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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines brain stimulation with behavioral therapy before surgery to try to increase how much of the tumor can be safely removed — is my tumor's location near the motor or language areas of my brain in a way that might make this approach relevant to my situation?
2The trial is listed as 'not yet recruiting,' so is there a realistic timeline for when it might open, and would waiting for it potentially affect my treatment options if I need surgery sooner?
3One of the key things being measured is whether the stimulation causes new motor or language deficits — given what you know about my tumor, how do you assess my personal risk of those side effects compared to standard surgical planning?
4The study involves outpatient stimulation and therapy sessions before the actual surgery — can you help me understand what that schedule would realistically look like in terms of time commitment and travel, and whether my current health would allow for that kind of protocol?
5Since this is a Phase NA / early-stage study primarily measuring safety and whether the brain can 'remap' itself, how does the level of evidence here compare to what's already known about standard surgical approaches for low-grade gliomas, and is there a conventional option we should consider first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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