Clinical trial · Interventional
Motor Eloquent Navigated Transcranial Magnetic Stimulation for Radiosurgery Planning
NCT07415668CI-TRIAL-00120504MENTORrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastases to Brain | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Navigated Transcranial Magnetic Stimulation (nTMS) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MENTOR
- description
- Every 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.
- interventionNames
- Device: Navigated Transcranial Magnetic Stimulation (nTMS)
Primary outcomes (1)
- measure
- Within-patient difference in maximum dose
- timeFrame
- 5 to 2 days before SRS
- description
- 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 (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (10)
- BACKGROUNDMilano MT, Grimm J, Niemierko A, Soltys SG, Moiseenko V, Redmond KJ, Yorke E, Sahgal A, Xue J, Mahadevan A, Muacevic A, Marks LB, Kleinberg LR. Single- and Multifraction Stereotactic Radiosurgery Dose/Volume Tolerances of the Brain. Int J Radiat Oncol Biol Phys. 2021 May 1;110(1):68-86. doi: 10.1016/j.ijrobp.2020.08.013. Epub 2020 Sep 11. PMID 32921513
- BACKGROUNDKondziolka D, Patel A, Lunsford LD, Kassam A, Flickinger JC. Stereotactic radiosurgery plus whole brain radiotherapy versus radiotherapy alone for patients with multiple brain metastases. Int J Radiat Oncol Biol Phys. 1999 Sep 1;45(2):427-34. doi: 10.1016/s0360-3016(99)00198-4. PMID 10487566
- BACKGROUNDLin NU, Lee EQ, Aoyama H, Barani IJ, Barboriak DP, Baumert BG, Bendszus M, Brown PD, Camidge DR, Chang SM, Dancey J, de Vries EG, Gaspar LE, Harris GJ, Hodi FS, Kalkanis SN, Linskey ME, Macdonald DR, Margolin K, Mehta MP, Schiff D, Soffietti R, Suh JH, van den Bent MJ, Vogelbaum MA, Wen PY; Response Assessment in Neuro-Oncology (RANO) group. Response assessment criteria for brain metastases: proposal from the RANO group. Lancet Oncol. 2015 Jun;16(6):e270-8. doi: 10.1016/S1470-2045(15)70057-4. Epub 2015 May 27. PMID 26065612
- BACKGROUNDRossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14. PMID 19833552
- BACKGROUNDSchwendner MJ, Sollmann N, Diehl CD, Oechsner M, Meyer B, Krieg SM, Combs SE. The Role of Navigated Transcranial Magnetic Stimulation Motor Mapping in Adjuvant Radiotherapy Planning in Patients With Supratentorial Brain Metastases. Front Oncol. 2018 Oct 2;8:424. doi: 10.3389/fonc.2018.00424. eCollection 2018. PMID 30333959
- BACKGROUNDStrnad V, Sauer R. [Prostatic carcinoma]. Dtsch Med Wochenschr. 1994 Jul 29;119(30):1054-6. No abstract available. German.