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Trial registered on ANZCTR


Registration number
ACTRN12614000611628
Ethics application status
Approved
Date submitted
1/06/2014
Date registered
6/06/2014
Date last updated
8/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The feasibility of combining transcranial direct current stimulation with rehabilitation of the hand and arm after stroke, and its effects on rate of recovery
Scientific title
The effects of transcranial direct current stimulation on the rate of recovery of upper limb function measured with the Action Research Arm Test in patients with first-ever monohemispheric ischaemic stroke: a randomised, blinded, sham-controlled, feasibility study.
Secondary ID [1] 284706 0
None
Universal Trial Number (UTN)
Trial acronym
FASTER: Feasibility of Accelerating STrokE Recovery
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 292064 0
Condition category
Condition code
Stroke 292402 292402 0 0
Ischaemic
Physical Medicine / Rehabilitation 292432 292432 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transcranial direct current stimulation will be applied for 20 minutes, no more than once per day, during upper limb therapy sessions. These sessions may be daily, or less frequently, depending on the rehabilitation programme devised for each participant by the therapy team. The anode will be positioned over the stroke-affected primary motor cortex. The cathode will be positioned over the opposite primary motor cortex. The stimulus intensity will be up to 2 mA. Stimulation will be delivered using a HDCStim unit and cap. TDCS will be added to therapy sessions until the participant is discharged from rehabilitation, or reaches 6 weeks post-stroke, whichever occurs first.
Intervention code [1] 289497 0
Rehabilitation
Intervention code [2] 289519 0
Treatment: Devices
Comparator / control treatment
Sham transcranial direct current stimulation, delivered using the same equipment and with the same protocol. The stimulation intensity will be ramped up over the first 30 seconds and then switched off.
Control group
Placebo

Outcomes
Primary outcome [1] 292263 0
Rate of change in upper limb function, measured with weekly administration of the Action Research Arm Test.
Timepoint [1] 292263 0
Six weeks post-stroke.
Secondary outcome [1] 308586 0
Rate of change in upper limb impairment, measured with weekly administration of the Fugl-Meyer Scale.
Timepoint [1] 308586 0
Six weeks post-stroke.
Secondary outcome [2] 308587 0
Compliance by therapists and patients, measured as the proportion of upper limb therapy sessions that included TDCS.
Timepoint [2] 308587 0
Six weeks post-stroke.
Secondary outcome [3] 308588 0
Disability measured with the modified Rankin Scale.
Timepoint [3] 308588 0
Nine and twelve weeks post-stroke
Secondary outcome [4] 308589 0
Stroke-related quality of life measured with the Stroke Impact Scale.
Timepoint [4] 308589 0
Nine and twelve weeks post-stroke.

Eligibility
Key inclusion criteria
First-ever mono-hemispheric ischaemic stroke within the previous 2 weeks.
Requiring upper limb rehabilitation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cerebellar stroke.
Contraindications to TDCS, which are: metal implants in the head (other than dental fillings); cardiac pacemaker; history of epilepsy; pregnancy.
Cognitive or communication impairment precluding informed consent.
Unable to produce at least 10 degrees voluntary extension of the paretic wrist or fingers without gravity.

