Handheld Dynamometer During Awake Craniotomy Pilot

Not Applicable

Recruiting

• Conditions: Brain Lesion; Brain Tumor Adult; Brain Tumor
• Interventions: Device: Hand-held dynamometer

• Registration Number: NCT04742231
• Lead Sponsor: Mayo Clinic

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 craniotomy for the resection of brain lesions located within or adjacent to the motor cortex.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2020-12-16
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-22
• Last Update Posted: 2024-03-25
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1. Patients with brain lesions in non-motor areas undergoing an awake craniotomy (AC)	Hand-held dynamometer	5 patient minimum
Cohort 2. Patients with brain lesions within or proximal to motor areas undergoing an AC	Hand-held dynamometer	5 patient minimum

Primary Outcome Measures

Name	Time	Method
Maximum grip strength (KgF) variability from preoperative baseline	1 day	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 \[ (Preoperative Baseline/ Intraoperative Baseline)/ Preoperative Baseline) \* 100\]
Operative Time (Minutes)	1 day	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.
Intraoperative maximum grip strength (KgF) baseline	1 day	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.
Intraoperative maximum grip strength (KgF) variability	1 day	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.

Secondary Outcome Measures

Name	Time	Method
Correlation Coefficient (ρ) between hand-held dynamometry and manual motor testing during AC	1 day	Concordance between hand-held dynamometer and manual motor testing will be evaluated using Spearmans' correlation coefficient.
Postoperative Maximum Grip Strength (KgF)	1 month	Postoperative Maximum Grip strength (KgF) will be measured using hand-held dynamometer at day 1 and at 1 month follow-up.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States