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N/A N=12 Other

Noninvasive VNS to Facilitate Excitability in Motor Cortex

Stroke · Stroke Sequelae · Motor Activity

Bottom Line

View on ClinicalTrials.gov: NCT04130646 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Safety of Combined taVNS and TMS — 0 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Transcranial Magnetic Stimulation (Device); transcutaneous auricular vagus nerve stimulation (taVNS) (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Medical University of South Carolina
Primary completion
Jun 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Safety of Combined taVNS and TMS		 — —

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.

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
  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04130646). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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