ANZCTR - Registration

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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]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Subcortical Stroke

Condition category

Condition code

Stroke

Ischaemic

Stroke

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]

Rehabilitation

Intervention code [2]

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]

Precision grip function (Preload force and duration) with a customised grip-lift manipulandum

Timepoint [1]

Pre and post TBS- and training

Primary outcome [2]

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]

Pre and post TBS- and training

Primary outcome [3]

Change in Action Research Arm Test score

Timepoint [3]

Pre and post intervention

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Heatlth and Disability Ethics Committee New Zealand

Ethics committee address [1]

Ministry of Health
 Health and Disability Ethics Committees
 PO Box 5013
 Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

26/03/2010

Approval date [1]

21/04/2010

Ethics approval number [1]

Summary

Brief summary

Advances in acute medical care have increased survivorship after stroke, but frequently patients are left with disability, commonly including deficits of the motor system. Despite neurorehabilitation, most patients have ongoing impairment six months after stroke, which limits activity and restricts participation in life roles. Upper-limb weakness, in particular, is a major limiting factor in recovery of function. It is important to explore new ways to help improve upper limb recovery following stroke.  

Theta burst stimulation (TBS) of the primary motor cortex can be used to increase or decrease the excitability of the brain (where excitability refers to the responsiveness of neurons in the brain). We have previously shown that priming the brain with TBS, before practising a grip lift task with the affected hand, can improve grip function. We hypothese that TBS allows the primary motor cortex in the stroke affected hemisphere to be more receptive to inputs from the sensory cortex and this in turn allows strengthening and formation of new neural connections during subsequent precision grip training.  We expect that this mechanism explains the observed improvements in performance of the affected hand.

This project therefore aims to extend our previous findings by investigating these hypotheses.  This will provide important knowledge regarding the mechanisms that give rise to behavioural improvements following primed motor training.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Cathy Stinear

Address

Univeristy of Auckland
Level 12
Auckland City Hospital
Hospital Support Building
Park Road
Grafton
Auckland 1142

Country

New Zealand

Phone

+64 9 923 33779

Fax

c.stinear@auckland.ac.nz

Contact person for public queries

Name

Suzanne Ackerley

Address

Department of Sport and Exercise Science
Private Bag 92010
AUCKLAND 1142

Country

New Zealand

Phone

+64 9 373 7599 ext 84897

Fax

s.ackerley@auckland.ac.nz

Contact person for scientific queries

Name

Winston Byblow

Address

Department of Sport and Exercise Science
Private Bag 92010
AUCKLAND 1142

Country

New Zealand

Phone

+64 9 373 7599

Fax

w.byblow@auckland.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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