About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Intraoperative Brain Simulation - Alternate Stimulation Parameters
Procedure/SurgeryAdditional stimulation parameters outside of standard of care during intraoperative brain stimulation to aid in motor mapping.
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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