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OpenTrials
Completed

NCT Number: NCT04130646

Noninvasive VNS to Facilitate Excitability in Motor Cortex

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial Magnetic Stimulation

Device

transcranial magnetic stimulation delivers magnetic pulses to the brain through the scalp/skull

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Device

non-invasive vagus nerve stimulation delivers electricity to the ear

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Oct 17, 2019
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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