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Trial registered on ANZCTR


Registration number
ACTRN12617001269325
Ethics application status
Approved
Date submitted
10/08/2017
Date registered
1/09/2017
Date last updated
16/07/2019
Date data sharing statement initially provided
16/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Swallowing skill training in neurodegenerative disease.
Scientific title
Skill based dysphagia therapy as an intervention for individuals with Amyotrophic Lateral
Sclerosis or Huntington’s Disease.
Secondary ID [1] 292598 0
Nil known.
Universal Trial Number (UTN)
U1111-1200-3369
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Amyotrophic Lateral Sclerosis 304274 0
Motor Neurone Disease 304275 0
Huntington's Disease 304276 0
Dysphagia 304277 0
Condition category
Condition code
Neurological 303623 303623 0 0
Neurodegenerative diseases
Physical Medicine / Rehabilitation 303624 303624 0 0
Speech therapy
Oral and Gastrointestinal 303884 303884 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Rehabilitative intervention will be delivered face-to-face by University of Canterbury research personnel who also hold professional qualifications in Speech and Language Therapy. Intervention will comprise of 5 x 1 hour sessions per week for two weeks at the University of Canterbury Rose Centre for Stroke Recovery and Research.

Treatment will use surface electromyography (sEMG) hardware and the custom designed Biofeedback in Strength and Skill Training (BiSSkiT) software (Huckabee, Sella, Jones & Han). The software is designed to incorporate skill training approaches with the aim to improve patients’ conscious control and precision over swallowing. Participants will be seated facing the computer screen. sEMG electrodes on a small self-adhesive patch, will be adhered under the participant’s chin over the submental muscles (geniohyoid, mylohyoid and anterior bellies of the digastric). The patch and electrodes will also be secured with medical tape to minimise interference from involuntary limb movements. The sEMG electrodes will be attached to a Verity Medical Myotrac Simplex Plus device, which then sends the sEMG signal either via Bluetooth to the computer and displays the sEMG data through the BiSSkiT software. Activity of the submental muscles will be displayed as a time by amplitude waveform. The parameters of the participant’s swallow are set in the first session using a calibration sequence where the participant completes five effortful swallows over 150 seconds. BiSSkit software utilises the amplitude of the calibration trials to provide a ‘target’ box randomly placed on the screen, between 30 and 70% of the participants’ average maximal amplitude during effortful swallowing. Each 30 second trial requires the participant to dry swallow such that the peak of the waveform falls within the centre of the target box. There are 10 trials per block, and eight blocks per session, separated by a 90 second rest periods. The accuracy and precision of the skill is targeted as the participant is required to consciously modify the timing and amplitude of their swallowing during each trial, based on feedback from a previous trial. They receive immediate auditory and visual feedback to inform them of the success of their performance. The task is made more difficult as the participant’s accuracy improves as the target box decreases by 10% following three consecutive successful ‘hits’. The box also increases in size by 10% following three consecutive ‘misses’ to reduce task difficulty.

BiSSkiT software provides data on each trial, and a summary of 'hit' accuracy per one hour session. The researchers will monitor task adherence during the session, and examine summary data to ensure participants are completing the protocol as designed. For example, ensuring each peaked waveform corresponds to a full swallow.
Intervention code [1] 298809 0
Rehabilitation
Intervention code [2] 299003 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302996 0
Oropharyngeal functional swallowing of solids (number of bites, masticatory cycles, swallows and total time): measured by the Test of Masticating and Swallowing Solids.


Timepoint [1] 302996 0
Measures collected at 4 time points:
Baseline (2 weeks no-treatment phase), pre-treatment, post-treatment (2 week treatment retention phase), final measure (2 weeks post completion of treatment).
Primary outcome [2] 302997 0
Patient reported quality of life (dysphagia symptom specific): measured by Swallowing Quality of Life Questionnaire.
Timepoint [2] 302997 0
Measures collected at 4 timepoints:
Baseline (2 weeks no-treatment phase), pre-treatment, post-treatment (2 week treatment retention phase), final measure (2 weeks post completion of treatment).
Primary outcome [3] 303253 0
Oropharyngeal functional swallowing of fluids (swallow time, volume and capacity): measured by the Timed Water Swallow Test.
Timepoint [3] 303253 0
Measures collected at 4 timepoints:
Baseline (2 weeks no-treatment phase), pre-treatment, post-treatment (2 week treatment retention phase), final measure (2 weeks post completion of treatment).
Secondary outcome [1] 337650 0
Pharyngeal pressures including transit time measured by : Combined videofluoroscopic swallowing study and low resolution manometry.
Timepoint [1] 337650 0
Measures collected at 4 timepoints:
Baseline (2 weeks no-treatment phase), pre-treatment, post-treatment (2 week treatment retention phase), final measure (2 weeks post completion of treatment).
Secondary outcome [2] 337651 0
Anterior hyoid movement measured by ultrasound.
Timepoint [2] 337651 0
Measures collected at 4 timepoints:
Baseline (2 weeks no-treatment phase), pre-treatment, post-treatment (2 week treatment retention phase), final measure (2 weeks post completion of treatment).
Secondary outcome [3] 338421 0
Cross sectional area of the submental muscles measured by ultrasound.
Timepoint [3] 338421 0
Measures collected at 4 timepoints:
Baseline (2 weeks no-treatment phase), pre-treatment, post-treatment (2 week treatment retention phase), final measure (2 weeks post completion of treatment).
Secondary outcome [4] 338422 0
Aspiration-Penetration scale: rated during combined videofluoroscopic swallowing study and low resolution manometry.
Timepoint [4] 338422 0
Measures collected at 4 timepoints:
Baseline (2 weeks no-treatment phase), pre-treatment, post-treatment (2 week treatment retention phase), final measure (2 weeks post completion of treatment).
Secondary outcome [5] 338423 0
Hyolaryngeal excursion: measured by combined videofluoroscopic swallowing study and low resolution manometry.
Timepoint [5] 338423 0
Measures collected at 4 timepoints:
Baseline (2 weeks no-treatment phase), pre-treatment, post-treatment (2 week treatment retention phase), final measure (2 weeks post completion of treatment).
Secondary outcome [6] 350408 0
MRI with diffusion tensor imaging will be completed on up to 3 participants in this study. DT images will be pre-processed in SPM and probabilistic tractography will be performed. Seed points for tractography will be placed in the bilateral supplementary motor area, primary motor cortices (pharynx), anterior cerebellum, and lateral medulla
Timepoint [6] 350408 0
Measures collected at 2 time points: Immediately pre-treatment and post-treatment.

