Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000521729
Ethics application status
Approved
Date submitted
20/10/2021
Date registered
1/04/2022
Date last updated
1/04/2022
Date data sharing statement initially provided
1/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Does exercise therapy with non-invasive low level cerebellar stimulation improve function in people with in Spinocerebellar Ataxia Type 1 (SCA1)?
Scientific title
The effect of cerebellar transcranial direct current stimulation on ataxia in people with SCA1: A pilot randomised cross-over trial
Secondary ID [1] 305507 0
Nil Known
Universal Trial Number (UTN)
U1111-1268-7184
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinocerebellar Ataxia type 1 323898 0
Condition category
Condition code
Neurological 321411 321411 0 0
Neurodegenerative diseases
Physical Medicine / Rehabilitation 323080 323080 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study involves participants completing 12 intervention sessions (exercise based standardised rehabilitation sessions+anodal tDCS) over a 4 week period (ie., 3 sessions per week). Each exercise based session will take up to 1 hour and will be delivered (one-on-one basis) at the physiotherapy clinic or participant's home, as required. The exercise based session will comprise of a tailored exercise programme aimed at improving postural control, gait speed and dual task performance in complex gait and balance tasks done under supervision of an experienced physiotherapist. The exercises will include treadmill walking, upper and lower limb static cycling, bridging, 4 point kneeling, high kneeling, sit to stand, press ups, lateral lunges, standing with feet apart, feet together and tandem standing, ball reach and throws, lower limb stretching etc.
Transcranial direct current stimulation (tDCS) will be delivered using a battery-driven constant-current stimulator from Soterix Medical. Saline soaked sponge electrodes (5cmx7cm) will be used with the anode placed over the cerebellum (2cm below the inion) and the reference electrode (cathode) over the right deltoid muscle (Parazzini et al 2014; Grimaldi et al 2014). Electrodes will be secured using elastic straps. The Soterix tDCS device will be set to deliver a 2mA current (equates to a 0.06mA/cm2) for 20 minutes.
Anodal tDCS at 2mA stimulus will be used in combination with a standardised rehabilitation programme and will be delivered during the first 20 minutes of the rehabilitation program. An independent research assistant will set the tDCS stimulator to ‘sham’ condition or ‘real’ condition.
Adherence to/fidelity of the intervention will be assessed by keeping a record of session attendance and whether the intervention is delivered as per the planned protocol.

There will be a three month washout period between the intervention and control session.
Intervention code [1] 321920 0
Treatment: Devices
Intervention code [2] 323119 0
Treatment: Other
Intervention code [3] 323120 0
Rehabilitation
Comparator / control treatment
The control treatment will include the exercise based standardised rehabilitation sessions combined with sham tDCS (12 sessions over 4 weeks). The control treatment will be carried out in the same way as the intervention, except that the participant will receive sham tDCS and not the real tDCS stimulation (the delivery of current will ramp up and down at the beginning of the stimulation time for 30s and again at the end of the stimulation time). Participants will feel the ‘tingle’ of stimulation but with a stimulation duration too short to induce after-effects.
Control group
Active

Outcomes
Primary outcome [1] 329202 0
Ataxia assessed using Scale for Assessment and Rating of Ataxia (SARA).
Timepoint [1] 329202 0
Participants will be assessed at baseline (Ax1), then immediately following the first block of intervention (Ax2), again prior to commencing the second block of intervention (Ax3) and finally at the end of the second block of intervention (Ax4).
Secondary outcome [1] 401767 0
Spatiotemporal gait measures and gait variability measures in single and dual task measured using a custom-built Gait&Balance (G&B) app that measures spatiotemporal gait parameters. The variability in gait performance can also be calculated from these measures.
Timepoint [1] 401767 0
Participants will be assessed at baseline (Ax1), then immediately following the first block of intervention (Ax2), again prior to commencing the second block of intervention (Ax3) and finally at the end of the second block of intervention (Ax4).
Secondary outcome [2] 401768 0
Postural control measured using the G&B app to record balance during a standardised assessment involving both eyes open and eyes closed conditions.
Timepoint [2] 401768 0
Participants will be assessed at baseline (Ax1), then immediately following the first block of intervention (Ax2), again prior to commencing the second block of intervention (Ax3) and finally at the end of the second block of intervention (Ax4).
Secondary outcome [3] 401769 0
Hand dexterity assessed using the Perdue Pegboard Test.
Timepoint [3] 401769 0
Participants will be assessed at baseline (Ax1), then immediately following the first block of intervention (Ax2), again prior to commencing the second block of intervention (Ax3) and finally at the end of the second block of intervention (Ax4).
Secondary outcome [4] 407407 0
Acceptability of the intervention (exercise based programme and tDCS) assessed by semi-structured interviews. One-on-one interviews, lasting approximately 20-45 minutes, will be audio-recorded and transcribed verbatim.
Timepoint [4] 407407 0
At the end the study i.e., second block of intervention (Ax4).
Secondary outcome [5] 407408 0
Acceptability of the research process assessed by semi-structured interviews. One-on-one interviews, lasting approximately 20-45 minutes, will be audio-recorded and transcribed verbatim.
Timepoint [5] 407408 0
At the end the study i.e., second block of intervention (Ax4).
Secondary outcome [6] 407409 0
Intervention and research process safety monitored by adverse event assessment. Participants will be asked at the start of each session if they are experiencing any new symptoms and will also be supervised throughout each session. During the session, adverse events that are deemed to be ‘negative symptoms’ of physical therapy exercise (e.g., pain, dizziness) will be recorded on the data collection sheet and the intervention will be adjusted accordingly. At the end of the session, any adverse events that are deemed to be unrelated to the exercise, or that have not resolved by the end of the intervention session, will be recorded on an Adverse Events Form by the supervising physiotherapist and/or researcher.
Timepoint [6] 407409 0
Beginning, during and end of each session.
Secondary outcome [7] 407411 0
Recruitment rate assessed by monitoring clinic admissions to calculate how many SCA1 participants are recruited per month and how many SCA1 participants are admitted per month.
Timepoint [7] 407411 0
Each month for 6 month recruitment period

