NCT02741193

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 18, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

September 10, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2016

Completed
6.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2023

Completed
9 months until next milestone

Results Posted

Study results publicly available

November 14, 2023

Completed
Last Updated

November 14, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

April 8, 2016

Results QC Date

October 27, 2023

Last Update Submit

October 27, 2023

Conditions

Epilepsy

Keywords

Transcranial magnet stimulation (nTMS)Brainsight NeuronavigationElectromyographyEMG

Outcome Measures

Primary Outcomes (4)

  • Average Distance Between Positive Motor Mapping Sites of DCS

    30 minutes

  • Average Distance Between Positive Motor Mapping Sites of nTMS

    30 minutes

  • Average Distance Between Positive Motor Functional Sites of fMRI

    30 minutes

  • Average Distance Between Positive Motor Functional Sites of nTMS

    30 minutes

Study Arms (1)

nTMS

EXPERIMENTAL

Patients will receive a single-pulse TMS mapping of the motor area for the following reasons to determine the motor threshold, measure concurrent EMG, and mapping of the upper extremity.

Device: The Magstim Rapid2,

Interventions

The Magstim Rapid2,DEVICE

Transcranial Magnetic Stimulation, which is a microprocessor-controlled machine which delivers both single and repetitive transcranial magnetic stimulation (TMS). single and repetitive transcranial magnetic stimulation (TMS). TMS will be applied as single pulses to determine motor evoked potentials (MEPs), there will be no modulation of cortical excitability.

nTMS

Eligibility Criteria

Age12 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years of age
  • Planned neurosurgery involving implantation subdural electrodes over the precentral gyrus

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Results Point of Contact

Title
Anli Liu
Organization
NYU Langone Health
Anli.Liu@nyulangone.org
9294552340

Study Officials

  • Anli Liu, MD, MA

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

April 8, 2016

First Posted

April 18, 2016

Study Start

September 10, 2016

Primary Completion

November 17, 2016

Study Completion

February 23, 2023

Last Updated

November 14, 2023

Results First Posted

November 14, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)