Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Malignant Neoplasm in the Brain | Brain Neoplasm | PROBABILISTIC | 0.70 |
| Radiation Therapy Recipient | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hand Function Test | Behavioral | — | UNRESOLVED |
| Navigated Transcranial Magnetic Stimulation | Procedure | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (nTMS, sensory testing)
- description
- 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.
- interventionNames
- Behavioral: Hand Function Test
- Procedure: Navigated Transcranial Magnetic Stimulation
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (4)
- measure
- Operational feasibility of navigated transcranial magnetic stimulation (nTMS)
- timeFrame
- Up to 1 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available