Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000740695
Ethics application status
Approved
Date submitted
26/09/2005
Date registered
11/11/2005
Date last updated
11/11/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Recovery of hand function following stroke
Scientific title
Theta Burst Stimulation to promote balanced brain activity following stroke
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 892 0
Condition category
Condition code
Stroke 960 960 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Magnetic brain stimulation applied for up to two minutes, once per week, for up to 5 weeks.
Intervention code [1] 675 0
Rehabilitation
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 1270 0
Motor cortex excitability
Timepoint [1] 1270 0
Immediately following, and up to 40 minutes after intervention.
Primary outcome [2] 1271 0
Motor cortex function
Timepoint [2] 1271 0
Immediately following, and up to 40 minutes after intervention.
Secondary outcome [1] 2302 0
Arm and hand function
Timepoint [1] 2302 0
Immediately following, and up to 40 minutes after intervention.

Eligibility
Key inclusion criteria
First-ever monohemispheric subcortical stroke at least 3 months prior to enrolment; Upper limb weakness.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindications to transcranial magnetic stimulation and/or magnetic resonance imaging; Unable to walk unassisted; Unable to give 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)
The order of stimulation protocols for each participant is randomly determined using custom software by a researcher who is blinded to data collection and analysis. The researcher responsible for data collection and analysis is blinded to the order of stimulation protocols allocated to each participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random allocation of stimulation protocols is generated by computerized random number generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
All participants receive one â¿¿placeboâ¿¿ session, where sham stimulation is delivered. These sessions serve as control sessions for the other stimulation protocols.
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 236 0
New Zealand
State/province [1] 236 0

Funding & Sponsors
Funding source category [1] 1058 0
Name [1] 1058 0
Country [1] 1058 0
Primary sponsor type
University
Name
The University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 919 0
None
Name [1] 919 0
Not applicable
Address [1] 919 0
Country [1] 919 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35374 0
Address 35374 0
Country 35374 0
Phone 35374 0
Fax 35374 0
Email 35374 0
Contact person for public queries
Name 9864 0
Dr Cathy Stinear
Address 9864 0
Human Motor Control Laboratory
Department of Sport and Exercise Science
University of Auckland
Privage Bag 92019
Auckland
Country 9864 0
New Zealand
Phone 9864 0
+64 9 3737599 ext. 83766
Fax 9864 0
Email 9864 0
[email protected]
Contact person for scientific queries
Name 792 0
Associate Professor Winston Byblow
Address 792 0
Human Motor Control Laboratory
Department of Sport and Exercise Science
University of Auckland
Privage Bag 92019
Auckland
Country 792 0
New Zealand
Phone 792 0
+64 9 3737599 ext. 86844
Fax 792 0
Email 792 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.