Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000628448p
Ethics application status
Submitted, not yet approved
Date submitted
24/05/2025
Date registered
16/06/2025
Date last updated
16/06/2025
Date data sharing statement initially provided
16/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Brain Change Following Swallowing Skill Training in Patients with Parkinson's Disease
Scientific title
Evaluation of Neurological Change Following Swallowing Skill Training in Patients with Dysphagia Secondary to Parkinson’s Disease
Secondary ID [1] 314316 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysphagia 337596 0
Swallowing impairment 337597 0
Parkinson's disease 337598 0
Condition category
Condition code
Neurological 333942 333942 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 333943 333943 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This exploratory pilot study will investigate neurological change following a period of swallowing skill training for patients with dysphagia (swallowing disorder) secondary to Parkinson’s disease. Eight participants will engage in a four-week period of swallowing skill training, completed predominantly in their own homes, using the Biofeedback in Strength and Skill Application (BiSSkApp [Registered Trademark]) to deliver the training.
Brain imaging assessment will include magnetic resonance imaging (MRI) and electroencephalography (EEG). MRI will be conducted at two timepoints: pre- and post-training, approximately four weeks apart. These scans will be conducted by qualified MRI technologists employed by Pacific Radiology and will not require administration of any dyes or contrast. Each scan will take up to 1.5 hours, including setup time. Electroencephalography will be conducted by the primary researcher at three timepoints concurrently with training: during the first, third, and final skill training sessions. It is anticipated that these sessions will take up to two hours each, including setup time.
Swallowing skill training is a rehabilitation approach that aims to improve swallowing at the central level, by targeting motor control and coordination. Surface electromyography (sEMG) overlaying the participant’s floor of mouth muscles (i.e., under their chin) detects muscle activation during swallowing. This activity is presented as a live time-by-amplitude waveform that is displayed on a tablet screen, effectively allowing participants to see a visual representation of their swallowing behaviour. Participants use this waveform as a biofeedback tool to volitionally modulate temporal and amplitude elements of their swallowing (i.e., muscle timing and force) to “hit” a target box positioned in unexpected locations on the tablet screen with each trial.
Introduction to and support with the intervention will be provided by a qualified speech-language therapist. The introductory session for the training will take place in a research centre setting and involve the aforementioned concurrent EEG recording, which may take up to two hours, including setup time. Participants will complete up to 100 swallowing skill training trials per day (i.e., approximately 1 hour per day, five days per week, for four weeks). Most training sessions will be completed in participants' own homes and time, except for the first, third, and final sessions, which will be conducted in a research centre setting. It is acknowledged that an intensive therapy block such as this may be challenging for individuals who may be experiencing continuing effects of neurological disease such as fatigue. As such, this planned intensity may be modified according to individual needs. For example, a participant may break the swallowing trials into smaller sessions (e.g., five sessions of 20 swallows). Total number of trials per day may also be reduced if necessary, but, again, this will be determined on an individual basis through a clinical, patient-centred lens, with participants maintaining the maximum number of trials they can tolerate.
The primary researcher will check in with participants once per week (via their preferred modality, e.g., telephone) to evaluate how they are finding the training and to make adaptations as needed. The researcher will also monitor the participant’s adherence to the training programme via a remote clinician portal and, if training sessions are missed, will contact them to discuss reasons for this and to troubleshoot. Additionally, patients will be able to contact the research team to discuss any issues or questions they may have relating to the research or training.
Intervention code [1] 331146 0
Rehabilitation
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341597 0
Change in mean kurtosis (MK) values for supplementary motor area (SMA)-medullary white matter projections.
Timepoint [1] 341597 0
Pre- and post- training (i.e., approximately 4 weeks apart).
Primary outcome [2] 341728 0
Change in MK values for primary motor area (M1)-medullary white matter projections.
Timepoint [2] 341728 0
Pre- and post-training (i.e., approximately 4 weeks apart).
Primary outcome [3] 341729 0
Change in MK values for SMA grey matter.
Timepoint [3] 341729 0
Pre- and post-training (i.e., approximately 4 weeks apart).
Secondary outcome [1] 448030 0
Change in MK values for M1 grey matter (note: this is a primary outcome).
Timepoint [1] 448030 0
Pre- and post-training (i.e., approximately 4 weeks apart).
Secondary outcome [2] 448031 0
Change in biomechanical swallowing presentation.
Timepoint [2] 448031 0
Pre- and post-training (i.e., approximately 4 weeks apart).
Secondary outcome [3] 448032 0
Change to timing measures of swallowing.
Timepoint [3] 448032 0
Pre- and post-training (i.e., approximately 4 weeks apart).
Secondary outcome [4] 448033 0
Change in swallowing skill performance.
Timepoint [4] 448033 0
First, third, and final swallowing skill training sessions.
Secondary outcome [5] 448034 0
Change in contingent negative variation (CNV) amplitude.
Timepoint [5] 448034 0
First, third, and final swallowing skill training sessions.
Secondary outcome [6] 448035 0
Change in solid ingestion efficiency.
Timepoint [6] 448035 0
Pre- and post-training (i.e., approximately 4 weeks apart).
Secondary outcome [7] 448545 0
Change in fluid ingestion efficiency.
Timepoint [7] 448545 0
Pre- and post-training (i.e., approximately 4 weeks apart).
Secondary outcome [8] 448546 0
Change in self-reported swallowing experiences.
Timepoint [8] 448546 0
Pre- and post-training (i.e., approximately 4 weeks apart).

