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

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Cancer; Brain Tumor; Motor Cortex; Lesion
• Intervention / Treatment: Procedure: Intraoperative Brain Simulation - Alternate Stimulation Parameters

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Cornell; Phone Number: 414-955-0989; Email: scornell@mcw.edu

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Medical College of Wisconsin
      • Contact: Sarah Cornell; Phone Number: 4149550989; Email: scornell@mcw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Study Population

Individuals with a clinical indication for an awake craniotomy with motor mapping.

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Awake Craniotomy	Procedure: Intraoperative Brain Simulation - Alternate Stimulation Parameters; Additional stimulation parameters outside of standard of care during intraoperative brain stimulation to aid in motor mapping.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify DES parameters that lead to either interruption or facilitation of hand movement during awake craniotomies	The categorization of stimulation frequencies (10, 30, 60, 130, and 250 Hz) as either inhibitory, facilitatory, or neutral, based on their impact on the finger individualization score.	Intra-op

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: August 20, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Surgery; Healthy Volunteers; Brain Stimulation; M1; Resection; Hand Function; Primary Motor Cortex; Hand Strength; Cortex Stimulation; Hand Motor Cortex
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: PRO00040251

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes