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NCT05023434 | RECRUITING | Brain Tumor

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

Medical College of Wisconsin

Information provided by (Responsible Party):

Max Krucoff, MD

Brief 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.

Condition or disease

Brain Tumor

Brain Cancer

Motor Cortex; Lesion

Intervention/treatment

Intraoperative Brain Simulation - Alternate Stimulation Parameters

Study Type : OBSERVATIONAL
Estimated Enrollment : 60 participants
Official Title : The Effect of Intraoperative Cortical Stimulation on Hand Strength and Function During Awake Craniotomies
Actual Study Start Date : 2021-09-08
Estimated Primary Completion Date : 2026-08-01
Estimated Study Completion Date : 2026-10-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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)
    • A Study to Measure the Effect of Brain Stimulation on Hand Strength and Function in Patients with Brain Tumors

    Location Details

    NCT05023434

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    Locations

    RECRUITING

    United States, Wisconsin

    Medical College of Wisconsin

    Milwaukee, Wisconsin, United States, 53226