N/A N=2 Diagnostic

Presurgical Motor Mapping With Transcranial Magnetic Stimulation (TMS)

Epilepsy

Bottom Line

View on ClinicalTrials.gov: NCT02741193 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2023

Primary outcome: Primary: Average Distance Between Positive Motor Mapping Sites of DCS

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: The Magstim Rapid2, (Device)
Age: Pediatric, Adult · 12+ yrs
Sex: All
Sponsor: NYU Langone Health
Primary completion: Nov 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Average Distance Between Positive Motor Mapping Sites of DCS	—	—
PRIMARY Average Distance Between Positive Motor Mapping Sites of nTMS	—	—
PRIMARY Average Distance Between Positive Motor Functional Sites of fMRI	—	—
PRIMARY Average Distance Between Positive Motor Functional Sites of nTMS	—	—

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.

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02741193). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.