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

February 13, 2024 updated by: Max Krucoff, MD, Medical College of Wisconsin

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

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Healthy Volunteers - No Longer Enrolling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hand strength - Manual Motor Scale (0-5)
Time Frame: 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
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)
Time Frame: 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
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)
Time Frame: 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.
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)
Time Frame: 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.
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)
Time Frame: 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.
Pre-op, intra-op, 1 week post-op and 3 months post-op; 2 visits 3 weeks apart for healthy volunteers

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2021

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

October 1, 2024

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)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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