NCT05023434

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

The Effect of Intraoperative Cortical Stimulation on Hand Strength and Function During Awake Craniotomies

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Brain Tumor
• Brain Cancer
• Motor Cortex; Lesion

Interventions

Type	Name	Description
PROCEDURE	Intraoperative Brain Simulation - Alternate Stimulation Parameters	Additional stimulation parameters outside of standard of care during intraoperative brain stimulation to aid in motor mapping.

Timeline

• Start date: 2021-09-08
• Primary completion: 2026-08-01
• Completion: 2026-10-01
• First posted: 2021-08-26
• Last updated: 2026-01-12

Locations

1 site across 1 country: United States