Motor Eloquent Navigated Transcranial Magnetic Stimulation for Radiosurgery Planning

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInsel Gruppe AG, University Hospital Bern

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: MENTORExperimental treatment 1 intervention

Trial outcomes

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

Time frame
5 to 2 days before SRS

Secondary outcomes

1

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

Time frame
5 to 2 days before SRS
2

Target coverage (%) of both plans

Target coverage in %

Time frame
5 to 2 days before SRS
3

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

Time frame
At 3, 6 and 12 month follow-up
4

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

Time frame
At 3, 6 and 12 month follow-up

Other outcomes

Sponsors and contacts

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