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NCT04745156
A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade Gliomas
Conditions: Glioma, Glioma Intracranial, Gliomas Benign, Brain Tumor, Brain Cancer, Motor Cortex; Lesion
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 3
Sponsor: Medical College of Wisconsin
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT04745156). StuddyBuddy aggregates publicly available trial information.