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Facial Function Reanimation by Electrical Pacing in Unilateral Facial Paralysis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03496025
Recruitment Status : Active, not recruiting
First Posted : April 12, 2018
Last Update Posted : September 20, 2019
Sponsor:
Collaborators:
Tampere University
Tampere University of Technology
Helsinki University Central Hospital
Information provided by (Responsible Party):
Tampere University Hospital

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

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Study Type : Interventional  (Clinical Trial)
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 : August 1, 2015
Actual Primary Completion Date : October 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Amplitudee of the movement elicited by electrical stimulation [ Time Frame: 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 :
  1. Subjective ratings related to the tolerability of stimulations [ Time Frame: Immediate ]
    The participants evaluate the experienced discomfort and painfulness of the stimulation with a numeric rating scale (NRS).

  2. Subjective ratings related to acceptability of the stimulated movement [ Time Frame: Immediate ]
    The participants evaluate the naturalness and symmetry and their satisfaction with the stimulation elicited movement with an NRS.

  3. Visual acuity [ Time Frame: 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.

  4. Changes in lacrimal fluid [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496025


Locations
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Finland
Tampere University Hospital
Tampere, Finland, 33521
Sponsors and Collaborators
Tampere University Hospital
Tampere University
Tampere University of Technology
Helsinki University Central Hospital
Investigators
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Study Director: Markus Rautiainen, MD, PhD professor, head physician
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Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT03496025    
Other Study ID Numbers: R15067
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tampere University Hospital:
facial nerve palsy
facial paralysis
functional electrical stimulation
facial pacing
Additional relevant MeSH terms:
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Bell Palsy
Facial Paralysis
Facial Nerve Diseases
Facies
Disease Attributes
Pathologic Processes
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mouth Diseases
Stomatognathic Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Cranial Nerve Diseases