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Noninvasive VNS to Facilitate Excitability in Motor Cortex

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ClinicalTrials.gov Identifier: NCT04130646
Recruitment Status : Not yet recruiting
First Posted : October 17, 2019
Last Update Posted : November 11, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Bashar Badran, Medical University of South Carolina

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stroke Stroke Sequelae Motor Activity Device: Transcranial Magnetic Stimulation Device: transcutaneous auricular vagus nerve stimulation (taVNS) Early Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Combining Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) With Transcranial Magnetic Stimulation (TMS) to Enhance Cortical Excitability
Estimated Study Start Date : November 25, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : June 1, 2020

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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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Responsible Party: Bashar Badran, Dr. Badran, PhD, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT04130646     History of Changes
Other Study ID Numbers: 00089851
First Posted: October 17, 2019    Key Record Dates
Last Update Posted: November 11, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share data except through peer-review.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bashar Badran, Medical University of South Carolina:
stroke
recovery
TMS
VNS
motor
motor cortex
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases