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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Intraoperative Brain Simulation - Alternate Stimulation Parameters — PROCEDURE
    Additional 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

Locations (1)

FacilityCityStateZIPSite coordinators
Medical College of WisconsinMilwaukeeWisconsin53226
Sarah Cornell
4149550989

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