Clinical trial NCT04062305: nTMS in Planning Stereotactic Radiosurgery in Patients With Brain Metastases in the Motor Cortex
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Metastatic Malignant Neoplasm in the Brain
Radiation Therapy Recipient
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-08-20
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Operational feasibility of navigated transcranial magnetic stimulation (nTMS)
timeFrame: Up to 1 year
measure: Technical feasibility of nTMS
timeFrame: Up to 1 year
measure: Economic feasibility of nTMS
timeFrame: Up to 1 year
measure: Identification of the motor cortex by addition of nTMS
timeFrame: Up to 1 year
Secondary outcomes:
measure: Stereotactic radiosurgery (SRS) dosimetry and lesion involvement in the motor tracts
timeFrame: Up to 1 year
measure: Presence or absence of motor deficits
timeFrame: Up to 1 year
measure: Production of viable internal control by contralateral motor tract, accounting for handedness
timeFrame: Up to 1 year
measure: Development of a clinical trial that will limit radiation dose to brain metastases
timeFrame: Up to 1 year
measure: Utility of electroencephalography (EEG)
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Caroline Chung
role: PRINCIPAL_INVESTIGATOR
References: