Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001067268
Ethics application status
Approved
Date submitted
11/12/2009
Date registered
14/12/2009
Date last updated
2/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Priming the stroke affected motor cortex with theta burst stimulation
Scientific title
Does theta burst stimulation prior to upper limb physiotherapy improve Action Research Arm Test score in chronic stroke patients after two weeks of daily therapy sessions, compared to sham theta burst stimulation prior to upper limb physiotherapy?
Secondary ID [1] 1193 0
None
Universal Trial Number (UTN)
None
Trial acronym
PRIMING2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 252381 0
Condition category
Condition code
Neurological 256562 256562 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Non-invasive transcranial magnetic stimulation will be delivered in a protocol called theta burst stimulation. This protocol involves a 2 second train of low intensity stimuli, repeated every 10 seconds for 192 seconds (600 stimuli in total). This protocol will be delivered prior to an upper limb physiotherapy session, 5 days per week for 2 weeks. Each physiotherapy session will be one-on-one with a registered physiotherapist, last approximately 45 minutes, and will be tailored to the individual's needs and goals.
Intervention code [1] 255682 0
Treatment: Other
Intervention code [2] 255683 0
Rehabilitation
Comparator / control treatment
Sham theta burst stimulation of ipsilesional primary motor cortex prior to each therapy session. A special 'sham' stimulation coil is used, which makes the same sound but does not produce any magnetic stimulation.
Control group
Placebo

Outcomes
Primary outcome [1] 257451 0
Action Research Arm Test score, which measures hand and arm function in everyday tasks.
Timepoint [1] 257451 0
4 weeks after the conclusion of the intervention
Secondary outcome [1] 262602 0
Nine hole peg test score, which measures manual dexterity and coordination.
Timepoint [1] 262602 0
4 weeks after the conclusion of the intervention

Eligibility
Key inclusion criteria
One stroke within previous 6 to 36 months
Upper limb impairment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Epilepsy
Cardiac pacemaker
History of more than one stroke

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 be enrolled by the lead investigator, and their details passed to an associate investigator who will be responsible for randomising them using a minimisation procedure described below. The associate investigator will be responsible for delivering the theta burst stimulation (TBS) intervention, and is the only person who will know which intervention (treatment or control) they are delivering. Participants and all other investigators will remain blinded to allocation, and allocation is concealed from all other investigators.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised using custom software to minimise differences between the treatment and control groups in age, time since stroke, and corticospinal tract integrity.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2010
Actual
3/06/2010
Date of last participant enrolment
Anticipated
Actual
27/11/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
18
Recruitment outside Australia
Country [1] 2361 0
New Zealand
State/province [1] 2361 0

Funding & Sponsors
Funding source category [1] 256166 0
Charities/Societies/Foundations
Name [1] 256166 0
Neurological Foundation of New Zealand
Country [1] 256166 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Neurology Research Unit
Department of Medicine
Centre for Brain Research
University of Auckland
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 251509 0
None
Name [1] 251509 0
Address [1] 251509 0
Country [1] 251509 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258271 0
Health and Disability Ethics Committee Northern Region X
Ethics committee address [1] 258271 0
Ethics committee country [1] 258271 0
New Zealand
Date submitted for ethics approval [1] 258271 0
20/12/2009
Approval date [1] 258271 0
18/02/2010
Ethics approval number [1] 258271 0

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

Contacts
Principal investigator
Name 30610 0
A/Prof Cathy Stinear
Address 30610 0
Department of Medicine
University of Auckland
Private Bag 92019
Auckland
Country 30610 0
New Zealand
Phone 30610 0
+6493737999
Fax 30610 0
Email 30610 0
c.stinear@auckland.ac.nz
Contact person for public queries
Name 13857 0
Cathy Stinear
Address 13857 0
Centre for Brain Research
University of Auckland
Private Bag 92019
Auckland 1142
Country 13857 0
New Zealand
Phone 13857 0
+64 9 92 33 779
Fax 13857 0
Email 13857 0
c.stinear@auckland.ac.nz
Contact person for scientific queries
Name 4785 0
Cathy Stinear
Address 4785 0
Centre for Brain Research
University of Auckland
Private Bag 92019
Auckland 1142
Country 4785 0
New Zealand
Phone 4785 0
+64 9 92 33 779
Fax 4785 0
Email 4785 0
c.stinear@auckland.ac.nz

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.