About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- RNS System Implantation