of subjects will be considered for participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active taVNS, Active TMS
Device: Transcranial Magnetic Stimulation
transcranial magnetic stimulation delivers magnetic pulses to the brain through the scalp/skull
Device: transcutaneous auricular vagus nerve stimulation (taVNS)
non-invasive vagus nerve stimulation delivers electricity to the ear
Sham Comparator: Sham taVNS, Active TMS
Device: Transcranial Magnetic Stimulation
transcranial magnetic stimulation delivers magnetic pulses to the brain through the scalp/skull
Device: transcutaneous auricular vagus nerve stimulation (taVNS)
non-invasive vagus nerve stimulation delivers electricity to the ear
Sham Comparator: Active taVNS, Sham TMS
Device: Transcranial Magnetic Stimulation
transcranial magnetic stimulation delivers magnetic pulses to the brain through the scalp/skull
Device: transcutaneous auricular vagus nerve stimulation (taVNS)
non-invasive vagus nerve stimulation delivers electricity to the ear
Sham Comparator: Sham taVNS, Sham TMS
Device: Transcranial Magnetic Stimulation
transcranial magnetic stimulation delivers magnetic pulses to the brain through the scalp/skull
Device: transcutaneous auricular vagus nerve stimulation (taVNS)
non-invasive vagus nerve stimulation delivers electricity to the ear

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change of EMG-recorded Motor-evoked potential from baseline to immediately after intervention
Time Frame: Every 5 minutes up to 20 minutes following intervention end
The study uses Motor Evoked Potentials (MEPs), which are EMG measurements of a targeted movement (in other words, electromyography on the thenar muscles will sense a "twitch" that may occur due to motor cortex stimulation by TMS). The sensitivity of the motor cortex to stimulation is correlated to the degree of thumb twitch. This MEP will be used as a functional measure of changes in motor cortex excitability, as the amount of muscle twitch (MEP) should change if the cortex is more sensitive to TMS stimulation. The baseline measurement will be taken in the 60 seconds preceding the intervention; the intervention will last 20 minutes; post-intervention MEPs will be measured at 1, 5, 10, 15, and 20 minutes following the end of the intervention.
Every 5 minutes up to 20 minutes following intervention end

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2020

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

September 30, 2019

First Submitted That Met QC Criteria

October 15, 2019

First Posted (Actual)

October 17, 2019

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00089851

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share data except through peer-review.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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