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

NCT05023434 | Recruiting DMC

• 1 other identifier: PRO00040251
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor; Brain Cancer; Motor Cortex; Lesion

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Awake Craniotomy

EXPERIMENTAL

Procedure: Intraoperative Brain Simulation - Alternate Stimulation Parameters

Interventions

Intraoperative Brain Simulation - Alternate Stimulation Parameters PROCEDURE

Additional stimulation parameters outside of standard of care during intraoperative brain stimulation to aid in motor mapping.

Awake Craniotomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Sarah Cornell

CONTACT

414-955-0989; scornell@mcw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurological Surgery

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: August 26, 2021
• Study Start: April 17, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)