Stroke Circulatory System
Conditions
Interventions
Current interventions as of 09/07/2026:
Initial screening of potentially eligible participants will include a check of patients' notes to confirm:
1. Evidence of stroke including review of radiology r
Sponsors
University of East Anglia
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 09/07/2026: 1. Aged at least 18 years at the time of consent 2. Stroke confirmed with clinical brain imaging (CT and/or MRI), not neck or brain vessel imaging (CTA, MRA, DSA) 3. Between 1 week and 75 days post-stroke 4. Signs of neglect on at least one of the following: 4.1. Star Cancellation 1 or 3 or 1 or 3 or <-2 6. Able to follow a one-stage command “grasp this pencil/pen with your less affected arm” as demonstrated by another 7. Able to sit with or without support in front of a table for 30 continuous minutes
Exclusion criteria
Exclusion criteria: 1. Being discharged from inpatient hospital facility to home, or to an inpatient hospital facility that is not part of the regional participating hub within the next 7 days 2. Enrolled on another interventional study targeting neglect 3. Limited life expectancy due to another illness or chronic condition making the 3-month follow-up difficult (e.g. widespread malignancy) 4. For mechanistic neuroimaging study only: Contraindications to taking part in the MRI study as assessed by the local MRI safety questionnaire (e.g., non-MRI compatible pacemaker)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neglect measured using the Star Cancellation sub-test of the Behavioural Inattention Test (BIT) at baseline, Day 11 and 12 weeks post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcomes as of 09/07/2026: Measured at baseline, Day 11 and 12 weeks post-randomisation: 1. Neglect measured using the Oxford Cognitive Screen (OCS) cancellation task and the Endpoint weightings line bisection task (LB). Measured only at 12 weeks post-randomisation: 2. Self-reported stroke outcomes will be measured using the Stroke Impact Scale (SIS). Measured only at baseline: 3. Stroke severity determined from data extracted from patients’ notes using the NIH Stroke Scale/Score (NIHSS) 4. Dissociation between grasping and pointing measured using the Perception-Grasping Dissociation task 5. Visual field deficits measured using the visual field assessment sub-test of the Vision Impairment Screening Assessment (VISA) tool 6. Stroke-specific cognitive deficits assessed using the full Oxford Cognitive Screen 7. Apraxia detected using the Gesture Recognition sub-test of the Birmingham Cognitive Screen (BCoS) 8. For sites that are able, the (optional) Computerised Extrapersonal Neglect Test (CENT) will be used to measure neglect for far space, or extrapersonal neglect. 9. Clinical brain imaging scans and reports (CT and/or MRI) will be used to map the stroke lesion location to determine if this impacts therapy response. 10. For those who are able and consent to MRI the following neuroimaging sequences will be acquired to map the stroke lesion and provide a neuroimaging dataset of neglect post-stroke: 10.1. Localisation/setup scans to harmonise the data 10.2. T1-weighted whole-brain scan for alignment 10.3. T2 FLAIR to provide good lesion contract 10.4. Resting-state functional MRI (rsfMRI) to measure changes in blood oxygenation associated with intrinsic brain activity 10.5. Diffusion-weighted imaging scan (DTI) for white matter tractography Previous secondary outcomes: Measured at baseline, Day 11 and 12 weeks post-randomisation: 1. Neglect measured using the Oxford Cognitive Screen (OCS) cancellation task, the Endpoint weightings line bisection tas | — |
Countries
England, United Kingdom
Contacts
Public ContactGregory;Stephanie Howard;Rossit
;
Outcome results
None listed