Clinical trial · Interventional
A Study to Measure the Effect of Brain Stimulation on Hand Strength and Function in Patients With Brain Tumors
The Effect of Intraoperative Cortical Stimulation on Hand Strength and Function During Awake Craniotomies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Cancer | Malignant Brain Neoplasm | ALIAS | 0.90 |
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Motor Cortex; Lesion | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraoperative Brain Simulation - Alternate Stimulation Parameters | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Awake Craniotomy
- interventionNames
- Procedure: Intraoperative Brain Simulation - Alternate Stimulation Parameters
Primary outcomes (1)
- measure
- Identify DES parameters that lead to either interruption or facilitation of hand movement during awake craniotomies
- timeFrame
- Intra-op
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available