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

Last updated: November 19, 2024
Sponsor: Medical College of Wisconsin
Overall Status: Active - Recruiting

Phase

N/A

Condition

Brain Cancer

Brain Tumor

Astrocytoma

Treatment

Intraoperative Brain Simulation - Alternate Stimulation Parameters

Clinical Study ID

NCT05023434
PRO00040251
  • Ages 18-75
  • All Genders

Study 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 Criteria

Inclusion

AWAKE CRANIOTOMY COHORT

Inclusion Criteria:

  1. Age 18 - 75

  2. Ability to understand a written informed consent document, and the willingness tosign it

  3. Radiographic evidence of tumor on MRI (i.e. non-enhancing) invading primary motorcortex 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 lifeexpectancy

  8. Willing and able to participate in all aspects of the study

Exclusion

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)

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Intraoperative Brain Simulation - Alternate Stimulation Parameters
Phase:
Study Start date:
September 08, 2021
Estimated Completion Date:
October 01, 2026

Connect with a study center

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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