Status:
NOT_YET_RECRUITING
A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade Gliomas
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Glioma
Glioma Intracranial
Eligibility:
All Genders
18-65 years
Phase:
NA
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 surger...
Detailed Description
Study Protocol: Participants will undergo a standard-of-care craniotomy for resection of low-grade glioma. If part of the lesion cannot be removed due to involvement of functional cortex, RNS (Respons...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04745156
Start Date
August 1 2025
End Date
September 1 2027
Last Update
November 21 2024
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