Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This study will be an open-label feasibility study which applies nTMS to subjects with incoming epilepsy surgery and pre-surgical motor mapping. No study-related medication changes are expected -- participants will remain compliant with their regular anticonvulsant regimen throughout each study phase. All patients will have undergone a complete history and neurological exam as part of their routine clinical care at the New York University (NYU) Comprehensive Epilepsy Center.
Fourteen (14) patients will undergo epilepsy surgery with expected subdural grid coverage over primary motor cortex. Potential subjects will be identified at the weekly multi-disciplinary epilepsy conference. Subjects must have a recent (<2 years) MRI scan, and registration of the TMS coil to the MRI scan via the Brainsight neuronavigation system will be utilized to guide TMS coil placement (Gugino et al 2001). When a presurgical fMRI (functional magnetic resonance imaging) is available which demonstrates the patient's hand knob, the fMRI will be used with the Brainsight neuronavigation system. Subjects will be recruited and consented during a presurgical clinical visit where the patient's primary epileptologist will introduce members of the research team.
nTMS mapping
Patients will receive a session of single-pulse TMS mapping of the motor area, at the outpatient TMS clinic at NYU Neurology Ambulatory Care Center, at 240 E 38th St 20th Floor prior their epilepsy surgery according to the following procedures:
After epilepsy surgery patients will receive the standard care for post-operative patients which including close monitoring in ICU overnight. Patients will be transferred to the floor for further clinical evaluation before discharge. Clinical outcome will be evaluated in the post-operative clinic visit within 1 month after discharge. The value of a clinical follow up is to evaluate for any discrepancy between nTMS and DCS, to determine which modality better predicts functional outcome. Any seizure recurrence or neurological deficit will be recorded at the follow-up clinical visit.
The trial is designed to detect strength of spatial correlation between topographic maps of hand motor representation obtained through noninvasive nTMS compared to direct, extra-operative cortical stimulation obtained as part of usual clinical evaluation during epilepsy surgery, as measured by (a) average distance between positive motor mapping sites of DCS compared to nTMS and (b) degree of concordance between positive and negative motor mapping sites between DCS and nTMS, to generate positive and negative predictive values, and (c) average distance between positive motor functional sites of fMRI compared to nTMS.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anli Liu, MD, MA | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University Langone Medical Center | New York | New York | 10016 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | nTMS | 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. The Magstim Rapid2,: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
No participants completed the trial nor had baseline characteristic data recorded.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | nTMS | 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. The Magstim Rapid2,: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Distance Between Positive Motor Mapping Sites of DCS | No participants had data collected for this outcome measure. | Posted | 30 minutes |
|
30 minutes.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | nTMS | 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. The Magstim Rapid2,: 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anli Liu | NYU Langone Health | 9294552340 | Anli.Liu@nyulangone.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 5, 2015 | Oct 27, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sex: Female, Male |
|
| Ethnicity (NIH/OMB) |
|
| Race (NIH/OMB) |
|
| Region of Enrollment | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| Primary | Average Distance Between Positive Motor Mapping Sites of nTMS | No participants had data collected for this outcome measure. | Posted | 30 minutes |
|
|
| Primary | Average Distance Between Positive Motor Functional Sites of fMRI | No participants had data collected for this outcome measure. | Posted | 30 minutes |
|
|
| Primary | Average Distance Between Positive Motor Functional Sites of nTMS | No participants had data collected for this outcome measure. | Posted | 30 minutes |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
Not provided
Not provided
Not provided