Measuring brain stimulation effects on hand strength in brain tumor patients
The Effect of Intraoperative Cortical Stimulation on Hand Strength and Function During Awake Craniotomies
This study tests if brain stimulation during surgery can improve hand strength and function in patients with brain tumors affecting the part of the brain that controls movement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT05023434 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the impact of brain stimulation on hand strength and function in patients with brain tumors affecting the primary motor cortex. It involves a standardized protocol for intraoperative direct electrical stimulation (DES) mapping during awake craniotomy procedures. The researchers will assess various stimulation parameters to enhance the understanding of how these factors influence motor function and recovery. The goal is to provide a more objective measurement of hand strength and function post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with brain tumors invading the primary motor cortex and normal or near-normal motor strength.
Not a fit: Patients with widespread tumor involvement or other malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques that minimize neurological deficits and enhance recovery of hand function in brain tumor patients.
How similar studies have performed: While there is limited data on this specific approach, similar studies using brain stimulation techniques have shown promise in improving motor function in neurological patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Milwaukee, Wisconsin
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Sarah Cornell
- Email: scornell@mcw.edu
- Phone: 414-955-0989
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.