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

Brain Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05023434
• Other study ID #: PRO00040251
• Status: Recruiting
• Start date: September 8, 2021
• Est. completion date: October 1, 2024

Study information

• Verified date: February 2024
• Source: Medical College of Wisconsin
• Contact: Sarah Cornell
• Phone: 414-955-0989
• Email: scornell[@]mcw.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Brain Cancer
• Brain Neoplasms
• Brain Tumor
• Motor Cortex; Lesion

Intervention

Procedure:
• Intraoperative Brain Simulation - Alternate Stimulation Parameters
Additional stimulation parameters outside of standard of care during intraoperative brain stimulation to aid in motor mapping.

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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