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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMedical College of Wisconsin

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Intraoperative Brain Simulation - Alternate Stimulation Parameters

    Procedure/Surgery

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Awake CraniotomyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Intra-op

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.