The Role of a Device to Evaluate the Neuromuscular Function in Assessing Muscle in Facial Paralysis Patients

Not Applicable

Completed

• Conditions: Facial Nerve Palsy
• Interventions: Device: MyotonPRO; Device: non-invasive electromyography (EMG)

• Registration Number: NCT02489162
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

The objective of the research is to determine whether the MyotonPRO has a valid and reliable application in facial, head and neck surgery. In addition, the study aims to compare this new technology with current electromyography.

Detailed Description

Facial paralysis has significant aesthetic, functional and psycho-social morbidity. The diagnosis and monitoring of neuromuscular recovery is limited to clinical examination, electromyography (EMG) and electroneurography (ENoG). EMG and ENoG is invasive for the patient and has practical and cost disadvantages. The MyotonPRO is a handheld device, which is pain-free and quick to use. Therefore this research is assessing MyotonPRO technology for this clinical application and may be effective at evaluating rehabilitative and surgical interventions. Phase 1 - Variation of measurements Phase 2 - Mimic muscle dysfunction assessment Phase 3 - Peri-operative Mimic and temporalis muscle assessment Phase 4 - Phase 3 including electromyography Phase 5 - Temporalis and mimic muscle assessment following facial reanimation surgery

Study Timeline

• Study First Submitted: 2015-06-10
• Study First Submitted QC: 2015-06-30
• Study First Posted: 2015-07-02
• Study Start: 2015-09
• Status Verified: 2018-10
• Primary Completion: 2018-12
• Study Completion: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. unilateral peripheral facial nerve palsy
2. Mental capacity to give consent
3. The patient is able to sit independently

Exclusion Criteria

1. Adults who have undertaken strenuous exercise within the last twenty-four hours
2. Adults taking prescription medication with a known effect on the mechanical properties of muscle (e.g. benzodiazepines) or receiving antispasmodic medications (e.g. botulinum A toxin)
3. Adults with poor mobility (unable to lie prone).
4. Adults with a body mass index (BMI) >30 kg/m2 . Muscle measurements may be inaccurate with excessive subcutaneous tissue

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-invasive electromyography (EMG)	non-invasive electromyography (EMG)	Comparing experimental intervention with gold standard
MyotonPRO	non-invasive electromyography (EMG)	Experimental: Measurement of biomechanical properties of mimic muscles on the ipsilateral palsy side with the healthy contralateral side ( case - control design)
Non-invasive electromyography (EMG)	MyotonPRO	Comparing experimental intervention with gold standard
MyotonPRO	MyotonPRO	Experimental: Measurement of biomechanical properties of mimic muscles on the ipsilateral palsy side with the healthy contralateral side ( case - control design)

Primary Outcome Measures

Name	Time	Method
Muscle tone (Hz)	12 months	Determine the feasibility of the MyotonPRO for assessing biomechanical properties of mimic muscles.

Secondary Outcome Measures

Name	Time	Method
stiffness (N/m)	12 months	Determine the feasibility of the MyotonPRO for assessing biomechanical properties of mimic muscles.

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Jette, Brussels, Belgium