Brain TumorNCT05023434
A Study to Measure the Effect of Brain Stimulation on Hand Strength and Function in Patients With Brain Tumors
A study testing Intraoperative Brain Simulation - Alternate Stimulation Parameters in people with Brain Tumor and Brain Cancer, run by Medical College of Wisconsin at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Tumor, Brain Cancer, Motor Cortex; Lesion
- What is being tested?
- Intraoperative Brain Simulation - Alternate Stimulation Parameters
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2023to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Sarah Cornell, 4149550989, scornell@mcw.edu
About this study
Official title: 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.
- Conditions
- Brain Tumor, Brain Cancer, Motor Cortex; Lesion
- Being tested
- Intraoperative Brain Simulation - Alternate Stimulation Parameters
- Keywords
- Brain Stimulation, Cortex Stimulation, Hand Motor Cortex, Primary Motor Cortex, M1, Resection, Surgery, Healthy Volunteers, Hand Strength, Hand Function
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Brain Simulation - Alternate Stimulation ParametersProcedure or surgery
Additional stimulation parameters outside of standard of care during intraoperative brain stimulation to aid in motor mapping.
| Study group | Role | What they receive |
|---|---|---|
| Awake Craniotomy | Experimental | Not described Receives: Procedure: Intraoperative Brain Simulation - Alternate Stimulation Parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify DES parameters that lead to either interruption or facilitation of hand movement during awake craniotomies
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.
Measured: Intra-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start17 Apr 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Max Krucoff, MD, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023434
- Sponsor's protocol ID
- PRO00040251
- Status last verified
- May 2026
- First submitted
- 30 Jun 2021
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Cortical Stimulation on Hand Strength and Function During Awake Craniotomies
- ClinicalTrials.gov ID
- NCT05023434
- Acronym / sponsor ID
- PRO00040251
- Conditions
- Brain Tumor, Brain Cancer, Motor Cortex; Lesion
- Keywords
- Brain Stimulation, Cortex Stimulation, Hand Motor Cortex, Primary Motor Cortex, M1, Resection, Surgery, Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 26 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Awake Craniotomy | Experimental | Procedure: Intraoperative Brain Simulation - Alternate Stimulation Parameters |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative Brain Simulation - Alternate Stimulation ParametersAdditional stimulation parameters outside of standard of care during intraoperative brain stimulation to aid in motor mapping. | Procedure or surgery | Awake Craniotomy |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative Brain Simulation - Alternate Stimulation Parameters in people with Brain Tumor and Brain Cancer, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaitlin Goetschel (414-955-7398, kgoetschel@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify DES parameters that lead to either interruption or facilitation of hand movement during awake craniotomies (time frame: Intra-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.