Facial Function Reanimation by Electrical Pacing in Unilateral Facial Paralysis.

NCT03496025 | Unknown Phase 1

• 1 other identifier: R15067
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose of the trial is to study the activations of paralyzed facial muscles in a unilateral facial nerve palsy with a multi-channel electrical stimulator. The principle of the device is to measure muscle activity of the healthy side of the face by surface electromyography (EMG) and to use this information to stimulate the corresponding muscles of the paralyzed side. The ultimate goal is to develop a prosthetic device for persons with a facial nerve palsy. The trial consists of several different studies. The studies' aims are 1. To study activations of paralyzed facial muscles by the electrical stimulation. 2. To study different stimulation pulse waveforms, frequencies, and electrode placement and their effect on the muscle activations and the tolerability of the stimulation. 3. To study whether a symmetrical movement on the paralyzed side can be achieved with electrical stimulation when compared to the movements of the healthy side. 4. To study tolerability of stimulation-elicited eye blink when watching a film and the effect of the stimulation-induced blink on the eye symptoms, the visual acuity, and the effects of the stimulation on the lacrimal fluid. 5. To develop a method for facial pacing, i.e. measuring the muscle activations on the healthy side of the face and to use this information to stimulate and activate the healthy side of the face. Forty subjects with a chronic facial nerve palsy are recruited to the studies. Each subject can participate in one or several studies. Another forty subjects with an acute facial nerve palsy are recruited to the study on the tolerability and effect on the eye symptoms. Additionally, altogether ninety healthy volunteers are recruited to the studies in order to gather preliminary information on the tolerability and the effects of the stimulations.

Conditions

Facial Nerve Palsy

Keywords

facial nerve palsy; facial paralysis; functional electrical stimulation; facial pacing

Outcome Measures

Primary Outcomes (1)

• Amplitudee of the movement elicited by electrical stimulation

  The offline video analysis is done to determine the current threshold at which a movement of the target muscle is produced. Possible activations of the other muscles alongside the target muscle are also observed. The amplitude of the movement is analyzed offline from a video recording either visually by the investigators, or measured with a digital ruler. With visual evaluation, the outcome is measured on a rough level, i.e. whether the stimulated movement was larger in amplitude compared to the voluntary movement. With a digital ruler, the results a presented numerically (millimeters). The stimulated activation is compared to the voluntary activation of the muscle. Further, in some sub-studies, the facial activations are evaluated with the Facial Action Coding System.

  Immediate

Secondary Outcomes (4)

• Subjective ratings related to the tolerability of stimulations

  Immediate

• Subjective ratings related to acceptability of the stimulated movement

  Immediate

• Visual acuity

  Immediate

• Changes in lacrimal fluid

  Immediate

Study Arms (1)

Electrical stimulation

EXPERIMENTAL

Device: Electrical muscle stimulation

Interventions

Electrical muscle stimulation DEVICE

The intervention consists of activating paralyzed facial muscles with electrical stimulation.

Electrical stimulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a unilateral peripheral facial nerve palsy (patients)
• willingness to participate (patients, healthy volunteers)

You may not qualify if:

• unstable cardiovascular disease
• severe immune deficiency
• other severe neurological diseases (causing cognitive or physical impairment)
• diabetic neuropathy

Sponsors & Collaborators

• Tampere University Hospital: lead
• Tampere University: collaborator
• Tampere University of Technology: collaborator
• Helsinki University Central Hospital: collaborator

Study Sites (1)

Tampere University Hospital

Tampere, 33521, Finland

Location

Related Publications (1)

• Makela EA, Ilves MK, Venesvirta HM, Lylykangas JK, Rantanen VT, Vehkaoja AT, Verho JA, Lekkala J, Surakka VV, Rautiainen MEP. Effect of pulse waveforms on movement amplitudes and perceived discomfort in electric muscle stimulation in unresolved facial nerve palsy. Biomed Phys Eng Express. 2020 Mar 25;6(3):035013. doi: 10.1088/2057-1976/ab7eea.

  PMID: 33438658 DERIVED

MeSH Terms

Conditions

Bell Palsy; Facial Paralysis

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Mouth Diseases; Stomatognathic Diseases; Facial Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Markus Rautiainen, MD, PhD

  professor, head physician

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: April 12, 2018
• Study Start: August 1, 2015
• Primary Completion: October 31, 2018
• Study Completion: May 31, 2021
• Last Updated: December 19, 2020

Record last verified: 2019-09

Locations

FI (1)