Facial Function Reanimation by Electrical Pacing in Unilateral Facial Paralysis.

Sponsor

Tampere University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03496025

Collaborator

Tampere University (Other), Tampere University of Technology (Other), Helsinki University Central Hospital (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Facial Nerve Palsy	Device: Electrical muscle stimulation	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

77 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Mimetic Interfaces - Toispuoleisen Kasvohermohalvauksen Kojeellinen Kuntoutus Terveen Puolen Lihasaktiviteettiohjauksella. Stimulaattorin Prototyypin Testaus terveillä koehenkilöillä ja Kasvohermohalvauspotilailla.

Actual Study Start Date :

Aug 1, 2015

Actual Primary Completion Date :

Oct 31, 2018

Anticipated Study Completion Date :

May 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Electrical stimulation	Device: Electrical muscle stimulation The intervention consists of activating paralyzed facial muscles with electrical stimulation.

Arm

Intervention/Treatment

Experimental: Electrical stimulation

Device: Electrical muscle stimulation

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

Outcome Measures

Primary Outcome Measures

Amplitudee of the movement elicited by electrical stimulation [Immediate]
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.

Secondary Outcome Measures

Subjective ratings related to the tolerability of stimulations [Immediate]
The participants evaluate the experienced discomfort and painfulness of the stimulation with a numeric rating scale (NRS).
Subjective ratings related to acceptability of the stimulated movement [Immediate]
The participants evaluate the naturalness and symmetry and their satisfaction with the stimulation elicited movement with an NRS.
Visual acuity [Immediate]
In substudies concerning the elicitation of eye blink, The visual acuity is measured for both eyes separately with a LogMAR chart before and after the stimulation session.
Changes in lacrimal fluid [Immediate]
In substudies concerning the elicitation of eye blink, a lacrimal fluid sample is collected before and after the stimulation session to investigate the possible effects of the stimulation in its constitution.