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Clinical Trials/NCT04130646
NCT04130646
Completed
Not Applicable

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

Medical University of South Carolina1 site in 1 country12 target enrollmentMarch 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Medical University of South Carolina
Enrollment
12
Locations
1
Primary Endpoint
Safety of Combined taVNS and TMS
Status
Completed
Last Updated
last year

Overview

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.

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).

Registry
clinicaltrials.gov
Start Date
March 15, 2020
End Date
December 6, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Safety of Combined taVNS and TMS

Time Frame: every 10 minutes following for 30 minutes

We will monitor and record adverse events of combined taVNS TMS intervention.

Study Sites (1)

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