A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Gra… (NCT04745156) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade Gliomas
3 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Extent of resection
Timeframe: Within 1 week after second surgery
2
Stimulation-induced motor deficits
Timeframe: Within 2 weeks after first surgery
3
Stimulation-induced language deficits
Timeframe: Within 2 weeks after first surgery
4
Stimulation-induced side effects
Timeframe: Within 2 weeks after first surgery
5
Safety of outpatient stimulation-therapy protocol
Timeframe: Up to 8 weeks
6
Stimulation-induced brain remapping
Timeframe: This data will be obtained intraoperatively during the second surgery
7
Number of participants with a new neurological deficit
Timeframe: Assessed at 3-month postoperative visit after second surgery