A Phase 1 interventional study of Electrical muscle stimulation in Facial Nerve Palsy, sponsored by Tampere University Hospital. Status unknown at 1 site in Finland. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-19.
Sponsored by Tampere University Hospital · Phase 1, Interventional, and Treatment
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.
85 studies on the registry are indexed under Bell Palsy; 30 are open to participants now.
This study's enrollment of 77 is above the median of 42 across 70 interventional studies indexed under Bell Palsy.
Browse Bell Palsy studies →Tampere University Hospital is the lead sponsor of 212 studies on the registry; 56 are open to participants now.
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Device: Electrical muscle stimulation
The intervention consists of activating paralyzed facial muscles with electrical stimulation.
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.
Time frame: Immediate
Subjective ratings related to the tolerability of stimulations
The participants evaluate the experienced discomfort and painfulness of the stimulation with a numeric rating scale (NRS).
Time frame: Immediate
Subjective ratings related to acceptability of the stimulated movement
The participants evaluate the naturalness and symmetry and their satisfaction with the stimulation elicited movement with an NRS.
Time frame: Immediate
Visual acuity
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.
Time frame: Immediate
Changes in lacrimal fluid
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.
Time frame: Immediate
Ran from Aug 2015 to primary completion in Oct 2018, 38 months.
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This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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