Handheld Dynamometer During Awake Craniotomy Pilot

NCT04742231 | Completed FDA Device

• 1 other identifier: 20-004730
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Lesion; Brain Tumor Adult; Brain Tumor

Keywords

Awake Craniotomy; Dynamometer; Motor; Brain Mapping

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

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

  1 day

• Postoperative Maximum Grip Strength (KgF)

  1 month

Study Arms (2)

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

EXPERIMENTAL

5 patient minimum

Device: Hand-held dynamometer

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

EXPERIMENTAL

5 patient minimum

Device: Hand-held dynamometer

Interventions

Hand-held dynamometer DEVICE

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.

Cohort 1. Patients with brain lesions in non-motor areas undergoing an awake craniotomy (AC); Cohort 2. Patients with brain lesions within or proximal to motor areas undergoing an AC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Kaisorn Chaichana, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: February 8, 2021
• Study Start: July 1, 2020
• Primary Completion: June 25, 2024
• Study Completion: June 25, 2024
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)