Handheld Dynamometer During Awake Craniotomy Pilot

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2024-06-25

Brief Summary

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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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Detailed Description

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Conditions

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Brain Lesion Brain Tumor Adult Brain Tumor

Study Design

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Allocation Method

NA

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Cohort 1. Patients with brain lesions in non-motor areas undergoing an awake craniotomy (AC)

5 patient minimum

Group Type EXPERIMENTAL

Hand-held dynamometer

Intervention Type 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.

Cohort 2. Patients with brain lesions within or proximal to motor areas undergoing an AC

5 patient minimum

Group Type EXPERIMENTAL

Hand-held dynamometer

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No