Recruiting

Brain Stimulation

Sponsor:

Medical College of Wisconsin

Code:

NCT05023434

Conditions

Brain Tumor

Brain Cancer

Motor Cortex; Lesion

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Intraoperative Brain Simulation - Alternate Stimulation Parameters

Study Details

Brief 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.

Conditions

Brain Tumor

Brain Cancer

Motor Cortex; Lesion

Study ID

NCT05023434

Start date

Apr 17, 2023

Status verified date

May, 2026

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Awake Craniotomy

Interventions

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 measure

  • Identify DES parameters that lead to either interruption or facilitation of hand movement during awake craniotomies [ Time Frame: Intra-op ]

Central Contacts and Locations

Central contacts

Sarah Cornell

414-955-0989scornell@mcw.edu

Locations

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Sarah Cornell

4149550989scornell@mcw.edu

More Information

Sponsor

Medical College of Wisconsin

Last update posted

May 11, 2026

Last verified

May, 2026

Keywords

  • Brain Stimulation
  • Cortex Stimulation
  • Hand Motor Cortex
  • Primary Motor Cortex
  • M1
  • Resection
  • Surgery
  • Healthy Volunteers
  • Hand Strength
  • Hand Function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-05-11.