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

Metastatic Malignant Neoplasm in the Brain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04062305
• Other study ID #: 2019-0302
• Secondary ID: NCI-2019-0499220
• Status: Recruiting
• Phase: N/A
• Start date: September 9, 2019
• Est. completion date: May 6, 2025

Study information

• Verified date: February 2024
• Source: M.D. Anderson Cancer Center
• Contact: Caroline Chung
• Phone: 713-563-2300
• Email: cchung3[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: May 6, 2025
• Est. primary completion date: May 6, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Metastatic Malignant Neoplasm in the Brain
• Neoplasms
• Radiation Therapy Recipient

Intervention

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
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Stereotactic radiosurgery (SRS) dosimetry and lesion involvement in the motor tracts	The relationship will be identified using nTMS. Dose volume histogram data for the motor cortex and motor tracts will be generated.	Up to 1 year
Secondary	Presence or absence of motor deficits	Will be determined by the Manual Ability Measure-20, Euroqol-5 Dimensional-5 Level, and MD Anderson Symptom Inventory - Brain Tumor questionnaires. Data analyses will be performed to determine correlations between objective/subjective deficits (based on the results of the questionnaires) and dose volume histogram data for the motor cortex and tracts.	Up to 1 year
Secondary	Production of viable internal control by contralateral motor tract, accounting for handedness		Up to 1 year
Secondary	Development of a clinical trial that will limit radiation dose to brain metastases	Will determine if trial can 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 based on meeting the primary objective of this study.	Up to 1 year
Secondary	Utility of electroencephalography (EEG)	The utility of EEG in correlation with nTMS and reported functional outcomes will be explored.	Up to 1 year

External Links

•   MD Anderson Cancer Center