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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1. Patients with brain lesions in non-motor areas undergoing an awake craniotomy (AC) | Experimental | 5 patient minimum |
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| Cohort 2. Patients with brain lesions within or proximal to motor areas undergoing an AC | Experimental | 5 patient minimum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
| Postoperative Maximum Grip Strength (KgF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kaisorn Chaichana, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Postoperative Maximum Grip strength (KgF) will be measured using hand-held dynamometer at day 1 and at 1 month follow-up. |
| 1 month |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |