Facial Function Reanimation by Electrical Pacing in Unilateral Facial Paralysis.
NCT ID: NCT03496025
Last Updated: 2020-12-19
Study Results
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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UNKNOWN
PHASE1
77 participants
INTERVENTIONAL
2015-08-01
2021-05-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Electrical stimulation
Electrical muscle stimulation
The intervention consists of activating paralyzed facial muscles with electrical stimulation.
Interventions
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Electrical muscle stimulation
The intervention consists of activating paralyzed facial muscles with electrical stimulation.
Eligibility Criteria
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Inclusion Criteria
* willingness to participate (patients, healthy volunteers)
Exclusion Criteria
* unstable cardiovascular disease
* severe immune deficiency
* other severe neurological diseases (causing cognitive or physical impairment)
* diabetic neuropathy
18 Years
75 Years
ALL
Yes
Sponsors
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Tampere University
OTHER
Tampere University of Technology
OTHER
Helsinki University Central Hospital
OTHER
Tampere University Hospital
OTHER
Responsible Party
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Principal Investigators
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Markus Rautiainen, MD, PhD
Role: STUDY_DIRECTOR
professor, head physician
Locations
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Tampere University Hospital
Tampere, , Finland
Countries
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References
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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.
Other Identifiers
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R15067
Identifier Type: -
Identifier Source: org_study_id