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)
Patients admitted to rehabilitation will be screened by a research coordinator. Those meeting the inclusion criteria will be approached. Those who consent to participation will be enrolled and complete baseline assessments (Action Research Arm Test, Fugl-Meyer Scale, National Institutes of Health Stroke Scale).
Personal, clinical and demographic details for each enrolled participant will be securely sent to an off-site researcher responsible for randomisation. Participants will be randomised using custom software that will also minimise between-group differences in age and baseline upper limb impairment (Fugl-Meyer score) and baseline stroke severity (National Institutes of Health Stroke Scale score).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
We estimate that each of the two study sites will be able to recruit up to 15 patients within the 12 month study period, for a total of 30 participants. With this sample size, alpha = 0.05, beta = 0.80, and an estimated standard deviation of the recovery rate of 2 ARAT points per week based on our previous work, the study will be powered to detect a difference in recovery rate of 2 ARAT points per week between the real and sham tDCS groups
The primary outcome will be analysed with a two-tailed independent samples t-test of the mean rates of upper limb recovery for the real and sham TDCS groups. Regression analyses will also be carried out for ARAT score to explore the effects of group and time, while controlling for therapy dose and initial ARAT score. These analyses will be repeated for FM score. The effects of tDCS on disability and quality of life will be examined with RM-ANOVA of modified Rankin and Stroke Impact Scale scores, with factors group and time (9 and 12 weeks).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2014
Actual
10/11/2014
Date of last participant enrolment
Anticipated
Actual
26/04/2015
Date of last data collection
Anticipated
Actual
1/11/2015
Sample size
Target
30
Accrual to date
Final
4
Recruitment outside Australia
Country [1] 6087 0
New Zealand
State/province [1] 6087 0

Funding & Sponsors
Funding source category [1] 289328 0
Government body
Name [1] 289328 0
Health Research Council of New Zealand
Country [1] 289328 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Private Bag 92019
Auckland Mail Centre
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 288015 0
Hospital
Name [1] 288015 0
Auckland District Health Board
Address [1] 288015 0
Private Bag 92024
Auckland Mail Centre
Auckland 1142
Country [1] 288015 0
New Zealand
Secondary sponsor category [2] 288016 0
Hospital
Name [2] 288016 0
Counties Manukau District Health Board
Address [2] 288016 0
Private Bag 94052
South Auckland Mail Centre
Manukau 2240
Country [2] 288016 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291094 0
Health and Disability Ethics Committees
Ethics committee address [1] 291094 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 291094 0
New Zealand
Date submitted for ethics approval [1] 291094 0
01/07/2014
Approval date [1] 291094 0
11/08/2014
Ethics approval number [1] 291094 0

Summary
Brief summary
Stroke is a leading cause of long-term adult disability. Advances in neuroscience have led to the development of techniques for promoting neuroplasticity and recovery after stroke. These techniques include transcranial direct current stimulation (tDCS), which is generally accepted to be a safe, painless and promising adjuvant to neurorehabilitation. However, there have been only two studies of its effects on patients engaged in standard rehabilitation at the sub-acute stage, with mixed results. The aims of this feasibility study are to determine whether tDCS can be integrated in clinical practice in New Zealand, and whether it can accelerate the recovery of hand and arm function after stroke.
People who have experienced a stroke in the last 2 weeks, and are now engaged in rehabilitation, may be eligible to take part in this trial. Taking part will involve having real or sham tDCS added to upper limb therapy sessions for the first six weeks of recovery. Hand and arm movements will be assessed weekly for the first six weeks, with follow-up measures made 9 and 12 weeks after stroke.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48862 0
A/Prof Cathy Stinear
Address 48862 0
Department of Medicine
University of Auckland
Private Bag 92019
Auckland 1142
Country 48862 0
New Zealand
Phone 48862 0
+64 9 92 33 779
Fax 48862 0
Email 48862 0
c.stinear@auckland.ac.nz
Contact person for public queries
Name 48863 0
Cathy Stinear
Address 48863 0
Department of Medicine
University of Auckland
Private Bag 92019
Auckland 1142
Country 48863 0
New Zealand
Phone 48863 0
+64 9 92 33 779
Fax 48863 0
Email 48863 0
c.stinear@auckland.ac.nz
Contact person for scientific queries
Name 48864 0
Cathy Stinear
Address 48864 0
Department of Medicine
University of Auckland
Private Bag 92019
Auckland 1142
Country 48864 0
New Zealand
Phone 48864 0
+64 9 92 33 779
Fax 48864 0
Email 48864 0
c.stinear@auckland.ac.nz

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