nTMS in Planning Stereotactic Radiosurgery in Patients With Brain Metastases in the Motor Cortex

NCT04062305 | Active Not Recruiting

• 2 other identifiers: 2019-0302NCI-2019-04992
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Therapy Recipient; Metastatic Malignant Neoplasm in the Brain

Outcome Measures

Primary Outcomes (4)

• Operational feasibility of navigated transcranial magnetic stimulation (nTMS)

  Will be determined to be operationally feasible on a patient if the images and data obtained from nTMS for the patient provide useful information to the radiation oncologist and if the radiation oncologist determines that this additional information would improve patient care. Will deem the use of nTMS to be operationally feasible overall if it is deemed operationally feasible on an underlying proportion of at least 90% potentially consented patients. Will calculate the proportions of operational and technical feasibility of the use of nTMS and their 80% confidence intervals (CIs). If the observed proportions are greater than or equal to 82%, the use of nTMS to be operationally and technically will be deemed feasible.

  Up to 1 year

• Technical feasibility of nTMS

  Will be determined to be technically feasible on a patient if the procedure of nTMS is able to be performed on the patient, resulting in mapped motor cortex data. If the patient is not able to complete the procedure for any reason, that patient's nTMS treatment will not be technically feasible. Will deem the use of nTMS to be technically feasible overall if it is deemed technically feasible on an underlying proportion of at least 90% potentially consented patients. Will calculate the proportions of operational and technical feasibility of the use of nTMS and their 80% CIs. If the observed proportions are greater than or equal to 82%, the use of nTMS to be operationally and technically will be deemed feasible.

  Up to 1 year

• Economic feasibility of nTMS

  Will be determined to be economically feasible if there are no additional costs to the patients and department, other than those outlined in the proposed budget.

  Up to 1 year

• Identification of the motor cortex by addition of nTMS

  The treating radiation oncologist will determine if the use of nTMS provides additional information over the standard atlas-based definition of the motor region if they state that they would have made adjustments to their treatment volume of the tumor based on the new nTMS data provided.

  Up to 1 year

Secondary Outcomes (5)

• Stereotactic radiosurgery (SRS) dosimetry and lesion involvement in the motor tracts

  Up to 1 year

• Presence or absence of motor deficits

  Up to 1 year

• Production of viable internal control by contralateral motor tract, accounting for handedness

  Up to 1 year

• Development of a clinical trial that will limit radiation dose to brain metastases

  Up to 1 year

• Utility of electroencephalography (EEG)

  Up to 1 year

Study Arms (1)

Diagnostic (nTMS, sensory testing)

EXPERIMENTAL

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.

Behavioral: Hand Function Test; Procedure: Navigated Transcranial Magnetic Stimulation; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Hand Function Test BEHAVIORAL

Complete tasks that test grip strength, pinch strength, and ability to use and feel with hands

Also known as: Hand Sensory Test

Diagnostic (nTMS, sensory testing)

Navigated Transcranial Magnetic Stimulation PROCEDURE

Undergo nTMS

Also known as: Navigated TMS, nTMS

Diagnostic (nTMS, sensory testing)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Diagnostic (nTMS, sensory testing)

Questionnaire Administration OTHER

Ancillary studies

Diagnostic (nTMS, sensory testing)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with brain metastases located in or near the motor cortex who have previously received SRS to that lesion within the prior 3-18 months
• Patients must be able to participate in nTMS of bilateral motor cortices
• Patients must be able to participate in an electromyography (EMG)
• Patient's must have utilized magnetic resonance imaging (MRI) for their previous SRS treatment planning
• Patient must be able to complete the Functional and Quality of Life questionnaires in English

You may not qualify if:

• Significant cognitive or psychiatric symptoms that prevent the ability to complete a physical exam, questionnaires, or participate in nTMS or EMG
• Poor performance status Karnofsky performance score (KPS \< 60) that prevents the ability to participate in a physical exam, nTMS, or EMG. Patients will not be excluded if they are not able to complete the exploratory EEG analysis
• Patients receiving any prior treatment that might impact their cognitive, psychiatric, or motor cortex function

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Caroline Chung

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

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: August 16, 2019
• First Posted: August 20, 2019
• Study Start: September 9, 2019
• Primary Completion (Estimated): May 6, 2027
• Study Completion (Estimated): May 6, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

US (1)