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

NCT05023434 | Active Not Recruiting

• 1 other identifier: PRO00040251
• Study Type: observational
• Target: 60
• 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 (5)

• Change in Hand strength - Manual Motor Scale (0-5)

  Quantitative assessment on a scale of 0 - 5 5 - normal strength 4 - give away weakness 3 - movement against gravity 2 - movement in anti-gravity position 1 - muscle twitch 0 - no movement

  Pre-op, intra-op, 1 week post-op and 3 months post-op; 2 visits 3 weeks apart for healthy volunteers

• Change in Hand strength - Dynamometer grip and pinch strength (Newtons)

  Scored using force production in kilograms (0-90) Standardized procedure for positioning

  Pre-op, intra-op, 1 week post-op and 3 months post-op; 2 visits 3 weeks apart for healthy volunteers

• Chang in Hand function (Velocity)

  The Cyberglove III collects data on the movement of the joints in the hand. Subjects will be asked to wear the Cyberglove III while doing various tasks. Velocity will be measured in degrees per second.

  Pre-op, intra-op, 1 week post-op and 3 months post-op; 2 visits 3 weeks apart for healthy volunteers

• Chang in Hand function (Finger Individuation)

  The Cyberglove III collects data on the movement of the joints in the hand. Subjects will be asked to wear the Cyberglove III while doing various tasks. Finger individuation will be calculated using joint angles.

  Pre-op, intra-op, 1 week post-op and 3 months post-op; 2 visits 3 weeks apart for healthy volunteers

• Chang in Hand function (Smoothness)

  The Cyberglove III collects data on the movement of the joints in the hand. Subjects will be asked to wear the Cyberglove III while doing various tasks. Smoothness will be calculated using joint angles.

  Pre-op, intra-op, 1 week post-op and 3 months post-op; 2 visits 3 weeks apart for healthy volunteers

Study Arms (2)

Awake Craniotomy

Procedure: Intraoperative Brain Simulation - Alternate Stimulation Parameters

Healthy Volunteers - No Longer Enrolling

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: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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

Location

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• 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: September 8, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)