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Handheld Dynamometer During Awake Craniotomy Pilot

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ClinicalTrials.gov Identifier: NCT04742231
Recruitment Status : Recruiting
First Posted : February 8, 2021
Last Update Posted : December 23, 2021
Sponsor:
Information provided by (Responsible Party):
Kaisorn L. Chaichana, Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Brain Lesion Brain Tumor Adult Brain Tumor Device: Hand-held dynamometer Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: 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
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Intraoperative maximum grip strength (KgF) baseline [ Time Frame: 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.

  2. Intraoperative maximum grip strength (KgF) variability [ Time Frame: 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.

  3. Maximum grip strength (KgF) variability from preoperative baseline [ Time Frame: 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]

  4. Operative Time (Minutes) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Correlation Coefficient (ρ) between hand-held dynamometry and manual motor testing during AC [ Time Frame: 1 day ]
    Concordance between hand-held dynamometer and manual motor testing will be evaluated using Spearmans' correlation coefficient.

  2. Postoperative Maximum Grip Strength (KgF) [ Time Frame: 1 month ]
    Postoperative Maximum Grip strength (KgF) will be measured using hand-held dynamometer at day 1 and at 1 month follow-up.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04742231


Locations
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United States, Florida
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
Contact: Kaisorn L Chaichana, M.D.    410-262-7828    Chaichana.Kaisorn@mayo.edu   
Contact: Lina C Marenco-Hillembrand, M.D.    9044228162    marenco.lina@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Kaisorn Chaichana, MD Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Kaisorn L. Chaichana, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04742231    
Other Study ID Numbers: 20-004730
First Posted: February 8, 2021    Key Record Dates
Last Update Posted: December 23, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Kaisorn L. Chaichana, Mayo Clinic:
Awake Craniotomy
Dynamometer
Motor
Brain Mapping
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
 Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases