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Trial registered on ANZCTR


Registration number
ACTRN12613000641796
Ethics application status
Approved
Date submitted
31/05/2013
Date registered
6/06/2013
Date last updated
6/06/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Theta-burst stimulation as an adjuvant to treatment of upper limb spasticity in stroke: a pilot study
Scientific title
Theta-burst stimulation as an adjuvant to treatment of upper limb spasticity in stroke: a pilot study
Secondary ID [1] 282599 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper limb spasticity in stroke survivors 289293 0
Condition category
Condition code
Stroke 289619 289619 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will consist of theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (TMS). TBS will be delivered at a low intensity (80% of active motor threshold of the target muscle) with a 90 mm wing diameter, figure of 8 flat coil connected to a Magstim Rapid 2 stimulator (MagStim Co., Whitland, Dyfed, Wales). The paradigm consists of 10 bursts of triplets of pulses (50 Hz) applied at 5 Hz every 10 seconds, a total of 600 pulses. The stimulation will not take longer than a total of 3 minutes. Participants will receive TBS to the ipsilesional hemisphere four times a week for two weeks.
Intervention code [1] 287268 0
Treatment: Devices
Comparator / control treatment
Sham theta burst stimulation.
The paradigm of the sham intervention is identical to the TBS intervention paradigm (10 bursts of triplets of pulses every 10 seconds, a total of 600 pulses). Sham TBS will be applied with a sham coil identical to the real coil that generates the same noise but does not emit a magnetic pulse to maintain blinding. Like in the TBS intervention group the control group will receive sham TBS to the ipsilesional hemisphere four times a week for two weeks and each session will not take longer than a total of 3 minutes.
Control group
Placebo

Outcomes
Primary outcome [1] 289705 0
Tardieu Scale immediately post-intervention
Timepoint [1] 289705 0
Immediately post-intervention period
Primary outcome [2] 289706 0
Box and Block Test immediately post-intervention
Timepoint [2] 289706 0
Immediately post-intervention period
Secondary outcome [1] 303055 0
Tardieu Scale at 2 weeks post-intervention
Timepoint [1] 303055 0
2 weeks post-intervention period
Secondary outcome [2] 303056 0
Box and Block Test at 2 weeks post-intervention
Timepoint [2] 303056 0
2 weeks post-intervention period
Secondary outcome [3] 303057 0
EuroQol Quality of Life Scale
Timepoint [3] 303057 0
Immediately post-intervention period
2 weeks post-intervention period
Secondary outcome [4] 303058 0
Stroke Impact Scale
Timepoint [4] 303058 0
Immediately post-intervention period
2 weeks post-intervention period
Secondary outcome [5] 303059 0
TMS measurements: amplitude of motor evoked potential (MEP) from the target muscle, ipsilateral silent period (ISP), recruitment curve.
Timepoint [5] 303059 0
Immediately post-intervention period
2 weeks post-intervention period

Eligibility
Key inclusion criteria
History of stroke at least 12 months before the recruitment into the study
Spasticity of moderate severity (Modified Ashworth Score = 3) in at least one upper limb
No contraindications to TMS or TBS
No other neurological or musculoskeletal disorders affecting the cervical spine.
Concurrent treatment with botulinum toxin
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with cognitive deficits and patients unable to reliably follow instructions
Patients with unstable cardiac dysrhythmias, pacemakers etc
Patients with history of seizure(s) or family history of seizures in first degree relatives
Patients who have undergone brain surgery or had brain trauma
Patients with history of intracranial hypertension
Patients using tranquilizers or medications that can alter the seizure threshold unless they are able to cease the medications at least two weeks period to the stimulation
Patients with intracranial metallic, magnetic pieces, with pacemakers or any other device
Any other coexisting neurological or musculoskeletal condition that can result in contracture, spasticity or hypertonia

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)
Subjects will be allocated to a group by an independent investigator using a minimisation process to ensure comparable groups. Allocation will be concealed from investigators performing outcome measurements as interventions are delivered separately to outcome measures. Allocation will be concealed from subjects by use of a sham TMS coil.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer randomisation program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 24 participants was established using the confidence interval approach. The research questions will be assessed using an intention-to-treat approach. Independent samples t-tests, Mann-Whitney U tests and Chi-square test of association will be used as appropriate to compare groups at baseline. To determine differences between the groups at the primary end-point, ANOVA or logistic regression will be used with models adjusted according to potential confounders.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/06/2013
Actual
Date of last participant enrolment
Anticipated
31/05/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 1070 0
Repatriation Hospital - Daw Park

Funding & Sponsors
Funding source category [1] 287381 0
Charities/Societies/Foundations
Name [1] 287381 0
The Repat Foundation
Country [1] 287381 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
In care of:
Daws Road, Daw Park
South Australia, 5041
Country
Australia
Secondary sponsor category [1] 286128 0
Hospital
Name [1] 286128 0
Repatriation General Hospital
Address [1] 286128 0
Daws Road, Daw Park
South Australia, 5041
Country [1] 286128 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289355 0
Southern Adelaide Clinical Research Ethics Committee
Ethics committee address [1] 289355 0
The Flats, G5 - Rooms 3 and 4
Flinders Drive
Flinders Medical Centre
Bedford Park
SA 5042
Ethics committee country [1] 289355 0
Australia
Date submitted for ethics approval [1] 289355 0
Approval date [1] 289355 0
20/03/2013
Ethics approval number [1] 289355 0
37.13

Summary
Brief summary
Spasticity affects more than half of stroke survivors and can severely impact on functional independence, quality of life and caregiver burden.Recently non-invasive brain stimulation (NIBS) has been proposed as an alternative approach to promote the recovery of motor impairments after stroke. This type of intervention aims to alter brain excitability and may have potential as a therapeutic intervention to enhance neuroplasticity after stroke. There may be benefits in combining this novel intervention with standard therapies. Therefore in this study we will assess the effect of NIBS on upper limb spasticity in individuals with stroke concurrently treated with botulinum toxin. We anticipate that this study will guide us to develop a novel intervention program to improve spasticity in stroke survivors and in turn motor control and upper limb function.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40442 0
Dr Maayken van den Berg
Address 40442 0
Flinders University
School of Medicine, Dep of Rehabilitation, Aged & Extended Care
Repatriation General Hospital, Daws Road, Daw Park
South Australia 5041
Country 40442 0
Australia
Phone 40442 0
+61 (08) 8275 1297
Fax 40442 0
Email 40442 0
[email protected]
Contact person for public queries
Name 40443 0
Maayken van den Berg
Address 40443 0
Flinders University
School of Medicine, Dep of Rehabilitation, Aged & Extended Care
Repatriation General Hospital, Daws Road, Daw Park
South Australia 5041
Country 40443 0
Australia
Phone 40443 0
+61 (08) 8275 1297
Fax 40443 0
Email 40443 0
[email protected]
Contact person for scientific queries
Name 40444 0
Maayken van den Berg
Address 40444 0
Flinders University
School of Medicine, Dep of Rehabilitation, Aged & Extended Care
Repatriation General Hospital, Daws Road, Daw Park
South Australia 5041
Country 40444 0
Australia
Phone 40444 0
+61 (08) 8275 1297
Fax 40444 0
Email 40444 0
[email protected]

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