RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-09-08
Study Completion:2026-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05023434

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 18 - 75
  2. 2. Ability to understand a written informed consent document, and the willingness to sign it
  3. 3. Radiographic evidence of tumor on MRI (i.e. non-enhancing) invading primary motor cortex in the non-dominant hemisphere.
  4. 4. Karnofsky performance status (KPS) ≥ 70
  5. 5. Normal or near normal motor strength (i.e., at least 3/5 in relevant areas)
  6. 6. Normal or near normal speech (Can consistently name at least 4/5 cards)
  7. 7. Free of other illness, in the judgment of the investigator, that may shorten life expectancy
  8. 8. Willing and able to participate in all aspects of the study
  1. 1. Presence of other malignancy not in remission
  2. 2. Evidence of bi-hemispheric or widespread tumor involvement
  3. 3. Medically high-risk surgical candidate
  4. 4. History of recent scalp or systemic infection
  5. 5. Presence of other implants or foreign bodies in the head
  6. 6. Inability to receive an MRI for any reason
  7. 7. Inability to receive cortical stimulation for any reason
  8. 8. Presence of implanted cardiac device (such as a pacemaker or defibrillator)

Contacts and Locations

Study Contact

Sarah Cornell
CONTACT
414-955-0989
scornell@mcw.edu

Study Locations (Sites)

Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Medical College of Wisconsin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-08
Study Completion Date2026-10-01

Study Record Updates

Study Start Date2021-09-08
Study Completion Date2026-10-01

Terms related to this study

Keywords Provided by Researchers

  • Brain Stimulation
  • Cortex Stimulation
  • Hand Motor Cortex
  • Primary Motor Cortex
  • M1
  • Resection
  • Surgery
  • Healthy Volunteers
  • Hand Strength
  • Hand Function

Additional Relevant MeSH Terms

  • Brain Tumor
  • Brain Cancer
  • Motor Cortex; Lesion