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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age 18 - 75

• Ability to understand a written informed consent document, and the willingness to sign it

• Radiographic evidence of tumor on MRI (i.e. non-enhancing) invading primary motor cortex in the non-dominant hemisphere.

• Karnofsky performance status (KPS) ≥ 70

• Normal or near normal motor strength (i.e., at least 3/5 in relevant areas)

• Normal or near normal speech (Can consistently name at least 4/5 cards)

• Free of other illness, in the judgment of the investigator, that may shorten life expectancy

• Willing and able to participate in all aspects of the study

Locations
United States
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Sarah Cornell
scornell@mcw.edu
414-955-0989
Time Frame
Start Date: 2021-09-08
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 60
Treatments
Awake Craniotomy
Healthy Volunteers - No Longer Enrolling
Related Therapeutic Areas
Sponsors
Leads: Medical College of Wisconsin

This content was sourced from clinicaltrials.gov