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

Recruiting

• Conditions: Motor Cortex; Lesion; Brain Tumor; Brain Cancer
• Interventions: Procedure: Intraoperative Brain Simulation - Alternate Stimulation Parameters

• Registration Number: NCT05023434
• Lead Sponsor: Medical College of Wisconsin

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-30
• Study First Submitted QC: 2021-08-20
• Study First Posted: 2021-08-26
• Study Start: 2021-09-08
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21
• Primary Completion: 2026-08-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Awake Craniotomy	Intraoperative Brain Simulation - Alternate Stimulation Parameters	-

Primary Outcome Measures

Name	Time	Method
Change in Hand strength - Manual Motor Scale (0-5)	Pre-op, intra-op, 1 week post-op and 3 months post-op; 2 visits 3 weeks apart for healthy volunteers	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
Change in Hand strength - Dynamometer grip and pinch strength (Newtons)	Pre-op, intra-op, 1 week post-op and 3 months post-op; 2 visits 3 weeks apart for healthy volunteers	Scored using force production in kilograms (0-90) Standardized procedure for positioning
Chang in Hand function (Velocity)	Pre-op, intra-op, 1 week post-op and 3 months post-op; 2 visits 3 weeks apart for healthy volunteers	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.
Chang in Hand function (Finger Individuation)	Pre-op, intra-op, 1 week post-op and 3 months post-op; 2 visits 3 weeks apart for healthy volunteers	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.
Chang in Hand function (Smoothness)	Pre-op, intra-op, 1 week post-op and 3 months post-op; 2 visits 3 weeks apart for healthy volunteers	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.

Trial Locations

Locations (1)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States