Home › Brain Tumors › 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

Who can join

Ages 18 to 75 · All sexes · Healthy volunteers welcome

AWAKE CRANIOTOMY COHORT

Inclusion Criteria:

1. Age 18 - 75
2. Ability to understand a written informed consent document, and the willingness to sign it
3. Radiographic evidence of tumor on MRI (i.e. non-enhancing) invading primary motor cortex in the non-dominant hemisphere.
4. Karnofsky performance status (KPS) ≥ 70
5. Normal or near normal motor strength (i.e., at least 3/5 in relevant areas)
6. Normal or near normal speech (Can consistently name at least 4/5 cards)
7. Free of other illness, in the judgment of the investigator, that may shorten life expectancy
8. Willing and able to participate in all aspects of the study

Exclusion Criteria:

1. Presence of other malignancy not in remission
2. Evidence of bi-hemispheric or widespread tumor involvement
3. Medically high-risk surgical candidate
4. History of recent scalp or systemic infection
5. Presence of other implants or foreign bodies in the head
6. Inability to receive an MRI for any reason
7. Inability to receive cortical stimulation for any reason
8. Presence of implanted cardiac device (such as a pacemaker or defibrillator)

About the study

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.

What is being tested

• Intraoperative Brain Simulation - Alternate Stimulation Parameters (procedure)

Sponsor: Medical College of Wisconsin · Participants: 20 · Started: Apr 17, 2023

Contact the study team

• Sarah Cornell · Phone: 414-955-0989

Official record on ClinicalTrials.gov — NCT05023434

Locations in the U.S.

Conditions

• Brain Tumors

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.