Motor Eloquent Navigated Transcranial Magnetic Stimulation for Radiosurgery Planning

NCT07415668 | Recruiting

• 1 other identifier: MENTOR
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Metastases to Brain

Keywords

metastasis; Navigated Transcranial Magnetic Stimulation (nTMS); Stereotactic Radiosurgery (SRS)

Outcome Measures

Primary Outcomes (1)

• 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

  5 to 2 days before SRS

Secondary Outcomes (9)

• Feasibility of plan selection

  5 to 2 days before SRS

• Target coverage (%) of both plans

  5 to 2 days before SRS

• Motor outcome

  At 3, 6 and 12 month follow-up

• Motor outcome

  At 3, 6 and 12 month follow-up

• Motor outcome

  At 3, 6 and 12 month follow-up

Study Arms (1)

MENTOR

EXPERIMENTAL

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.

Device: Navigated Transcranial Magnetic Stimulation (nTMS)

Interventions

Navigated Transcranial Magnetic Stimulation (nTMS) DEVICE

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.

MENTOR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent
• Age ≥ 18 years
• Cerebral metastasis within or adjacent to the primary motor cortex (≤10 mm)
• Resection of tumor
• Eligible for and planned to undergo postresection radiosurgery at Inselspital Bern

You may not qualify if:

• 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
• Pregnancy

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

University Hostpital Bern, Department of Neurosurgery Bern

Bern, 3010, Switzerland

RECRUITING

Related Publications (10)

• Milano 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 BACKGROUND

• Kondziolka 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 BACKGROUND

• Lin 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 BACKGROUND

• Rossi 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 BACKGROUND

• Schwendner 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 BACKGROUND

• Strnad V, Sauer R. [Prostatic carcinoma]. Dtsch Med Wochenschr. 1994 Jul 29;119(30):1054-6. No abstract available. German.

  PMID: 8050345 BACKGROUND

• Kamada K, Todo T, Masutani Y, Aoki S, Ino K, Takano T, Kirino T, Kawahara N, Morita A. Combined use of tractography-integrated functional neuronavigation and direct fiber stimulation. J Neurosurg. 2005 Apr;102(4):664-72. doi: 10.3171/jns.2005.102.4.0664.

  PMID: 15871509 BACKGROUND

• Scoccianti S, Detti B, Gadda D, Greto D, Furfaro I, Meacci F, Simontacchi G, Di Brina L, Bonomo P, Giacomelli I, Meattini I, Mangoni M, Cappelli S, Cassani S, Talamonti C, Bordi L, Livi L. Organs at risk in the brain and their dose-constraints in adults and in children: a radiation oncologist's guide for delineation in everyday practice. Radiother Oncol. 2015 Feb;114(2):230-8. doi: 10.1016/j.radonc.2015.01.016. Epub 2015 Feb 17.

  PMID: 25701297 BACKGROUND

• Hodapp N. [The ICRU Report 83: prescribing, recording and reporting photon-beam intensity-modulated radiation therapy (IMRT)]. Strahlenther Onkol. 2012 Jan;188(1):97-9. doi: 10.1007/s00066-011-0015-x. No abstract available. German.

  PMID: 22234506 BACKGROUND

• Seidel K, Hani L, Lutz K, Zbinden C, Redmann A, Consuegra A, Raabe A, Schucht P. Postoperative navigated transcranial magnetic stimulation to predict motor recovery after surgery of tumors in motor eloquent areas. Clin Neurophysiol. 2019 Jun;130(6):952-959. doi: 10.1016/j.clinph.2019.03.015. Epub 2019 Apr 5.

  PMID: 30981901 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Brain Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 17, 2026
• Study Start: May 8, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): October 31, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)