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NCT Number: NCT05023434

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

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.

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Key information

Conditions

Brain Tumor Brain Cancer Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Motor Cortex; Lesion Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location status: Recruiting

Location contact

Sarah Cornell

CONTACT

[email protected]

4149550989

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

AWAKE CRANIOTOMY COHORT

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)

Treatment and study plan

Intraoperative Brain Simulation - Alternate Stimulation Parameters

Procedure

Additional stimulation parameters outside of standard of care during intraoperative brain stimulation to aid in motor mapping.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Cornell

CONTACT

[email protected]

414-955-0989

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

The Effect of Intraoperative Cortical Stimulation on Hand Strength and Function During Awake Craniotomies

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Aug 26, 2021
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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