Eligibility
Key inclusion criteria
To be eligible for participation, participants must meet the following inclusion criteria:
* Be an adult (aged 18+)
* Have a diagnosis of Parkinson’s disease
* Have dysphagia (i.e., abnormal findings on screen, then later confirmed on VFSS)
* Consent to shaving the submental surface area (i.e., under chin) during study treatment/assessment to ensure adhesion of the electrode patch
* Have internet access at their home (to use rehabilitation software)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants meeting any of the following exclusion criteria will not be included:
* Presence of cognitive impairment (mild or greater, as measured by a score of 25 or less on the Montreal Cognitive Assessment [MoCA])
* Presence of neurological condition other than Parkinson’s disease
* Presence of any other medical condition affecting swallowing (e.g., head and neck cancer)
* Deemed legally blind
* Unable to undergo magnetic resonance imaging (MRI) (e.g., have a Pacemaker or neural stimulator) or VFSS (e.g., be pregnant at the times of assessment)
* Undergoing (coincident with participation or within the month prior to recruitment) alternative active rehabilitation for dysphagia

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to analyse data. Changes to primary and secondary outcome measures will be evaluated descriptively between timepoints and one another.
DKI will be used to determine changes to neurological structure. Changes in MK values, after compared to before the training period, will be evaluated in key white and grey matter areas associated with swallowing (SMA-medulla white matter projections, M1-medulla white matter projections, and SMA and M1 grey matter). Changes in MK for each of these areas will be descriptively compared with several other measures.
Changes to swallowing (such as biomechanical measures identified using VFSS, and ToMaSS, TWST, and EAT-10 data) will be compared to changes in MK values. Swallowing skill precision scores over time will reflect changes to performance in the swallowing skill task and will also be compared to these MK values. Finally, EEG measurement of CNV may reveal changes to neurological function in terms of measures related to motor planning, and thus will also be compared to both swallowing skill precision scores and MK values to descriptively evaluate the relationship between these.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
31/01/2026
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment outside Australia
Country [1] 27081 0
New Zealand
State/province [1] 27081 0
Canterbury

Funding & Sponsors
Funding source category [1] 318838 0
University
Name [1] 318838 0
University of Canterbury
Country [1] 318838 0
New Zealand
Funding source category [2] 319068 0
Charities/Societies/Foundations
Name [2] 319068 0
RHCNZ Research and Education Trust
Country [2] 319068 0
New Zealand
Funding source category [3] 319069 0
Charities/Societies/Foundations
Name [3] 319069 0
Neurological Foundation
Country [3] 319069 0
New Zealand
Funding source category [4] 319070 0
Commercial sector/Industry
Name [4] 319070 0
Swallowing Technologies Ltd.
Country [4] 319070 0
New Zealand
Primary sponsor type
University
Name
University of Canterbury
Address
Country
New Zealand
Secondary sponsor category [1] 321530 0
None
Name [1] 321530 0
Address [1] 321530 0
Country [1] 321530 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317455 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 317455 0
Ethics committee country [1] 317455 0
New Zealand
Date submitted for ethics approval [1] 317455 0
22/05/2025
Approval date [1] 317455 0
Ethics approval number [1] 317455 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141086 0
Ms Madeline Mills
Address 141086 0
UC Rose Centre for Stroke Recovery and Research, Level 1 Leinster Chambers, 249 Papanui Road, Strowan, Christchurch 8014
Country 141086 0
New Zealand
Phone 141086 0
+64 3 369 2385
Fax 141086 0
Email 141086 0
[email protected]
Contact person for public queries
Name 141087 0
Madeline Mills
Address 141087 0
UC Rose Centre for Stroke Recovery and Research, Level 1 Leinster Chambers, 249 Papanui Road, Strowan, Christchurch 8014
Country 141087 0
New Zealand
Phone 141087 0
+64 3 369 2385
Fax 141087 0
Email 141087 0
[email protected]
Contact person for scientific queries
Name 141088 0
Madeline Mills
Address 141088 0
UC Rose Centre for Stroke Recovery and Research, Level 1 Leinster Chambers, 249 Papanui Road, Strowan, Christchurch 8014
Country 141088 0
New Zealand
Phone 141088 0
+64 3 369 2385
Fax 141088 0
Email 141088 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 10 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Via email to the UC Rose Centre for Stroke Recovery and Research ([email protected]).

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol  [email protected] Available via email upon project completion.
Informed consent form  [email protected] Available via email upon project completion.


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.