Eligibility
Key inclusion criteria
Ten participants aged between 18 and 70 with confirmed SCA1 will be recruited through the Neurogenetics Research Clinic.
Inclusion criteria:
• confirmed genetic test
• independently mobile with or without walking aids (able to walk 10m)
• able to give consent,
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• do not have any medical conditions such as epilepsy, unexplained recurring headaches and cardiac arrhythmias which may influence the results
• do not have history of epilepsy, head injury or concussion in the last six months
• do not have a skull fracture or other known skull defects
• do not have any metal implants or pacemakers
• do not have migraine headaches or Meniere’s disease

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)
Participants will undergo random allocation by holder of the allocation scheduler, Biostatistician who is off-site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SCA1 is a rare neurological condition, an important question is the rate of recruitment for future trials, so we will monitor clinic admissions to calculate a monthly rate of SCA1 participants and from this calculate possible recruitment rates for the future study.
As none of the analyses are powered, statistical significance will not be meaningful. Therefore, using a standardized effect size (partial r-squared), the size of the carry over effect will be compared to the size of the intervention effect. A small relative size (< 5%) of the carry-over effect will indicate the adequacy of the washout period for the proposed interventions. Means and 95% confidence intervals estimated from the models will be reported for the outcome measures. Sample size calculations will also be reported for the outcome measures by running simulations on the statistical models. Model assumptions including normality and homogeneity of residuals, linear relation between pre- and post-intervention scores and proportional odds will be evaluated and reported.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/04/2022
Actual
Date of last participant enrolment
Anticipated
17/10/2022
Actual
Date of last data collection
Anticipated
28/02/2023
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 24202 0
New Zealand
State/province [1] 24202 0

Funding & Sponsors
Funding source category [1] 309867 0
Charities/Societies/Foundations
Name [1] 309867 0
Neuromuscular research New Zealand
Country [1] 309867 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Private Bag 92006
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 311004 0
None
Name [1] 311004 0
Address [1] 311004 0
Country [1] 311004 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309603 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 309603 0
Ethics committee country [1] 309603 0
New Zealand
Date submitted for ethics approval [1] 309603 0
01/11/2021
Approval date [1] 309603 0
24/03/2022
Ethics approval number [1] 309603 0
2022 FULL 11080

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

Contacts
Principal investigator
Name 114734 0
Mrs Julie Rope
Address 114734 0
Rope Neuro Rehabilitation Ltd
Unit 6
19 Edwin Street
Mt Eden
Auckland
1024
Country 114734 0
New Zealand
Phone 114734 0
+64 21753279
Fax 114734 0
Email 114734 0
[email protected]
Contact person for public queries
Name 114735 0
Julie Rope
Address 114735 0
Rope Neuro Rehabilitation Ltd
Unit 6
19 Edwin Street
Mt Eden
Auckland
1024
Country 114735 0
New Zealand
Phone 114735 0
+64 21753279
Fax 114735 0
Email 114735 0
[email protected]
Contact person for scientific queries
Name 114736 0
Julie Rope
Address 114736 0
Rope Neuro Rehabilitation Ltd
Unit 6
19 Edwin Street
Mt Eden
Auckland
1024
Country 114736 0
New Zealand
Phone 114736 0
+64 21753279
Fax 114736 0
Email 114736 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying published results will be shared.
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
clinicians and researchers and patients who request it
Available for what types of analyses?
Meta-analyses
How or where can data be obtained?
contacting [email protected]


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.