- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04062305
nTMS in Planning Stereotactic Radiosurgery in Patients With Brain Metastases in the Motor Cortex
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 Overview
Status
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Caroline Chung
- Phone Number: 713-563-2300
- Email: cchung3@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- M D Anderson Cancer Center
-
Contact:
- Caroline Chung
- Phone Number: 713-563-2300
-
Principal Investigator:
- Caroline Chung
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Ancillary studies
Other Names:
Ancillary studies
Complete tasks that test grip strength, pinch strength, and ability to use and feel with hands
Other Names:
Undergo nTMS
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operational feasibility of navigated transcranial magnetic stimulation (nTMS)
Time Frame: Up to 1 year
|
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
Time Frame: Up to 1 year
|
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
Time Frame: Up to 1 year
|
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
Time Frame: Up to 1 year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stereotactic radiosurgery (SRS) dosimetry and lesion involvement in the motor tracts
Time Frame: Up to 1 year
|
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
|
Presence or absence of motor deficits
Time Frame: Up to 1 year
|
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
|
Production of viable internal control by contralateral motor tract, accounting for handedness
Time Frame: Up to 1 year
|
Up to 1 year
|
|
Development of a clinical trial that will limit radiation dose to brain metastases
Time Frame: Up to 1 year
|
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
|
Utility of electroencephalography (EEG)
Time Frame: Up to 1 year
|
The utility of EEG in correlation with nTMS and reported functional outcomes will be explored.
|
Up to 1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Caroline Chung, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-0302 (Other Identifier: M D Anderson Cancer Center)
- NCI-2019-04992 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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