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Trial registered on ANZCTR


Registration number
ACTRN12612001176853
Ethics application status
Approved
Date submitted
2/11/2012
Date registered
6/11/2012
Date last updated
7/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Mental Imagery for Facial Action Control Enhancement after nerve damage
Scientific title
A randomised controlled trial to investigate cortical changes associated with mental imagery of facial movements following facial nerve paralysis as measured with functional Magnetic Resonance Imaging
Secondary ID [1] 281492 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
MiFACE Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower motor neurone facial nerve paralysis 287763 0
Condition category
Condition code
Neurological 288103 288103 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 288104 288104 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mental Imagery Training Program
Participants will be given instruction and training by the research manager to enable them to undertake a mental imagery training program. This will involve imagining themselves smiling during particular situations which may be unique to each participant. A 3 minute unsupervised mental imagery training session will then be undertaken by the participants as a home-training program 3 times per day after facial nerve paralysis before movement recommences and continued for 3 months after facial movement returns. During this time, they will imagine themselves smiling and producing happy facial expressions.
Intervention code [1] 286005 0
Rehabilitation
Comparator / control treatment
Usual care. This involves waiting until facial movement returns with no exercises and no mental imagery training. Eye care, as specified by their treating doctor, will be emphasized by the research manager and gentle facial massage and warm moist heat may be applied at home by the participant once or twice daily. The participants will be contacted by the researchers once per month over the phone to assess progress, and will be advised as to what to look for when facial movement returns. When facial movement does return, both groups will be given usual care which involves a home program of specific facial exercises performed in front of a mirror 3 -5 x /day for 5 minutes/session which are designed to maximise recovery of facial movement. Only the intervention group will continue with mental imagery training as well as usual care until 3 months after facial movement has returned.
Control group
Active

Outcomes
Primary outcome [1] 288308 0
Neuronal activity as assessed by Blood-oxygenation level dependent functional magnetic resonance imaging (fMRI BOLD) score
Timepoint [1] 288308 0
1. Within three weeks after the onset of the facial nerve paralysis when randomisation occurs
2. Two months after randomisation
3. At the time of first facial movement return
4. At 3 months after facial movement return
Secondary outcome [1] 299811 0
Facial symmetry and facial movements assessed using the House Brackmann Facial Grading System
Timepoint [1] 299811 0
1. Within three weeks after the onset of the facial nerve paralysis when randomisation occurs
2. Two months after randomisation
3. At the time of first facial movement return
4. At 3 months after facial movement return
Secondary outcome [2] 299812 0
Facial movements assessed using the Sydney Facial Grading System
Timepoint [2] 299812 0
1. Within three weeks after the onset of the facial nerve paralysis when randomisation occurs
2. Two months after randomisation
3. At the time of first facial movement return
4. At 3 months after facial movement return
Secondary outcome [3] 299813 0
Facial movements assessed using the Sunnybrook Facial Grading System
Timepoint [3] 299813 0
1. Within three weeks after the onset of the facial nerve paralysis when randomisation occurs
2. Two months after randomisation
3. At the time of first facial movement return
4. At 3 months after facial movement return
Secondary outcome [4] 299814 0
Self assessed quality of life assessed using the SF-36 Quality of Life Questionnaire
Timepoint [4] 299814 0
1. Within three weeks after the onset of the facial nerve paralysis when randomisation occurs
2. Two months after randomisation
3. At the time of first facial movement return
4. At 3 months after facial movement return
Secondary outcome [5] 299815 0
Self assessed quality of life assessed using the Facial Disability Index
Timepoint [5] 299815 0
1. Within three weeks after the onset of the facial nerve paralysis when randomisation occurs
2. Two months after randomisation
3. At the time of first facial movement return
4. At 3 months after facial movement return
Secondary outcome [6] 299816 0
Vividness of mental Imagery assessed using the Roberts et al (2008) Vividness of Mental Imagery Questionnaire
Timepoint [6] 299816 0
1. Within three weeks after the onset of the facial nerve paralysis when randomisation occurs
2. Two months after randomisation
3. At the time of first facial movement return
4. At 3 months after facial movement return
Secondary outcome [7] 299817 0
Standardised Series of facial movements assessed using videotape and photographs
Timepoint [7] 299817 0
1. Within three weeks after the onset of the facial nerve paralysis when randomisation occurs
2. Two months after randomisation
3. At the time of first facial movement return
4. At 3 months after facial movement return
Secondary outcome [8] 299818 0
Viewers ratings of a randomised set of photographs of participants faces (taken at the 4 timepoints listed above for the photographs) using the Facial Rating Form to assess symmetry, movement control and overall smile quality
Timepoint [8] 299818 0
At the completion of data collection for all facial nerve participants
Secondary outcome [9] 299819 0
Reaction Time (RT) and Movement Time (MT) testing of smile and eye closure to assess speed of cortical processing
Timepoint [9] 299819 0
1. At the time of first facial movement return
2. At 3 months after facial movement return

