Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000314022
Ethics application status
Approved
Date submitted
14/04/2010
Date registered
20/04/2010
Date last updated
22/06/2021
Date data sharing statement initially provided
22/06/2021
Date results provided
22/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Priming the brain after stroke for a better response to arm training
Scientific title
Sensorimotor integration after theta burst stimulation primed upper-limb training in subcortical stroke patients
Secondary ID [1] 251621 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subcortical Stroke 257164 0
Condition category
Condition code
Stroke 257313 257313 0 0
Ischaemic
Stroke 257353 257353 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Theta burst stimulation (TBS), motor training

TBS is a safe, painless form of patterned repetitive non-invasive brain stimulation. It consists of bursts containing 3 biphasic pulses at 50Hz repeated every 200ms, given intermittently (iTBS) or continuously (cTBS). ITBS (600 stimuli) is applied for 2 seconds on and 8 seconds off, for a total of 192 seconds. CTBS (600 stimuli) is applied continuously for 40 seconds.



TBS is delivered to the scalp overlying the primary motor cortex, applied by an experienced researcher blinded to data collection.

TBS intensity will be 90% of active motor threshold. TBS will take up to 192 secs to deliver. Either iTBS, cTBS or shamTBS will be delivered in a randomised order over three experimental sessions held at least 1 week apart (wash-out period).

5 minutes after TBS (in each of the thrree experimental sessions) the patient will complete 16 minutes of motor training. Motor training consists of four, 4 min blocks. Patients will be required to move pegs in and out of a pegboard. The number of pegs moved will be counted.

There is only one treatment arm, all participants will receive TBS and motor training in each experimental session.
Intervention code [1] 256308 0
Rehabilitation
Intervention code [2] 256309 0
Treatment: Other
Comparator / control treatment
Sham TBS, motor training.


ShamTBS will be applied to either primary motor cortex using a sham coil. The sham coil is identical in appearance to the coil used for actual stimulation. It will be given to mimic either cTBS (over contralesional M1) or iTBS (over ipsilesional M1). The type of shamTBS (shamiTBS or shamcTBS) will be determined randomly for each patient. They will only recieve one form of shamTBS.

The sham coil makes the same audible clicks as real TBS and provides a slight cutaneous sensation, but delivers no stimulation. ShamiTBS will take 192 seconds to deliver and ShamcTBS will take 600 seconds to deliver.

ShamTBS is delivered in one of the three experimental sessions and followed 5 minutes later by motor training (as described previously).
Control group
Placebo

Outcomes
Primary outcome [1] 258218 0
Precision grip function (Preload force and duration) with a customised grip-lift manipulandum
Timepoint [1] 258218 0
Pre and post TBS- and training
Primary outcome [2] 258219 0
Sensorimotor integration with % short-latency afferent inhibition (SAI).


SAI is assessed using transcranial magnetic stimulation (TMS) and peripheral nerve stimulation. Peripheral nerve stimulation will be delivered via a digitial electrode to the index finger of the contralateral hand. The stimulation intensity will be 2 - 3 times perceptual threshold. TMS will be delivered following peripheral stimulation, at an interstimulus interval determined for each individual (25,30 or 40ms).

The pairing of these stimuli results in inhibition of the motor evoked potential (MEP). The MEP is recorded using electromyography. The magnitude of inhibition after TBS and training will be compared to the inhibition recorded at baseline.
Timepoint [2] 258219 0
Pre and post TBS- and training
Primary outcome [3] 258220 0
Change in Action Research Arm Test score
Timepoint [3] 258220 0
Pre and post intervention
Secondary outcome [1] 263876 0
Corticomotor excitability with transcranial magentic stimulation (TMS).


TMS will be delivered over ipsilesional and contralesional M1. Motor evoked potentials will be recorded using electromyography, with electrodes over the first doral interosseous bilaterally. Corticomotor excitability of ipsilesional and contralesional M1 will be determined by averaging contralateral MEP area over 16 stimuli to the affected (cMEPipsi) and non-affected (cMEPcontra) hands.
Timepoint [1] 263876 0
Pre and post TBS- and training

Eligibility
Key inclusion criteria
First-ever subcortical stroke
Upper-limb impairment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neurological problem other than stroke
Cardiac pacemaker
Metal implants
Seizures
Certain types of medication

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2010
Actual
1/05/2010
Date of last participant enrolment
Anticipated
Actual
13/10/2010
Date of last data collection
Anticipated
Actual
4/02/2011
Sample size
Target
18
Accrual to date
Final
13
Recruitment outside Australia
Country [1] 2587 0
New Zealand
State/province [1] 2587 0

Funding & Sponsors
Funding source category [1] 256813 0
Self funded/Unfunded
Name [1] 256813 0
Country [1] 256813 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Department of Sport and Exercise Science
Cnr Morrin and Merton Road
Glen Innes
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 256094 0
None
Name [1] 256094 0
Address [1] 256094 0
Country [1] 256094 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258836 0
Heatlth and Disability Ethics Committee New Zealand
Ethics committee address [1] 258836 0
Ethics committee country [1] 258836 0
New Zealand
Date submitted for ethics approval [1] 258836 0
26/03/2010
Approval date [1] 258836 0
21/04/2010
Ethics approval number [1] 258836 0

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

Contacts
Principal investigator
Name 31052 0
A/Prof Cathy Stinear
Address 31052 0
Univeristy of Auckland
Level 12
Auckland City Hospital
Hospital Support Building
Park Road
Grafton
Auckland 1142
Country 31052 0
New Zealand
Phone 31052 0
+64 9 923 33779
Fax 31052 0
Email 31052 0
[email protected]
Contact person for public queries
Name 14299 0
Suzanne Ackerley
Address 14299 0
Department of Sport and Exercise Science
Private Bag 92010
AUCKLAND 1142
Country 14299 0
New Zealand
Phone 14299 0
+64 9 373 7599 ext 84897
Fax 14299 0
Email 14299 0
[email protected]
Contact person for scientific queries
Name 5227 0
Winston Byblow
Address 5227 0
Department of Sport and Exercise Science
Private Bag 92010
AUCKLAND 1142
Country 5227 0
New Zealand
Phone 5227 0
+64 9 373 7599
Fax 5227 0
Email 5227 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.