Status:
COMPLETED
Handheld Dynamometer During Awake Craniotomy Pilot
Lead Sponsor:
Mayo Clinic
Conditions:
Brain Lesion
Brain Tumor Adult
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 cran...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04742231
Start Date
July 1 2020
End Date
June 25 2024
Last Update
March 4 2025
Active Locations (1)
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1
Mayo Clinic
Jacksonville, Florida, United States, 32224