Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000597493
Ethics application status
Not yet submitted
Date submitted
14/11/2007
Date registered
20/11/2007
Date last updated
19/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Targeted therapy to improve outcomes following stroke
Scientific title
Targeted neuromodulation with Transcranial Direct Current Stimulation to improve upper limb motor function following stroke.
Secondary ID [1] 295604 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 2547 0
Condition category
Condition code
Neurological 2647 2647 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Anodal and cathodal Transcranial Direct Current Stimulation (in separate sessions separated by at least 1 week) delivered to primary motor cortex via surface electrodes, for 20 minutes at an intensity of 1 milliamp.
Intervention code [1] 2279 0
Treatment: Other
Comparator / control treatment
Sham Transcranial Direct Current Stimulation, which will be 20 minutes of sham stimulation with zero milliamps intensity, delivered to primary motor cortex via surface electrodes. As for the 2 treatment sessions, the sham session will be separated from all other sessions by at least 1 week.
Control group
Placebo

Outcomes
Primary outcome [1] 3558 0
Upper limb function as assessed by a blinded clinical assessor with the Action Research Arm Test
Timepoint [1] 3558 0
Immediately prior to, and following, administration
Secondary outcome [1] 5956 0
Grip and load forces during a precision grip-lift task.
Timepoint [1] 5956 0
Immediately prior to, and following, administration
Secondary outcome [2] 5957 0
Primary motor cortex excitability, assessed with transcranial magnetic stimulation
Timepoint [2] 5957 0
Immediately prior to, and following, administration

Eligibility
Key inclusion criteria
First ever monohemispheric stroke between 6 and 12 weeks prior to inception
Upper limb weakness
National Institutes of Health Stroke Scale score between 2 and 16 at inception
Medically stable
Ambulatory
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindications to Transcranial Magnetic Stimulation or Magnetic Resonance Imaging
Medications known to alter neural excitability
Cognitive impairment precluding informed consent

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)
Researchers will screen potential participants for eligibility, using the stated inclusion/exclusion criteria. Eligible volunteers will then provide their written informed consent. The researchers will then contact the study coordinator, who is at a central administration site. The study coordinator will then randomise the session order for each participant, using custom computer software. The session order will remain concealed from the researchers and participants. Participants will receive anodal TDCS, cathodal TDCS, and sham TDCS in 3 separate sessions, at least one week apart.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The session order for each participant will be randomised and counterbalanced by the study coordinator using customised software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
The type of intervention delivered in each session will be controlled by customised software, programmed by the study coordinator, in such a way that the other researchers and participant cannot know which intervention is being delivered.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
This project did not go ahead, and no participants were recruited
Date of first participant enrolment
Anticipated
1/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 654 0
New Zealand
State/province [1] 654 0
Country [2] 655 0
New Zealand
State/province [2] 655 0

Funding & Sponsors
Funding source category [1] 2792 0
University
Name [1] 2792 0
University of Auckland
Country [1] 2792 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Auckland
Country
New Zealand
Secondary sponsor category [1] 2522 0
None
Name [1] 2522 0
Address [1] 2522 0
Country [1] 2522 0
Other collaborator category [1] 87 0
Individual
Name [1] 87 0
Dr P Alan Barber
Address [1] 87 0
Neurology
Auckland City Hospital
Auckland
Country [1] 87 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4711 0
Northern Region Ethics Committee
Ministry of Health
Ethics committee address [1] 4711 0
Ethics committee country [1] 4711 0
New Zealand
Date submitted for ethics approval [1] 4711 0
01/11/2007
Approval date [1] 4711 0
Ethics approval number [1] 4711 0
Ethics committee name [2] 4730 0
Ethics committee address [2] 4730 0
Ethics committee country [2] 4730 0
Date submitted for ethics approval [2] 4730 0
01/11/2007
Approval date [2] 4730 0
Ethics approval number [2] 4730 0

Summary
Brief summary
Following stroke, the side of the brain affected by the stroke is often under-active. This may limit its ability to recover function. The purpose of this study is to see whether the activity of the stroke-affected side of the brain can be increased, using a technique called Transcranial Direct Current Stimulation (TDCS). TDCS is a safe, non-invasive and painless way of altering the activity levels of neurons in the brain. This study will trial 3 different TDCS protocols, to see which is the most effective at producing a short-term increase in the activity of the stroke-affected side of the brain. In particular, the speed and skill of hand movements will be measured before and after a 20 minute period of TDCS, in addition to other neurophysiological measures of brain activity. Our hypothesis is that TDCS can be individually targeted, based on the parts of the brain affected by stroke, in a way that may enhance the benefits of physical therapy. If we find that TDCS is effective, this may lead to a larger scale trial, integrating TDCS with physical therapy, where it may improve functional outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28182 0
A/Prof Cathy Stinear
Address 28182 0
Department of Medicine, University of Auckland
Private Bag 92019
Country 28182 0
New Zealand
Phone 28182 0
+6499233779
Fax 28182 0
Email 28182 0
[email protected]
Contact person for public queries
Name 11339 0
A/Prof Dr Cathy Stinear
Address 11339 0
Department Sport & Exercise Science
University of Auckland
Private Bag 92019
Auckland
Country 11339 0
New Zealand
Phone 11339 0
+64 9 3737599 ext. 83766
Fax 11339 0
Email 11339 0
[email protected]
Contact person for scientific queries
Name 2267 0
Prof Associate Professor Winston Byblow
Address 2267 0
Department Sport & Exercise Science
University of Auckland
Private Bag 92019
Auckland
Country 2267 0
New Zealand
Phone 2267 0
+64 9 3737599 ext. 86844
Fax 2267 0
Email 2267 0
[email protected]

No information has been provided regarding IPD availability


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.