Trial Outcomes & Findings for Noninvasive VNS to Facilitate Excitability in Motor Cortex (NCT NCT04130646)

NCT ID: NCT04130646

Last Updated: 2025-04-20

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: every 10 minutes following for 30 minutes
• Results posted on: 2025-04-20

Participant Flow

Participant milestones

Measure	TMS and taVNS Transcranial Magnetic Stimulation: transcranial magnetic stimulation delivers magnetic pulses to the brain through the scalp/skull transcutaneous auricular vagus nerve stimulation (taVNS): non-invasive vagus nerve stimulation delivers electricity to the ear
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Noninvasive VNS to Facilitate Excitability in Motor Cortex

Baseline characteristics by cohort

Measure	4 Separate Visits of TMS/taVNS n=12 Participants Transcranial Magnetic Stimulation: transcranial magnetic stimulation delivers magnetic pulses to the brain through the scalp/skull transcutaneous auricular vagus nerve stimulation (taVNS): non-invasive vagus nerve stimulation delivers electricity to the ear
Age, Customized Age 18-65	12 Participants n=93 Participants
Sex: Female, Male Female	12 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Race/Ethnicity, Customized White, non-hispanic	12 Participants n=93 Participants
Region of Enrollment United States	12 Participants n=93 Participants

PRIMARY outcome

Timeframe: every 10 minutes following for 30 minutes

Population: The population was analyzed for safety. The number of participants with an adverse event was recorded.

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

Outcome measures

Measure	TMS and taVNS n=12 Participants Transcranial Magnetic Stimulation: transcranial magnetic stimulation delivers magnetic pulses to the brain through the scalp/skull transcutaneous auricular vagus nerve stimulation (taVNS): non-invasive vagus nerve stimulation delivers electricity to the ear
Safety of Combined taVNS and TMS	0 Participants

Adverse Events

TMS Combined With taVNS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Associate Professor-Faculty

Medical University of South Carolina

Phone: (843) 792-6076

Email: badran@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place