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Handheld Dynamometer During Awake Craniotomy Pilot

Primary Purpose

Brain Lesion, Brain Tumor Adult, Brain Tumor

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hand-held dynamometer
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Brain Lesion focused on measuring Awake Craniotomy, Dynamometer, Motor, Brain Mapping

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

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

Arm Description

5 patient minimum

5 patient minimum

Outcomes

Primary Outcome Measures

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.
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.
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]
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 16, 2020
Last Updated
December 22, 2022
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04742231
Brief Title
Handheld Dynamometer During Awake Craniotomy Pilot
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Lesion, Brain Tumor Adult, Brain Tumor
Keywords
Awake Craniotomy, Dynamometer, Motor, Brain Mapping

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1. Patients with brain lesions in non-motor areas undergoing an awake craniotomy (AC)
Arm Type
Experimental
Arm Description
5 patient minimum
Arm Title
Cohort 2. Patients with brain lesions within or proximal to motor areas undergoing an AC
Arm Type
Experimental
Arm Description
5 patient minimum
Intervention Type
Device
Intervention Name(s)
Hand-held dynamometer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intraoperative maximum grip strength (KgF) baseline
Description
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.
Time Frame
1 day
Title
Intraoperative maximum grip strength (KgF) variability
Description
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.
Time Frame
1 day
Title
Maximum grip strength (KgF) variability from preoperative baseline
Description
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]
Time Frame
1 day
Title
Operative Time (Minutes)
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Correlation Coefficient (ρ) between hand-held dynamometry and manual motor testing during AC
Description
Concordance between hand-held dynamometer and manual motor testing will be evaluated using Spearmans' correlation coefficient.
Time Frame
1 day
Title
Postoperative Maximum Grip Strength (KgF)
Description
Postoperative Maximum Grip strength (KgF) will be measured using hand-held dynamometer at day 1 and at 1 month follow-up.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaisorn Chaichana, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaisorn L Chaichana, M.D.
Phone
410-262-7828
Email
Chaichana.Kaisorn@mayo.edu
First Name & Middle Initial & Last Name & Degree
Lina C Marenco-Hillembrand, M.D.
Phone
9044228162
Email
marenco.lina@mayo.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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Handheld Dynamometer During Awake Craniotomy Pilot

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