A Study to Measure the Effect of Brain Stimulation on Hand Strength and Function in Patients with Brain Tumors

Launched by MEDICAL COLLEGE OF WISCONSIN · Aug 20, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how brain stimulation might improve hand strength and function in patients who have brain tumors that affect the part of the brain responsible for hand movement. During surgery, doctors will use a method called direct electrical stimulation to find out how the brain controls hand movements and to safely remove as much of the tumor as possible. The researchers want to create a reliable way to measure hand strength and find out how different stimulation settings can help better understand brain function during surgery.

To participate in this study, candidates must be between 18 and 75 years old and have a brain tumor located in the non-dominant side of the brain that affects movement. They should also be able to understand and sign consent forms and have a good level of physical and speech ability. Participants will be awake during the surgery, allowing them to respond to the stimulation tests, which will help doctors assess their hand function in real-time. This research aims to improve surgical techniques and outcomes for patients with brain tumors.

Gender

ALL

Eligibility criteria

• • AWAKE CRANIOTOMY COHORT
• Inclusion Criteria:
• • 1. Age 18 - 75
• • 2. Ability to understand a written informed consent document, and the willingness to sign it
• • 3. Radiographic evidence of tumor on MRI (i.e. non-enhancing) invading primary motor cortex in the non-dominant hemisphere.
• • 4. Karnofsky performance status (KPS) ≥ 70
• • 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. Free of other illness, in the judgment of the investigator, that may shorten life expectancy
• • 8. Willing and able to participate in all aspects of the study
• Exclusion Criteria:
• • 1. Presence of other malignancy not in remission
• • 2. Evidence of bi-hemispheric or widespread tumor involvement
• • 3. Medically high-risk surgical candidate
• • 4. History of recent scalp or systemic infection
• • 5. Presence of other implants or foreign bodies in the head
• • 6. Inability to receive an MRI for any reason
• • 7. Inability to receive cortical stimulation for any reason
• • 8. Presence of implanted cardiac device (such as a pacemaker or defibrillator)