Clinical trial NCT03496025: Facial Function Reanimation by Electrical Pacing in Unilateral Facial Paralysis.
Official title: Mimetic Interfaces - Toispuoleisen Kasvohermohalvauksen Kojeellinen Kuntoutus Terveen Puolen Lihasaktiviteettiohjauksella. Stimulaattorin Prototyypin Testaus terveillä koehenkilöillä ja Kasvohermohalvauspotilailla.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Facial Nerve Palsy
Keywords: facial nerve palsy
facial paralysis
functional electrical stimulation
facial pacing
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University
name: Tampere University of Technology
name: Helsinki University Central Hospital
First posted: 2018-04-12
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* malignant diseases (a previously treated cancer is not an exclusion criterion)
* unstable cardiovascular disease
* severe immune deficiency
* other severe neurological diseases (causing cognitive or physical impairment)
* diabetic neuropathy

Primary outcomes:
measure: Amplitudee of the movement elicited by electrical stimulation
timeFrame: Immediate
Secondary outcomes:
measure: Subjective ratings related to the tolerability of stimulations
timeFrame: Immediate
measure: Subjective ratings related to acceptability of the stimulated movement
timeFrame: Immediate
measure: Visual acuity
timeFrame: Immediate
measure: Changes in lacrimal fluid
timeFrame: Immediate
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: professor, head physician
name: Markus Rautiainen, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.