A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade Gliomas

Launched by MEDICAL COLLEGE OF WISCONSIN · Feb 5, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring a new approach to help patients with low-grade gliomas, a type of brain tumor, during surgery. The study uses a special device that stimulates the brain while a patient also undergoes physical therapy. This combination aims to help the brain adjust, allowing surgeons to remove more of the tumor while protecting important brain functions. If successful, this method could lead to improved outcomes, meaning patients might live longer and have a better quality of life after surgery.

To participate in this trial, individuals need to be between 18 and 65 years old and show signs of a low-grade glioma on an MRI scan. They should also have good overall health and be able to understand and sign a consent form. However, certain conditions, like other active cancers or specific medical issues, may prevent someone from joining. The trial is not yet recruiting participants, but it represents an exciting opportunity for future advancements in brain tumor surgery.

Gender

ALL

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