Eligibility
Key inclusion criteria
Participants to be within 3 months after onset of a complete unilateral lower motor neurone facial nerve paralysis with a prognosis of 3 months or longer before the return of facial movement.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A unilateral lower motor neurone facial nerve paralysis with a prognosis of 3 months or longer before the return of facial movement.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (ie. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/11/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5938 0
2228
Recruitment postcode(s) [2] 5939 0
2165
Recruitment postcode(s) [3] 5940 0
2007
Recruitment postcode(s) [4] 5941 0
2122
Recruitment postcode(s) [5] 5942 0
2122
Recruitment postcode(s) [6] 5943 0
2250
Recruitment postcode(s) [7] 5944 0
2042
Recruitment postcode(s) [8] 5945 0
2010
Recruitment postcode(s) [9] 5946 0
2135
Recruitment postcode(s) [10] 5947 0
2144
Recruitment postcode(s) [11] 5948 0
2010
Recruitment postcode(s) [12] 5949 0
2031
Recruitment postcode(s) [13] 5950 0
2060
Recruitment postcode(s) [14] 5951 0
2065
Recruitment postcode(s) [15] 5952 0
2217
Recruitment postcode(s) [16] 5953 0
2076
Recruitment postcode(s) [17] 5954 0
2077
Recruitment postcode(s) [18] 5955 0
2065
Recruitment postcode(s) [19] 5956 0
2600
Recruitment postcode(s) [20] 5957 0
2305
Recruitment postcode(s) [21] 5958 0
2050
Recruitment postcode(s) [22] 5959 0
2134

Funding & Sponsors
Funding source category [1] 286268 0
Charities/Societies/Foundations
Name [1] 286268 0
The Garnett Passe and Rodney Williams Memorial Foundation
Country [1] 286268 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Faculty of Health Sciences
Cumberland Campus
PO Box 70
Lidcombe
NSW 1825
Country
Australia
Secondary sponsor category [1] 285068 0
None
Name [1] 285068 0
Address [1] 285068 0
Country [1] 285068 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288343 0
Human Research Ethics Committee, The University of Sydney
Ethics committee address [1] 288343 0
Level 6, Jane Foss Russell Building - G02 The University of Sydney NSW 2006
Ethics committee country [1] 288343 0
Australia
Date submitted for ethics approval [1] 288343 0
Approval date [1] 288343 0
28/03/2012
Ethics approval number [1] 288343 0
14563

Summary
Brief summary
The primary purpose of this study is to investigate whether early intervention can improve outcomes following acute lower motor neurone facial nerve paralysis. The hypothesis is that by commencing mental imagery training during the time of complete facial nerve paralysis facial movements and quality of life will be improved following movement return.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 34915 0
Address 34915 0
Country 34915 0
Phone 34915 0
Fax 34915 0
Email 34915 0
Contact person for public queries
Name 18162 0
Dr Susan Coulson
Address 18162 0
The University of Sydney
Faculty of Health Sciences
Cumberland Campus
PO Box 70
Lidcombe
NSW 1825
Country 18162 0
Australia
Phone 18162 0
+61 2 93519416
Fax 18162 0
+61 2 9359278
Email 18162 0
[email protected]
Contact person for scientific queries
Name 9090 0
Dr Susan Coulson
Address 9090 0
The University of Sydney
Faculty of Health Sciences
Cumberland Campus
PO Box 70
Lidcombe
NSW 1825
Country 9090 0
Australia
Phone 9090 0
+61 2 93519416
Fax 9090 0
+61 2 9359278
Email 9090 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.