Handheld Dynamometer During Awake Craniotomy Pilot

Mayo Clinic

Status: Completed

Conditions: Brain Tumor; Brain Tumor Adult; Brain Lesion

Treatments: Device: Hand-held dynamometer

Study type: Interventional

Funder types: Other

Identifiers

NCT04742231

20-004730

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Cohort 1. Patients with brain lesions in non-motor areas undergoing an awake craniotomy (AC)

Experimental group

Description:

5 patient minimum

Treatment:

Device: Hand-held dynamometer

Cohort 2. Patients with brain lesions within or proximal to motor areas undergoing an AC

Experimental group

Description:

5 patient minimum

Treatment:

Device: Hand-held dynamometer