Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000197538
Ethics application status
Approved
Date submitted
16/01/2024
Date registered
29/02/2024
Date last updated
23/06/2024
Date data sharing statement initially provided
29/02/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
PREP3: Evaluating whether predictions for upper limb motor outcome after stroke can be improved using non-invasive brain stimulation
Scientific title
PREP3: A compositional neurophysiological biomarker for predicting upper limb motor outcome after stroke.
Secondary ID [1] 311304 0
HRC 23/374
Universal Trial Number (UTN)
Trial acronym
PREP3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 332550 0
Condition category
Condition code
Stroke 329239 329239 0 0
Ischaemic
Stroke 329240 329240 0 0
Haemorrhagic

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The recovery of upper limb movement will be observed from within 1 week of stroke until 6 months post-stroke. Information about the participant’s index stroke will be collected from their medical records. Participants within 1 week of stroke will compete the Fugl-Meyer Upper Extremity and the Action Research Arm Test to assess upper limb impairment and activity limitation, respectively, as well as the Oxford Cognitive Screen to assess cognition. Within 1 week of stroke participants will receive non-invasive brain stimulation in the form of transcranial magnetic stimulation. Transcranial magnetic stimulation involves non-invasively stimulating the ipsilesional primary motor cortex to assess functional connectivity of the participant’s corticospinal tract. Responses to transcranial magnetic stimulation are recorded as motor evoked potentials from two hand and two forearm muscles using electromyography. There are no treatment effects from the transcranial magnetic stimulation used in this study. The transcranial magnetic stimulation protocol for this study will only be performed with participants in this study. All together the assessments within 1 week of stroke are expected to take approximately 75 minutes. Follow up assessments will be performed at 3 and 6 months post-stroke. The 3 month post-stroke assessment is the primary end-point for the study and is expected to take approximately 30 minutes. The 3 month post-stroke assessment includes the Fugl-Meyer Upper Extremity and the Action Research Arm Test, as well as the modified Rankin Scale to assess the participant’s level of functional independence. The 6 months post-stroke assessment is expected to take approximately 45 minutes and includes the same assessments as the 3 month post-stroke assessment while adding the Stroke Impact Scale to assess the participant's quality of life.
Intervention code [1] 327750 0
Not applicable
Comparator / control treatment
No control group as study is obervational
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337073 0
The primary outcome measure is the total Action Research Arm Test score, which is a measure of upper limb activity limitation, at 3 months post-stroke. The Action Research Arm Test assesses the ability of the paretic upper limb to perform gross, grasp, pinch, and grip tasks. The total Action Research Arm Test is calculated by adding the scores from the gross, grasp, pinch, and grip tasks together.
Timepoint [1] 337073 0
The primary outcome measure is the total Action Research Arm Test score at 3 months post-stroke.
Secondary outcome [1] 430583 0
A secondary outcome measure is the total Action Research Arm Test score, which is a measure of upper limb activity limitation, at 6 months post-stroke. The Action Research Arm Test assesses the ability of the paretic upper limb to perform gross, grasp, pinch, and grip tasks. The total Action Research Arm Test is scored out of 57 and is calculated by adding the scores from the gross, grasp, pinch, and grip tasks together.
Timepoint [1] 430583 0
A secondary outcome measure is the total Action Research Arm Test score at 6 months post-stroke.
Secondary outcome [2] 430584 0
Separate secondary outcomes are the Fugl-Meyer Upper Extremity score, which is a measure of upper limb activity impairment, at 3 and 6 months post-stroke. The Fugl-Meyer Upper Extremity assesses the ability of the paretic upper limb to perform movements compared to the non-paretic upper limb.
Timepoint [2] 430584 0
The Fugl-Meyer Upper Extremity score will be obtained at 3 and 6 months post-stroke as two separate secondary outcomes.
Secondary outcome [3] 430585 0
The Modified Rankin Scale score at 6 months post-stroke will be used to assess the participant's functional independence. The Modified Rankin Scale includes questions regarding what everyday activities are impacted by the stroke and what symptoms the participant currently has.
Timepoint [3] 430585 0
The Modified Rankin Scale score will be obtained at 6 months post-stroke as a secondary outcome.
Secondary outcome [4] 430586 0
The Stroke Impact Scale score at 6 months post-stroke will be used to assess the participant's quality of life. The Stroke Impact Scale includes questions regarding how the stroke has affected the participant's quality of life.
Timepoint [4] 430586 0
The Stroke Impact Scale score will be obtained at 6 months post-stroke as a secondary outcome.

