This study uses a cranial implant to deliver cortical stimulation that, when paired with physiotherapy, will remap the brain so that critical brain functions can be protected during brain tumor surgery. This pilot study will provide initial evidence for the safety and feasibility of such a protocol which will lead to future pivotal trials that could radically change eloquent area brain surgery. For patients with otherwise incompletely resectable brain tumors, this could mean a longer life expectancy and a better quality of life.
Age 18-65 years old
Ability to understand a written informed consent document, and the willingness to sign it
Radiographic evidence of likely low-grade glioma on MRI (i.e. non-enhancing) invading primary motor cortex in the non-dominant hemisphere.
Karnofsky performance status (KPS) ≥ 75
Presence of other malignancy not in remission
Evidence of bi-hemispheric or widespread tumor involvement
Likely candidate to receive GTR on initial resection
Medically high-risk surgical candidate
Single group
RNS System Implantation
DeviceFollowing resection consistent with SoC, if there is evidence of residual tumor which cannot be resected due to invasion of hand-M1 but which is small enough to be covered by two four-electrode strips, these strips will be placed on the functional cortex of interest and secured to the dura. The location of the leads will be registered into the navigation software (either Medtronic Stealth or Brainlab). The dura will then be closed as watertight as possible, and the RNS System will be incorporated into the craniotomy on closure Prior to closure, four bone screws will be placed and registered to the intraoperative navigation system as internal fiducials to be retrieved for future procedures.
Extent of resection
Calculated as: Tumor volume after second surgery - tumor volume before second surgery. Determination of volumes will be made by an attending radiologist without knowledge of clinical outcome. Manual segmentation will be performed to measure tumor volumes based on fluid-attenuated inversion recovery (FLAIR) axial slices.
Stimulation-induced motor deficits
Calculated as manual muscle score (MMS) before stimulation - MMS after stimulation. MMS is a zero-to-five scale assessed as the following: 5 - normal strength 4 - give away weakness 3 - movement against gravity 2 - movement in anti-gravity position 1 - muscle twitch 0 - no movement
Stimulation-induced language deficits
3a. Calculated as picture naming score (x/10) before stimulation minus after stimulation. 3b. Calculated as sentence repitition score (x/3) before stimulation minus after stimulation.
Stimulation-induced side effects
Reported as number of unintended stimulation effects, such as myoclonus, tonus, seizures, or unpleasant sensations
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