Handheld Dynamometer During Awake Craniotomy Pilot

Mayo Clinic10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Brain Lesion Brain Tumor Adult Brain Tumor

Interventions

Hand-held dynamometerDEVICE

Maximum Grip Strength will be measured using a hand-held dynamometer (K-FORCE Grip dynamometer®. Kinvent Biomequanique S.A.S, Montpellier, France) during the preoperative, intraoperative (Awake craniotomy) and postoperative period.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Intraoperative maximum grip strength (KgF) baseline

Maximum grip strength (KgF) will be measured using hand-held dynamometry every 2 minutes from the time the patient awakes until the end of surgery. Intraoperative maximum grip strength baseline is defined as the mean of 3 consecutive measures with \<10% variability.

Time frame: 1 day

Intraoperative maximum grip strength (KgF) variability

To validate the use of hand-held dynamometry as an adequate tool to monitor intraoperative motor function during awake craniotomies (AC), maximum grip strength (KgF) will be measured every 2 minutes from the time the patient awakes to the end of surgery. The intra-individual variability will be defined as the percent difference between sets with 10% or greater defined as substantial variability.

Time frame: 1 day

Maximum grip strength (KgF) variability from preoperative baseline

To validate the use of hand-held dynamometry as an adequate tool to monitor intraoperative motor function during AC, each patient will be baselined (mean of 6 consecutive measurements) during the preoperative neuropsychology evaluation. Variability from preoperative baseline will be calculated as a percentile \[ (Preoperative Baseline/ Intraoperative Baseline)/ Preoperative Baseline) \* 100\]

Time frame: 1 day

Operative Time (Minutes)

Defined as the duration of the procedure from the initiation of skin incision to the completion of skin closure according to anesthesia records. Measured in minutes.

Time frame: 1 day

Secondary Outcomes

Correlation Coefficient (ρ) between hand-held dynamometry and manual motor testing during AC

Concordance between hand-held dynamometer and manual motor testing will be evaluated using Spearmans' correlation coefficient.

Data from ClinicalTrials.gov

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