Brain Lesion, Brain Tumor, Brain Tumor Adult
Conditions
Keywords
Awake Craniotomy, Dynamometer, Motor, Brain Mapping
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.
Interventions
DEVICEHand-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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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 \[ (Preoperative Baseline/ Intraoperative Baseline)/ Preoperative Baseline) \* 100\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed