A Study to Measure the Effect of Brain Stimulation on Hand Strength and Function in Patients With Brain Tumors
Part of paid clinical trials in Milwaukee, Wisconsin.
- Sponsor
- Medical College of Wisconsin
- Study ID
- NCT05023434
- Status
- Recruiting
Conditions
- Brain Cancer
- Brain Tumor
- Motor Cortex; Lesion
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Accepted
Interventions
- Intraoperative Brain Simulation - Alternate Stimulation Parameters — PROCEDUREAdditional stimulation parameters outside of standard of care during intraoperative brain stimulation to aid in motor mapping.
Study Details
The neurosurgical standard of care for treating a patient with a tumor invading hand primary motor cortex (M1) includes performing a craniotomy with intraoperative direct electrical stimulation (DES) mapping and to resect as much tumor as possible without a resultant permanent neurological deficit. However, the subjective nature of current intraoperative hand motor assessments do not offer a comprehensive understanding of how hand strength and function may be impacted by resection. Additionally, there is a paucity of data to inform how altering DES parameters may effect motor mapping. Here, the investigators seek to demonstrate a feasible, standardized protocol to quantitatively assess hand strength and function and systematically assess several stimulation parameters to improve intraoperative measurements and better understand how cortical stimulation interacts with underlying neural function.
Key Dates
- Start date
- Apr 17, 2023
- Status verified
- May 2026
- Primary completion
- Dec 1, 2026
- Completion
- Dec 1, 2028
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DEVICE_FEASIBILITY
Arms
- Experimental: Awake Craniotomy
Primary Outcome Measure
Identify DES parameters that lead to either interruption or facilitation of hand movement during awake craniotomies [ Time Frame: Intra-op ]
Central Contacts
- Sarah Cornell414-955-0989
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 |
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