Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT04062305
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-28
First Post:
2019-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
nTMS in Planning Stereotactic Radiosurgery in Patients With Brain Metastases in the Motor Cortex
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Feasibility of Navigated Transcranial Magnetic Stimulation (nTMS) of Patients Treated With Stereotactic Radiosurgery for Brain Metastases in the Motor Cortex: A Comprehensive Cross-Sectional Assessment
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial studies how well nTMS works in planning for stereotactic radiosurgery in patients with brain metastases in the motor cortex. Stereotactic radiosurgery is a type of radiation therapy that delivers high doses of radiation, which can sometimes lead to damage occurring to the brain and surrounding areas. The motor cortex (the part of the nervous system that controls muscle movement), however, currently has no radiation dose limit. nTMS is a non-invasive tool that uses sensors on a patient's muscle to trace the location in their brain that controls that muscle and is currently used by doctors to decide where to operate so as not to damage the motor nerves. nTMS may effectively help plan radiation treatment using SRS and help doctors decide on how much radiation can be used on motor nerves.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine if the use of navigated transcranial magnetic stimulation (nTMS) in the radiation oncology clinic is feasible.
SECONDARY OBJECTIVES:
I. To investigate the relationship of stereotactic radiosurgery (SRS) dosimetry and lesion involvement in the motor tracts identified using nTMS and the presence or absence of motor deficits evaluated by objective and subjective measures (Manual Ability Measure \[MAM\]-20, Euroqol \[EQ\]-5 Dimensional \[D\]-5 Level \[L\], and MD Anderson Symptom Inventory \[MDASI\]-Brain Tumor \[BT\] questionnaires).
II. To determine if nTMS of contralateral motor tracts provides a viable internal control, considering handedness.
III. To aid in the design of a prospective, randomized clinical trial that will limit radiation dose to brain metastases located in close proximity to the motor cortex with the goal of improving functional and quality of life outcomes measured by occupational therapy tasks and the MAM-20, EQ-5D-5L, and MDASI-BT questionnaires.
IV. To explore the utility of electroencephalography (EEG) in correlation with nTMS and reported functional outcomes measured by occupational therapy tasks and the MAM-20, EQ-5D-5L, and MDASI-BT questionnaires.
OUTLINE:
Patients undergo nTMS over 1 hour. Patients also perform 4 tasks that test grip and pinch strength and the ability to use and feel with their hands for 1 hour.
I. To determine if the use of navigated transcranial magnetic stimulation (nTMS) in the radiation oncology clinic is feasible.
SECONDARY OBJECTIVES:
I. To investigate the relationship of stereotactic radiosurgery (SRS) dosimetry and lesion involvement in the motor tracts identified using nTMS and the presence or absence of motor deficits evaluated by objective and subjective measures (Manual Ability Measure \[MAM\]-20, Euroqol \[EQ\]-5 Dimensional \[D\]-5 Level \[L\], and MD Anderson Symptom Inventory \[MDASI\]-Brain Tumor \[BT\] questionnaires).
II. To determine if nTMS of contralateral motor tracts provides a viable internal control, considering handedness.
III. To aid in the design of a prospective, randomized clinical trial that will limit radiation dose to brain metastases located in close proximity to the motor cortex with the goal of improving functional and quality of life outcomes measured by occupational therapy tasks and the MAM-20, EQ-5D-5L, and MDASI-BT questionnaires.
IV. To explore the utility of electroencephalography (EEG) in correlation with nTMS and reported functional outcomes measured by occupational therapy tasks and the MAM-20, EQ-5D-5L, and MDASI-BT questionnaires.
OUTLINE:
Patients undergo nTMS over 1 hour. Patients also perform 4 tasks that test grip and pinch strength and the ability to use and feel with their hands for 1 hour.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: