Noninvasive VNS to Facilitate Excitability in Motor Cortex (NCT04130646) | Clinical Trial Compass
CompletedNot Applicable
Noninvasive VNS to Facilitate Excitability in Motor Cortex
United States12 participantsStarted 2020-03-15
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety of Combined taVNS and TMS
Timeframe: every 10 minutes following for 30 minutes