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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04742231
Other study ID # 20-004730
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2020
Est. completion date December 2024

Study information

Verified date March 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Mayo Clinic Jacksonville Florida

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 Correlation Coefficient (?) 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
Secondary 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
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