Eligibility
Key inclusion criteria
Diagnosis of Probable or definite Amyotrophic Lateral Sclerosis as measured by the El Escorial Criteria with a minimum ALSFRS-R bulbar subscale score of 9
OR
Diagnosis of HD through clinical symptoms confirmed by a neurologist and the presence of greater than or equal to 36 CAG repeats on genetic testing

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will not be eligible if they:
Score less than 26 on the Montreal Cognitive Assessment
Have a co-occurring condition that may effect swallowing
Score less than 3 on the Eating Assessment Tool 10
Are unable to eat solid textures or drink thin liquids

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No allocation, all participants receive intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
ABA type trial with all participants undergoing a period of no intervention followed by intervention then final period of no intervention to assess retention.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This is proof of concept research, therefore sample size calculations could not be conducted. Information collected in this research may be used for future sample size calculations.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9133 0
New Zealand
State/province [1] 9133 0
Canterbury
Country [2] 9134 0
United States of America
State/province [2] 9134 0
New York

Funding & Sponsors
Funding source category [1] 297187 0
University
Name [1] 297187 0
University of Canterbury Rose Centre for Stroke Recovery and Research
Address [1] 297187 0
Level 1, Leinster Chambers,
St. Georges Medical Centre,
249 Papanui Road,
Christchurch 8140
Country [1] 297187 0
New Zealand
Primary sponsor type
University
Name
University of Canterbury Rose Centre for Stroke Recovery and Research
Address
Level 1, Leinster Chambers,
St. Georges Medical Centre,
249 Papanui Road,
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 296209 0
None
Name [1] 296209 0
Address [1] 296209 0
Country [1] 296209 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298343 0
Health and DIsability Ethics Committee
Ethics committee address [1] 298343 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 298343 0
New Zealand
Date submitted for ethics approval [1] 298343 0
08/09/2017
Approval date [1] 298343 0
20/12/2017
Ethics approval number [1] 298343 0
17/NTB/214/AM01

Summary
Brief summary
Aim:
To evaluate the effectiveness of skill training on functional swallowing and quality of life in patients with Amyotrophic Lateral Sclerosis (ALS) or Huntington’s Disease (HD).
Procedure:
Participants will attend four assessment and ten treatment sessions over a six week period. Treatment will consist of ten sessions over two weeks. This is both preceded and followed by a no treatment block to evaluate the
treatment and maintenance effects.

Rehabilitation sessions will consist of skill training via the Biofeedback in Strength and Skill Training (BiSSkiT) protocol. This utilises surface electromyography (sEMG) as a form of biofeedback while swallowing. SEMG will measure the activity of swallowing muscles with electrodes which are placed under the chin on the skin's surface.
SEMG waveforms are displayed on a computer monitor allowing participants to visualise and cortically control their muscle activity while swallowing. A challenge task is included in the software, encouraging cortical control of swallowing. A target box will randomly appear on the screen and participants will attempt swallow such that the peak of the swallow waveform lands within the target box.
Outcome measures include both clinical and instrumental measures of swallowing as well as self reported quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76778 0
Ms Emma Burnip
Address 76778 0
University of Canterbury Rose Centre for Stroke Recovery and Research
Private Bag 4737
St George's Medical Centre
Christchurch 8140
Country 76778 0
New Zealand
Phone 76778 0
+6433692385
Fax 76778 0
Email 76778 0
emma.burnip@pg.canterbury.ac.nz
Contact person for public queries
Name 76779 0
Ms Emma Burnip
Address 76779 0
University of Canterbury Rose Centre for Stroke Recovery and Research
Private Bag 4737
St George's Medical Centre
Christchurch 8140
Country 76779 0
New Zealand
Phone 76779 0
+6433692385
Fax 76779 0
Email 76779 0
emma.burnip@pg.canterbury.ac.nz
Contact person for scientific queries
Name 76780 0
Ms Emma Burnip
Address 76780 0
Univeristy of Canterbury Rose Centre for Stroke Recovery and Research
Private Bag 4737
St George's Medical Centre
Christchurch 8140
Country 76780 0
New Zealand
Phone 76780 0
+64 3 3692385
Fax 76780 0
Email 76780 0
emma.burnip@pg.canterbury.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not have ethical approval to release the data in that way.
What supporting documents are/will be available?
No other documents available
Summary results
No Results