Actively Recruiting
The Effect of Intraoperative Cortical Stimulation on Hand Strength and Function During Awake Craniotomies
Led by Medical College of Wisconsin · Updated on 2026-05-11
20
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new method to better understand how brain stimulation during awake craniotomies affects hand strength and function in patients with brain tumors invading the primary motor cortex. The study aims to improve the current standard of care, which involves brain surgery with electrical stimulation mapping to avoid permanent neurological damage. Investigators want to develop a standardized way to measure hand movement and explore different stimulation settings to see how they influence motor mapping. Participants will undergo awake craniotomy surgery where additional brain stimulation procedures with varying parameters will be tested beyond the usual care. This will help assess changes in hand strength and movement during the operation. The study focuses on patients with tumors affecting the non-dominant side of the brain's motor cortex. The intervention involves direct electrical stimulation applied during surgery to map motor function. During the study, participants will have their hand strength and function quantitatively measured while surgeons apply different stimulation settings. Researchers will monitor how these parameters interrupt or facilitate hand movement. Data collected will include motor strength assessments and functional tests during surgery to better understand brain stimulation effects. The study includes careful monitoring of neurological function throughout the procedure and will track outcomes related to hand movement during the craniotomy.
CONDITIONS
Brief Title
A Study to Measure the Effect of Brain Stimulation on Hand Strength and Function in Patients With Brain Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Ability to understand and sign a written informed consent document
- Radiographic evidence of tumor invading primary motor cortex on the non-dominant hemisphere
- Karnofsky performance status of 70 or higher
- Normal or near normal motor strength (at least 3 out of 5 in relevant areas)
- Normal or near normal speech (can consistently name at least 4 out of 5 cards)
- Free of other illnesses that may shorten life expectancy
- Willing and able to participate in all aspects of the study
You will not qualify if you...
- Presence of other malignancies not in remission
- Evidence of tumor involvement in both brain hemispheres or widespread tumor
- Medically high-risk for surgery
- Recent scalp or systemic infection
- Presence of implants or foreign bodies in the head
- Inability to have an MRI
- Inability to receive cortical stimulation
- Presence of implanted cardiac devices such as pacemakers or defibrillators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery and immediate recovery period
Participants undergo awake craniotomy surgery during which intraoperative brain stimulation with alternate parameters is applied to study hand movement effects.
1 surgical visit (in-person)
Trial Site Locations
Total: 1 location
1
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
S
Sarah Cornell
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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