Eligibility
Key inclusion criteria
Aged 18 or over
Ischaemic or haemorrhagic stroke within the previous week as determined by the patient's clinical team
Upper limb weakness from the index stroke
First-ever stroke or previous stroke with no upper limb weakness
Ability to provide informed consent
SAFE score less than 10 on day 3 post-stroke
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No upper limb weakness from the index stroke
Cerebellar stroke
Subarachnoid haemorrhage
Cognitive or communication impairments that prevents informed consent
Contraindications to transcranial magnetic stimulation
Pre-existing conditions precluding informed consent or compliance with study assessments
Inability to complete upper limb assessments
Terminal illness with life expectancy less than 12 months
Residing out-of-area precluding follow-up assessments
Social or personal circumstances that interfere with ability to perform follow-up assessments

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2024
Actual
26/02/2024
Date of last participant enrolment
Anticipated
15/12/2025
Actual
Date of last data collection
Anticipated
15/06/2026
Actual
Sample size
Target
150
Accrual to date
12
Final
Recruitment outside Australia
Country [1] 26075 0
New Zealand
State/province [1] 26075 0
Auckland

Funding & Sponsors
Funding source category [1] 315558 0
Government body
Name [1] 315558 0
Health Research Council
Country [1] 315558 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Country
New Zealand
Secondary sponsor category [1] 317650 0
None
Name [1] 317650 0
Address [1] 317650 0
Country [1] 317650 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314457 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 314457 0
133 Molesworth Street, Wellington, 6011
Ethics committee country [1] 314457 0
New Zealand
Date submitted for ethics approval [1] 314457 0
12/10/2023
Approval date [1] 314457 0
30/10/2023
Ethics approval number [1] 314457 0

Summary
Brief summary
Up to 150 participants will be recruited within 1 week of stroke onset over a 2.5 year period. Demographic and stroke characteristics will be collected at the time of recruitment. Approximately one week after stroke basic clinical assessments will be carried out evaluating participants' hand and arm movements. Transcranial Magnetic Stimulation (TMS) is a non-invasive technique that will be used to evaluate the motor pathways of the affected upper limb within the first week of stroke.

Follow-up clinical assessments of hand and arm movement will be performed at 3 and 6 months post-stroke. Questionnaires of the participant's level of disability and health-related quality of life will be administered at 6 months post-stroke.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131650 0
Prof Winston Byblow
Address 131650 0
University of Auckland, 368 Khyber Pass, New Market 1023, Auckland
Country 131650 0
New Zealand
Phone 131650 0
+64 93737599
Fax 131650 0
Email 131650 0
w.byblow@auckland.ac.nz
Contact person for public queries
Name 131651 0
Dr Winston Byblow
Address 131651 0
University of Auckland, 368 Khyber Pass, New Market 1023, Auckland
Country 131651 0
New Zealand
Phone 131651 0
+64 93737599
Fax 131651 0
Email 131651 0
w.byblow@auckland.ac.nz
Contact person for scientific queries
Name 131652 0
Dr Winston Byblow
Address 131652 0
University of Auckland, 368 Khyber Pass, New Market 1023, Auckland
Country 131652 0
New Zealand
Phone 131652 0
+64 93737599
Fax 131652 0
Email 131652 0
w.byblow@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data collected during the trial after de-identification
When will data be available (start and end dates)?
Following publication with no end date
Available to whom?
Researchers who provide a methodologically sound proposal
Available for what types of analyses?
Any purpose upon reasonable request
How or where can data be obtained?
Access will be subject to approvals by the Principal Investigator Prof. Winston Byblow who can be contacted at w.byblow@auckland.ac.nz.


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.