Clinical trial · Interventional
A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade Gliomas
Inducing Functional Plasticity in Glioma-Involved Functional Cortex With Deficit-Inducing Cortical Stimulation and Targeted Behavioral Therapy to Increase Extent of Resection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Cancer | Malignant Brain Neoplasm | ALIAS | 0.90 |
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
| Glioma Intracranial | — | UNRESOLVED | — |
| Gliomas Benign | — | UNRESOLVED | — |
| Motor Cortex; Lesion | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RNS System Implantation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RNS System Implantation
- description
- This is a device feasibility study, therefore participants will only be enrolled into the investigational arm and will receive the RNS System Implantation.
- interventionNames
- Device: RNS System Implantation
Primary outcomes (7)
- measure
- Extent of resection
- timeFrame
- Within 1 week after second surgery
- description
- 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.
- measure
- Stimulation-induced motor deficits
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-65 years old 2. Ability to understand a written informed consent document, and the willingness to sign it 3. Radiographic evidence of likely low-grade glioma on MRI (i.e. non-enhancing) invading primary motor cortex in the non-dominant hemisphere. 4. Karnofsky performance status (KPS) ≥ 75 5. Normal or near normal motor strength (i.e., at least 3/5 in relevant areas) 6. Normal or near normal speech (Can consistently name at least 4/5 cards) 7. No medical contraindication to surgery 8. Free of other illness that may shorten life expectancy Exclusion Criteria: 1. Presence of other malignancy not in remission 2. Evidence of bi-hemispheric or widespread tumor involvement 3. Likely candidate to receive GTR on initial resection 4. Medically high-risk surgical candidate 5. History of recent scalp or systemic infection 6. Presence of other implants or foreign bodies in the head 7. Inability to receive an MRI for any reason 8. Inability to receive cortical stimulation for any reason 9. Coagulation disorders and/or use of anti-thrombotic therapies 10. Platelet count \< 50 11. Diathermy procedures 12. Electroconvulsive Therapy (ECT) 13. Transcranial Magnetic Stimulation (TMS) 14. Presence of implanted cardiac device (such as a pacemaker or defibrillator) 15. Pregnant women
References
Publications (0)
Data not yet available