Condition category
Nervous System Diseases
Date applied
16/10/2020
Date assigned
25/11/2020
Last edited
25/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Bell's palsy is a weakness or lack of movement affecting one side of the face. The aim of this study is to assess the feasibility of a future larger study on the Mirror Effect therapy for patients with Bell’s palsy. Most patients with Bell’s palsy recover completely. However, symptoms might persist over time, which often result in facial deformity and reduced mouth mobility. Therefore, people with such symptoms might experience changes in swallowing and speaking, which could impact their quality of life and self-esteem. In the present study, the researchers are assessing the impacts of early speech therapy on overall recovery and prevention of complications, called facial synkinesis. Synkinesis is defined as involuntary facial movements that occur while attempting to move another part of the face. This study is recruiting a small number of patients to be able to obtain an estimate of the effectiveness of the new therapy called the Mirror Effect Plus Protocol (MEPP). The MEPP will be combined with general recommendations given by the speech therapist and pharmaceutical treatment currently provided in Quebec. The researchers will compare this treatment to the usual course of treatment in Quebec, which is general recommendations given by the speech therapist and traditional pharmaceutical treatment. A positive outcome will lead to a larger study to assess the efficacy of the MEPP.

Who can participate?
Patients aged 18 and over with acute and severe Bell's palsy

What does the study involve?
Participants are randomly allocated to one of the two treatment groups to receive either the “mirror effect” treatment and the current pharmaceutical treatment recommended in Quebec, or the current pharmaceutical therapy recommended in Quebec at the moment plus counselling and a personalized exercise program 1 year after the onset of their Bell’s palsy, if needed. The severity of facial palsy is assessed at the initial assessment (10 to 14 days after onset) as well as 1, 2, 3, 4, 5, 6 and 12 months after onset

What are the possible benefits and risks of participating?
According to current knowledge, participation in this study does not involve any medical risk. Participants may get a personal benefit from their participation, but the researchers cannot guarantee it. By participating, they will be able to benefit from support and a meeting with a speech therapist experienced in the field, who will answer their questions.

Where is the study run from?
Hôpital du Sacré-Coeur de Montréal and Hôpital Maisonneuve-Rosemont (Canada)

When is the study starting and how long is it expected to run for?
September 2015 to October 2021

Who is funding the study?
1. Réseau Provincial en Adaptation – Réadaptation and the Ordre des Orthophonistes et Audiologistes du Québec (Canada)
2. Fonds de recherche du Québec- Santé (Canada)

Who is the main contact?
Karine Marcotte
karine.marcotte@umontreal.ca

Trial website

Contact information

Type

Scientific

Primary contact

Dr Karine Marcotte

ORCID ID

https://orcid.org/0000-0002-3275-1154

Contact details

5400 Gouin Ouest
Montréal
H4J 1C5
Canada
+1 (0)514 338 2222 extension 7710
karine.marcotte@umontreal.ca

Type

Public

Additional contact

Mrs Sarah Martineau

ORCID ID

Contact details

5400 Gouin Ouest
Montreal
H4J 1C5
Canada
+1 (0)514 338 2222 extension 7710
sarah.martineau.2@umontreal.ca

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

1

Study information

Scientific title

Efficacy of the Mirror Effect rehabilitation in acute Bell’s Palsy: a pilot study

Acronym

MEPP

Study hypothesis

The goal of this research study is to assess the feasibility of a future larger study on the Mirror Effect therapy for patients with Bell’s Palsy.

Ethics approval

Approved 25/11/2016, research ethics board of CIUSSS du Nord-de-l'Île-de-Montréal (5400 Gouin Ouest, Montréal, H4J 1C5, Canada; +1 (0)514 338 2222 ext. 3581; julie.hammamji.cnmtl@ssss.gouv.qc.ca), ref: MP-32-2017-1365

Study design

Multicenter longitudinal randomized feasibility study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Acute Bell's palsy

Intervention

In the present study, the researchers are recruiting a small number of patients to be able to obtain an estimate of the effectiveness of the new therapy called “Mirror Effect”. The Mirror Effect therapy will be combined with general recommendations given by the speech therapist and pharmaceutical treatment currently provided in Quebec. The researchers will compare this treatment to the usual course of treatment in Quebec, which is general recommendations given by the speech therapist and traditional pharmaceutical treatment. A positive outcome of this process will lead to a larger study to assess the efficacy of the Mirror Effect Therapy.

40 participants suffering from acute and severe Bell's palsy will be recruited and randomly attributed to one of the two treatment conditions. Assignation to the control group or MEPP group is performed by an external researcher who was not in direct contact with the patients, through computerized balanced block randomization. Thus, the 20 participants attributed to the experimental condition will receive the “mirror effect” treatment and the current pharmaceutical therapy recommended in Quebec, while the 20 other participants will be assigned to the control condition, which is the current pharmaceutical therapy recommended in Quebec at the moment plus counselling.

