Noninvasive VNS to Facilitate Excitability in Motor Cortex

NCT04130646 | Completed Results DMC FDA Device

• 1 other identifier: 00089851
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Stroke Sequelae; Motor Activity

Keywords

stroke; recovery; TMS; VNS; motor; motor cortex

Outcome Measures

Primary Outcomes (1)

• Safety of Combined taVNS and TMS

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

  every 10 minutes following for 30 minutes

Study Arms (1)

TMS combined with taVNS

EXPERIMENTAL

Device: Transcranial Magnetic Stimulation; Device: transcutaneous auricular vagus nerve stimulation (taVNS)

Interventions

Transcranial Magnetic Stimulation DEVICE

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

TMS combined with taVNS

transcutaneous auricular vagus nerve stimulation (taVNS) DEVICE

non-invasive vagus nerve stimulation delivers electricity to the ear

TMS combined with taVNS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80
• endorsing good health

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Stroke; Motor Activity

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Associate Professor-Faculty
• Organization: Medical University of South Carolina

badran@musc.edu

(843) 792-6076

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 17, 2019
• Study Start: March 15, 2020
• Primary Completion: June 12, 2023
• Study Completion: December 6, 2024
• Last Updated: April 20, 2025
• Results First Posted: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)