Handheld Dynamometer During Awake Craniotomy Pilot

• Sponsor: Mayo Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04742231
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 30
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Lesion; Brain Tumor Adult; Brain Tumor	Device: Hand-held dynamometer	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Jul 1, 2020
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

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

Primary Outcome Measures

1. Intraoperative maximum grip strength (KgF) baseline [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 [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 [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) [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 [1 day]

   Concordance between hand-held dynamometer and manual motor testing will be evaluated using Spearmans' correlation coefficient.

2. Postoperative Maximum Grip Strength (KgF) [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Jacksonville	Florida	United States	32224

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Kaisorn Chaichana, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Kaisorn L. Chaichana, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT04742231
• Other Study ID Numbers: 20-004730
• First Posted: Feb 8, 2021
• Last Update Posted: Dec 23, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Kaisorn L. Chaichana, Principal Investigator, Mayo Clinic: Awake Craniotomy; Dynamometer; Motor; Brain Mapping
• Additional relevant MeSH terms: Brain Neoplasms

Study Results

No Results Posted as of Dec 23, 2021