Clinical trial · Interventional
Handheld Dynamometer During Awake Craniotomy Pilot
Use of Handheld Dynamometer As a Novel Tool to Assess Motor Function During Awake Craniotomy for Brain Lesions Located Within or Adjacent to the Motor Cortex: a Single-Center Pilot Study
NCT04742231CI-TRIAL-00086746completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 primary purpose of this study is to assess the feasibility, safety and reliability of the use of handheld dynamometry in evaluating intraoperative motor function for patients undergoing awake craniotomy for the resection of brain lesions located within or adjacent to the motor cortex.
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 Lesion | — | UNRESOLVED | — |
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Brain Tumor Adult | Brain Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hand-held dynamometer | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort 1. Patients with brain lesions in non-motor areas undergoing an awake craniotomy (AC)
- description
- 5 patient minimum
- interventionNames
- Device: Hand-held dynamometer
- type
- EXPERIMENTAL
- label
- Cohort 2. Patients with brain lesions within or proximal to motor areas undergoing an AC
- description
- 5 patient minimum
- interventionNames
- Device: Hand-held dynamometer
Primary outcomes (4)
- measure
- Intraoperative maximum grip strength (KgF) baseline
- timeFrame
- 1 day
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients ≥ 18 years old. * Primary or Recurrent Brain tumors * Single brain lesion * Lesion within or adjacent to the motor cortex- Lesion located within the primary or supplementary motor area (Verified by preoperative fMRI and DTI). Exclusion Criteria: * Patients \< 18 years old. * Major comorbidities (congestive heart failure, severe chronic obstructive pulmonary disease, morbid obesity, obstructive sleep apnea). * Patients with cognitive, intellectual or psychiatric impairment that could affect the capacity of following instructions evaluated during preoperative neuropsychological testing.
References
Publications (0)
Data not yet available
No reference posted for this study.