About this trial
With this project, the study group wants to investigate whether a postoperative navigated transcranial magnetic stimulation (nTMS) motor map can improve stereotactic radiosurgery (SRS) planning in patients who underwent resection for a brain metastasis near the primary motor cortex. Specifically, the map could allow for more precise location of motor eloquent tissue, thereby minimizing the radiation dose on these areas while preserving high radiation dose on target tissue (i.e. tumor cells).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Informed consent
Age ≥ 18 years
Cerebral metastasis within or adjacent to the primary motor cortex (≤10 mm)
Resection of tumor
Disqualifiers
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)
Prior cerebral radiation therapy within the affected precentral gyrus/affecting the planned SRS plan
Planned whole brain radiotherapy
Second lesion within 2 cm ipsilateral in the primary motor cortex
Trial design
Single group
Treatments tested in this trial
Navigated Transcranial Magnetic Stimulation (nTMS)
DeviceEvery patient will undergo a postoperative nTMS motor mapping, and both the "standard" and "nTMS-adapted" SRS plan will be created for every patient. The plan will be selected by the radiation oncologist, depending on whether at least 95% of the dose is administered to the target volume with the "nTMS-adapted" plan or not. Every patient then receives SRS.
Treatment groups
Trial outcomes
Primary outcomes
Within-patient difference in maximum dose
Within-patient difference in maximum dose (defined as the dose received by the most exposed 0.03 cc of the tissue) to functional M1 between the standard and nTMS-adapted SRS plans, provided that both plans achieve PTV coverage ≥95% and comply with standard organ-at-risk constraints
Secondary outcomes
Feasibility of plan selection
Proportion of patients in whom the nTMS-adapted plan is deliverable, defined as meeting PTV coverage ≥95% and standard OAR constraints
Target coverage (%) of both plans
Target coverage in %
Motor outcome
Motor outcome (MRCS score) of each patient, at the day of nTMS (as baseline), 3, 6 and 12 months after the first radiation session
Motor outcome
Motor outcome (House and Brackman) of each patient, at the day of nTMS (as baseline), 3, 6 and 12 months after the first radiation session
Sponsors and contacts
Click on the lead sponsor to view all of their trials.