Using navigated transcranial magnetic stimulation to guide radiosurgery planning near the motor cortex
Motor Eloquent Navigated Transcranial Magnetic Stimulation for Radiosurgery Planning
NA · Insel Gruppe AG, University Hospital Bern · NCT07415668
This project will test whether using nTMS after surgery can help plan stereotactic radiosurgery so people who had a brain metastasis removed near the motor cortex keep their motor function.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Bern) |
| Trial ID | NCT07415668 on ClinicalTrials.gov |
What this trial studies
Patients who had surgical removal of a brain metastasis within 10 mm of the primary motor cortex and are scheduled for postoperative stereotactic radiosurgery will undergo navigated transcranial magnetic stimulation (nTMS) to create a postoperative motor map. The nTMS-derived functional map will be incorporated into SRS planning to more precisely delineate motor-eloquent tissue and to adapt radiation dose constraints while maintaining high dose coverage of the tumor bed. Dosimetric plans with and without nTMS guidance will be compared and patients will be followed for neurological outcomes and signs of radionecrosis. The protocol aims to determine whether nTMS guidance reduces radiation exposure to functional motor areas without compromising target coverage.
Who should consider this trial
Good fit: Adults (≥18) who had resection of a brain metastasis within or adjacent (≤10 mm) to the primary motor cortex, are planned for postoperative stereotactic radiosurgery at Inselspital Bern, and have no contraindication to TMS.
Not a fit: Patients whose metastases are not near the motor cortex, who require whole-brain radiotherapy, have prior radiation affecting the planned SRS area, or who have contraindications to TMS are unlikely to benefit.
Why it matters
Potential benefit: If successful, this could lower radiation dose to motor areas and reduce the risk of post-radiation motor deficits while preserving tumor control.
How similar studies have performed: nTMS has been used successfully for preoperative motor mapping and small series suggest it can improve targeting and spare function in radiation planning, but large prospective outcome data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Informed consent 2. Age ≥ 18 years 3. Cerebral metastasis within or adjacent to the primary motor cortex (≤10 mm) 4. Resection of tumor 5. Eligible for and planned to undergo postresection radiosurgery at Inselspital Bern Exclusion Criteria: 1. Contraindication to TMS (e.g. Cochlear Implant, other metallic or electrical implants, excluding teeth and post craniotomy, Meniere's disease, pacemaker, deep brain stimulation electrodes, refractory convulsion, symptomatic tinnitus, depression diagnosed by a specialist, psychosis) 2. Prior cerebral radiation therapy within the affected precentral gyrus/affecting the planned SRS plan 3. Planned whole brain radiotherapy 4. Second lesion within 2 cm ipsilateral in the primary motor cortex 5. Infection or difficulties in wound healing within the last two weeks prior inclusion 6. Pregnancy
Where this trial is running
Bern
- University Hostpital Bern, Department of Neurosurgery Bern — Bern, Switzerland (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Metastases to Brain, metastasis, Navigated Transcranial Magnetic Stimulation, Stereotactic Radiosurgery