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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04062305
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	M.D. Anderson Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Caroline Chung
Principal Investigator Affiliation	M.D. Anderson Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Metastatic Malignant Neoplasm in the Brain, Radiation Therapy Recipient
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

Experimental: Diagnostic (nTMS, sensory testing)

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.

Interventions

Behavioral: - Hand Function Test

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

Procedure: - Navigated Transcranial Magnetic Stimulation

Undergo nTMS

Other: - Quality-of-Life Assessment

Ancillary studies

Other: - Questionnaire Administration

Ancillary studies

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

M D Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

M D Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Caroline Chung

[email protected]

713-563-2300

Clinical Trial Finder