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

NCT04745156 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: PRO00039766
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Glioma; Glioma Intracranial; Gliomas Benign; Brain Tumor; Brain Cancer; Motor Cortex; Lesion

Keywords

Brain Stimulation; NeuroPace; Cortex Stimulation; Neuroplasticity; Plasticity; Hand Motor Cortex; Primary Motor Cortex; M1; Motor Mapping; Resection; Surgery; Motor Rehabilitation; Prehabilitation

Outcome Measures

Primary Outcomes (7)

• 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.

  Within 1 week after second surgery

• 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

  Within 2 weeks after first surgery

• 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.

  Within 2 weeks after first surgery

• Stimulation-induced side effects

  Reported as number of unintended stimulation effects, such as myoclonus, tonus, seizures, or unpleasant sensations

  Within 2 weeks after first surgery

• Safety of outpatient stimulation-therapy protocol

  Reported as number of stimulation- or physiotherapy related ER visits, readmissions, or serious adverse events

  Up to 8 weeks

• Stimulation-induced brain remapping

  This outcome will be reported as a descriptive variable, calculated as changes in the intraoperative stimulation map obtained during surgery 2 compared to surgery 1

  This data will be obtained intraoperatively during the second surgery

• Number of participants with a new neurological deficit

  Any new, permanent neurological deficits resulting from the second surgery

  Assessed at 3-month postoperative visit after second surgery

Study Arms (1)

RNS System Implantation

EXPERIMENTAL

This is a device feasibility study, therefore participants will only be enrolled into the investigational arm and will receive the RNS System Implantation.

Device: RNS System Implantation

Interventions

RNS System Implantation DEVICE

Following 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.

RNS System Implantation

Eligibility Criteria

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

You may qualify if:

• 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
• Normal or near normal motor strength (i.e., at least 3/5 in relevant areas)
• Normal or near normal speech (Can consistently name at least 4/5 cards)
• No medical contraindication to surgery
• Free of other illness that may shorten life expectancy

You may not qualify if:

• 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
• History of recent scalp or systemic infection
• Presence of other implants or foreign bodies in the head
• Inability to receive an MRI for any reason
• Inability to receive cortical stimulation for any reason
• Coagulation disorders and/or use of anti-thrombotic therapies
• Platelet count \< 50
• Diathermy procedures
• Electroconvulsive Therapy (ECT)
• Transcranial Magnetic Stimulation (TMS)
• Presence of implanted cardiac device (such as a pacemaker or defibrillator)
• Pregnant women

Sponsors & Collaborators

• Medical College of Wisconsin: lead

MeSH Terms

Conditions

Glioma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Max Krucoff, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Cornell

CONTACT

414-955-0989; scornell@mcw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurological Surgery

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 9, 2021
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01