Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000436572
Ethics application status
Approved
Date submitted
21/04/2015
Date registered
7/05/2015
Date last updated
8/01/2019
Date data sharing statement initially provided
8/01/2019
Date results provided
8/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The influence of cerebellar transcranial direct current stimulation (tDCS) on motor learning in swallowing rehabilitation.
Scientific title
The effect of skill training and simultaneous cerebellar tDCS on swallowing in patients with swallowing disorders.
Secondary ID [1] 286572 0
Nil
Universal Trial Number (UTN)
U1111-1168-9523
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysphagia 294827 0
Condition category
Condition code
Physical Medicine / Rehabilitation 295100 295100 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is an interventional case series investigation that will evaluate the influence of cerebellar tDCS on motor skill acquisition as a component of rehabilitation in patients with swallowing disorders (dysphagia).
Two previously published skill training treatment procedures will be used to restore swallowing function: Biofeedback in Strength and Skill Training (BiSSkiT) (Athukorala et al., 2014) or mis-sequencing therapy using manometry (Huckabee et al., 2014).
The BiSSkiT protocol involves one treatment session daily for up to an hour maximum. The patient will be verbally guided to control temporal and amplitude characteristics of the floor-of-mouth muscles such that the observed sEMG waveform gets as close to a target on the screen during swallowing as possible. The manometry treatment will be twice daily for up to an hour maximum for each session. It involves measurement of pharyngeal pressure using low-resolution manometry. The skill based rehabilitation approach will be assigned based on their evaluation of swallowing function. The treatment will be administered by a qualified and trained Speech-language therapist.

Cerebellar tDCS will be applied during these usual treatment procedures at the EATS (Evaluation and Treatment of Swallowing) Clinic, situated at the University of Canterbury Rose Centre for Stroke Recovery and Research. Cerebellar tDCS will be applied for 20 min during the skill training protocol in daily, or twice daily, treatment sessions for two weeks (weekdays only). Stimulation will be applied at 2 mA, delivered via three rectangular saline-soaked sponge electrodes (5×5 cm, surface area 25 cm^2). Stimulation via these parameters induces a current at a density of 0.08 mA/cm^2, which is considered to be safe for human participants (Iyer et al., 2005).
Intervention code [1] 291685 0
Rehabilitation
Intervention code [2] 291686 0
Treatment: Devices
Comparator / control treatment
Pre-existing data out of the patients previous swallowing treatment and evaluation measures collected within the last five years will serve as control treatment.
Control group
Historical

Outcomes
Primary outcome [1] 294861 0
Timing and magnitude of the sEMG waveform in correlation to the target will be outcome measures for the BiSSkiT treatment.
Timepoint [1] 294861 0
Pre and post treatment measures will be gathered in the first and last session. Furthermore, follow-up measures after week one and two will be collected when available.
Primary outcome [2] 294953 0
Latency between the peaks of the pharyngeal manometry waveform will be analysed as outcome for the manometry treatment.
Timepoint [2] 294953 0
Pre and post treatment measures will be gathered in the first and last session. Furthermore, follow-up measures after week one and two will be collected when available.
Secondary outcome [1] 314237 0
Videofluoroscopic evaluation of swallowing (VFSS) will be performed to asses the overall swallowing function.
Timepoint [1] 314237 0
Pre and post treatment VFSS measures will be gathered before and after the first and last session. Furthermore, follow-up VFSS measures after week one and two will be collected when available.
Secondary outcome [2] 314468 0
Timed water swallow test (TWST) (Hughes & Wiles, 1996)
Timepoint [2] 314468 0
Pre and post treatment TWST measures will be gathered before and after the first and last session. Furthermore, follow-up TWST measures after week one and two will be collected when available.
Secondary outcome [3] 314469 0
Test of Mastication and Swallowing of Solids (TOMASS)
Timepoint [3] 314469 0
Pre and post treatment TOMASS measures will be gathered before and after the first and last session. Furthermore, follow-up TOMASS measures after week one and two will be collected when available.
Secondary outcome [4] 314470 0
Swallowing related quality of life questionnaire (SWAL-QOL)
Timepoint [4] 314470 0
Pre and post treatment the patient will be asked to complete the SWAL-QOL before and after the first and last session. Furthermore, the patient will be asked to complete the SWAL-QOL as a follow-up after week one and two, when available.

Eligibility
Key inclusion criteria
This study will include patients with oropharyngeal dysphagia, aged 18 years or older, who have not resumed functional oral intake following previous swallowing treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients that have undergone recent brain surgery (within the last 6 month), metallic implants in the skull, and a history of drug use will be excluded. Further exclusion criteria for participation include difficulties following instructions because of cognitive impairment, or limitations in visual function (acuity in both eyes < 6/12).

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A mixed effects model will be used to evaluate learning and transfer effects of the learned skill.

The results of this study will provide power calculation data for a more robust clinical trial of the same treatment.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/05/2015
Actual
25/05/2015
Date of last participant enrolment
Anticipated
31/01/2017
Actual
14/11/2016
Date of last data collection
Anticipated
Actual
25/11/2016
Sample size
Target
6
Accrual to date
Final
6
Recruitment outside Australia
Country [1] 6837 0
New Zealand
State/province [1] 6837 0
Canterbury

Funding & Sponsors
Funding source category [1] 291135 0
University
Name [1] 291135 0
The University of Canterbury Rose Centre for Stroke Recovery and Research
Country [1] 291135 0
New Zealand
Funding source category [2] 291196 0
University
Name [2] 291196 0
New Zealand Brain Research Doctoral Scholarship
Country [2] 291196 0
New Zealand
Primary sponsor type
University
Name
The University of Canterbury Rose Centre for Stroke Recovery and Research
Address
St George’s Medical Centre
Leinster Chambers, Level One
Private Bag 4737
249 Papanui Road
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 289875 0
None
Name [1] 289875 0
Address [1] 289875 0
Country [1] 289875 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292712 0
Health and Disability Ethics Committes (HDEC)
Ethics committee address [1] 292712 0
Ethics committee country [1] 292712 0
New Zealand
Date submitted for ethics approval [1] 292712 0
23/04/2015
Approval date [1] 292712 0
06/05/2015
Ethics approval number [1] 292712 0

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

Contacts
Principal investigator
Name 56686 0
Ms Kerstin Erfmann
Address 56686 0
The University of Canterbury Rose Centre for Stroke Recovery and Research at St George’s Medical Centre
Leinster Chambers, Level One
Private Bag 4737
249 Papanui Road
Christchurch 8140
Country 56686 0
New Zealand
Phone 56686 0
+6433642307
Fax 56686 0
+64 3 375 6267
Email 56686 0
[email protected]
Contact person for public queries
Name 56687 0
Kerstin Erfmann
Address 56687 0
The University of Canterbury Rose Centre for Stroke Recovery and Research at St George’s Medical Centre
Leinster Chambers, Level One
Private Bag 4737
249 Papanui Road
Christchurch 8140
Country 56687 0
New Zealand
Phone 56687 0
+6433642307
Fax 56687 0
+64 3 375 6267
Email 56687 0
[email protected]
Contact person for scientific queries
Name 56688 0
Kerstin Erfmann
Address 56688 0
The University of Canterbury Rose Centre for Stroke Recovery and Research at St George’s Medical Centre
Leinster Chambers, Level One
Private Bag 4737
249 Papanui Road
Christchurch 8140
Country 56688 0
New Zealand
Phone 56688 0
+6433642307
Fax 56688 0
+64 3 375 6267
Email 56688 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data has not been published yet.


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.