Handheld Dynamometer During Awake Craniotomy Pilot

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Brain Lesion, Brain Tumor Adult, Brain Tumor

Intervention / Treatment
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* Device: Hand-held dynamometer


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1. Patients with brain lesions in non-motor areas undergoing an awake craniotomy (AC)<br>5 patient minimum | Device: Hand-held dynamometer<br>* 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.<br>|
| Experimental: Cohort 2. Patients with brain lesions within or proximal to motor areas undergoing an AC<br>5 patient minimum | Device: Hand-held dynamometer<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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] | 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 day | 
| Postoperative Maximum Grip Strength (KgF) | Postoperative Maximum Grip strength (KgF) will be measured using hand-held dynamometer at day 1 and at 1 month follow-up. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Awake Craniotomy, Dynamometer, Motor, Brain Mapping