A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade Gliomas

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMedical College of Wisconsin

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

Treatment groups

3 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators