Handheld Dynamometer During Awake Craniotomy Pilot

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

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 Overview

• Status: Completed
• Conditions: Brain Tumor; Brain Tumor Adult; Brain Lesion
• Intervention / Treatment: Device: Hand-held dynamometer

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Kaisorn Chaichana, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): June 25, 2024
• Study Completion (Actual): June 25, 2024

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 28, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Dynamometer; Motor; Brain Mapping; Awake Craniotomy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: 20-004730

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No