A Study to Measure the Effect of Brain Stimulation on Hand Strength and Function in Patients With Brain Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intraoperative Brain Simulation - Alternate Stimulation Parameters.
- Who it may be relevant to
- Registry conditions: Brain Tumor, Brain Cancer, Motor Cortex; Lesion. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Intraoperative Cortical Stimulation on Hand Strength and Function During Awake Craniotomies
Overview
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]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
United States · 1 center
- Medical College of Wisconsin — Milwaukee
Identifiers
NCT: NCT05023434 · PRO00040251