Treatment group: All participants receive the MEPP, a facial rehabilitation consisting of facial counselling and retraining during four in-clinic sessions during the first 2 weeks following the initial assessment. Each patient first receives information about facial function and anatomy. They then practise motor imagery (see Eaves et al., 2016) and receive passive soft tissue manipulation (Diels & Beurskens, 2014). Subsequently, specific facial exercises are explained and executed with the help of a free webpage (https://www.webcamtoy.com or MEPP web site https://mepp.marcottelab.ca/auth/signin) that provides modified visual biofeedback and a symmetrical image of the patient’s face generated by duplicating the healthy side. Instructions for facial exercises are provided to promote facial motor learning using small specific movements, emotional cueing, exercise randomization, and proper pacing. Exercises are continued at home twice daily until recovery was achieved.

Control group: The control group receive basic counselling such as instructions for avoiding excessive facial movements; however, participants did not attend therapy sessions. The control group will also receive a personalized exercise program 1 year after the onset of their Bell’s Palsy if needed.

For both groups: The first assessment is performed 10-14 days after BP onset and prior to any intervention or therapy. Reassessments are performed 1, 2, 3, 4, 5, 6 and 12 months after onset.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Severity of facial palsy assessed using the Facial Nerve Grading System 2.0 (FNGS 2.0; also known as the House-Brackmann 2.0 score and the Sunnybrook Facial Grading System at the initial assessment (10 to 14 days after onset) as well as 1, 2, 3, 4, 5, 6 and 12 months after onset

Secondary outcome measures

Speech intelligibility measured using a visual analog scale at the initial assessment (10 to 14 days after onset) as well as 1, 2, 3, 4, 5, 6 and 12 months after onset

Overall trial start date

03/09/2015

Overall trial end date

07/10/2121

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 years and older
2. First episode of Bell's Palsy
3. Having persistent severe Bell's palsy 10 days post-onset
4. Received the recommended drug regimen for severe and total BP (1000 mg valacyclovir three times daily for 7 days and 50 mg prednisone once daily for 10 days) began within 72 hours of onset
5. Normal cognitive status based on the Montreal Cognitive Assessment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Total final enrolment

40

Participant exclusion criteria

1. History of trauma to the 7th cranial nerve
2. Having suffered from Bell's palsy previously or any other facial palsy of another origin (e.g. secondary to surgery or a syndrome
3. History of neurological disorders (e.g. stroke, neurodegenerative diseases)
4. Psychiatric illness on active treatment (e.g. schizophrenia, severe depression)
5. History of neoplastic diseases

Recruitment start date

27/02/2017

Recruitment end date

07/10/2020

Locations

Countries of recruitment

Canada

Trial participating centre

CIUSSS Nord-de-l'île-de-Montréal (Hôpital du Sacré-Coeur de Montréal)
5400 Gouin Ouest
Montréal
H4J 1C5
Canada

Trial participating centre

CIUSSS Est-de-l'île-de-Montréal (Hôpital Maisonneuve-Rosemont)
5415, boulevard de l'Assomption
Montréal
H1T 2M4
Canada

Sponsor information

Organisation

Centres Intégré Universitaires de Santé et de Services Sociaux

Sponsor details

Hôpital du Sacré-Cœur-de-Montréal
Direction de la recherche
de l’enseignement et de l’innovation
5400
boul. Gouin Ouest
Montreal
H4J 1C5
Canada
+1 (0)514 338 2222
appui.recherche.cnmtl@ssss.gouv.qc.ca

Sponsor type

University/education

Website

https://rechercheciusssnim.ca

Funders

Funder type

Research organisation

Funder name

Réseau provincial en adaptation-réadaptation and Ordre des orthophonistes et audiologistes du Québec

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Fonds de recherche Québec-Santé

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The longitudinal data of all participants will be submitted for publication in a peer-reviewed journal by the end of 2021 or the beginning of 2022.

2020 preliminary results in https://www.cjslpa.ca/detail.php?ID=1260&lang=en

IPD sharing statement
According to the informed consent, data will only be accessed by researchers and team members (which is standard procedure in Quebec). Research data will be stored at the Hôpital du Sacré-Coeur de Montréal in a safe location by researchers responsible for the research project for a period of 5 years, after which the research files will be destroyed and can be consulted only by the participants in the research project.

Intention to publish date

01/01/2022

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/11/2020: Trial's existence confirmed by the research ethics board of CIUSSS du Nord-de-l'Île-de-Montréal.