NCT05023434 · Medical College of Wisconsin
A Study to Measure the Effect of Brain Stimulation on Hand Strength and Function in Patients With Brain Tumors
What this study is about
The neurosurgical the usual treatment 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.
View original scientific description
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.
Interventions
PROCEDURE
Intraoperative Brain Simulation - Alternate Stimulation Parameters
Additional stimulation parameters outside of standard of care during intraoperative brain stimulation to aid in motor mapping.
Primary outcome measures
Identify DES parameters that lead to either interruption or facilitation of hand movement during awake craniotomies
Time frame: Intra-op
The categorization of stimulation frequencies (10, 30, 60, 130, and 250 Hz) as either inhibitory, facilitatory, or neutral, based on their impact on the finger individualization score.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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)
Where
- Milwaukee, Wisconsin
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
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Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 11, 2026 · Source of record for eligibility and locations