CompletedNot Applicable

Presurgical Motor Mapping With Transcranial Magnetic Stimulation (TMS)

United States2 participantsStarted 2016-09-10

Plain-language summary

The aim of the study is to examine the degree of concordance between presurgical neuronavigation guided TMS (nTMS) and direct cortical stimulation (DCS) in identifying hand motor cortex in adults undergoing epilepsy surgery. Navigated transcranial magnet stimulation (nTMS), MagStim RapidStim2 Magnetic stimulation will be delivered to hand primary motor cortex, with positive and negative functional sites determined through surface electromyography (EMG). The study will involve patients ages 12-60 years, with planned neurosurgery involving implantation of intracranial subdural electrodes including over the precentral gyrus. Navigated transcranial magnet stimulation (nTMS), MagStim RapidStim2 Magnetic stimulation will be delivered to hand primary motor cortex, with positive and negative functional sites determined through surface electromyography (EMG). The primary outcome measure will be spatial correlation between topographic maps of hand motor representation obtained through nTMS compared to direct, extra-operative cortical stimulation performed as part of routine clinical care. A secondary outcome measure will be safety and tolerability of TMS in the epilepsy patients.

Who can participate

Age range

12 Years – 60 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: * 12-60 years of age * Planned neurosurgery involving implantation subdural electrodes over the precentral gyrus Exclusion Criteria: * Inability to sign informed consent . * Hemiparesis worse than 4-/5 on the side contra lateral to the planned implant * Inability to get an MRI, or MRI older than 2 years * Frequent (\>1 per day) motor seizures * Prior neurosurgery * Metal in the head, including shrapnel * Implanted stimulation devices, including DBS (Deep Brain Stimulator), RNS (Responsive Neurostimulator), VNS (Vagus Nerve Stimulator), PPM (Permanent Pacemaker) * Pregnancy * Use of a medication known to increase the risk of seizures, including certain antipsychotics (clozapine), bronchodilators (aminophylline, theophylline), immunomodulatory agents (cyclosporine), and antibiotics (penicillins, cephalosporins, amphotericin, imipenem)

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

Average Distance Between Positive Motor Mapping Sites of DCS

Timeframe: 30 minutes

Average Distance Between Positive Motor Mapping Sites of nTMS

Timeframe: 30 minutes

Average Distance Between Positive Motor Functional Sites of fMRI

Timeframe: 30 minutes

Average Distance Between Positive Motor Functional Sites of nTMS

Timeframe: 30 minutes

Trial details

NCT IDNCT02741193

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-11-17

Results submitted2023-10-27

View on ClinicalTrials.gov More Epilepsy trials

Plain-language summary

Who can participate

Age range

12 Years – 60 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.

What they're measuring

Average Distance Between Positive Motor Mapping Sites of DCS

Timeframe: 30 minutes

Average Distance Between Positive Motor Mapping Sites of nTMS

Timeframe: 30 minutes

Average Distance Between Positive Motor Functional Sites of fMRI

Timeframe: 30 minutes

Average Distance Between Positive Motor Functional Sites of nTMS

Timeframe: 30 minutes