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PREP3: Evaluating whether predictions for upper limb motor outcome after stroke can be improved using non-invasive brain stimulation

PREP3: A compositional neurophysiological biomarker for predicting upper limb motor outcome after stroke.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12624000197538
Acronym
PREP3
Enrollment
12
Registered
2024-02-29
Start date
2024-02-26
Completion date
2025-12-15
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

University of Auckland
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026