EyeFocus: Testing an app for improving attention in brain injury survivors
| ISRCTN | ISRCTN16978984 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16978984 |
| Central Portfolio Management System (CPMS) | 64959 |
| National Institute for Health and Care Research (NIHR) | 208955 |
| Sponsor | University of East Anglia |
| Funder | National Institute for Health and Care Research |
- Submission date
- 12/03/2026
- Registration date
- 23/03/2026
- Last edited
- 25/03/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
While physical and language impairments after acquired brain injury (ABI) are seen easily, cognitive effects are often hidden and considered an unmet need. The innovative digital health technology, “EyeFocus”, is directed at one of the most frequent and disabling cognitive impairments in ABI: neglect. Neglect affects 1 in 3 ABI survivors and is an inability to attend to stimuli, including one's own body parts, people, and objects, on the most affected side of the body. This study aims to determine whether it’s feasible to use EyeFocus with stroke survivors with neglect when delivered by a therapist within-hospital settings.
Who can participate?
Stroke survivors from age 18 onwards with signs of neglect, as assessed by two standardised neglect measures, who can sit in front of a table for 30 minutes and can follow a one-stage command.
What does the study involve?
The EyeFocus intervention consists of 5 daily 30-minute sessions over 7 days within acute or community hospitals. The patient will complete the EyeFocus exercises using the tablet app provided.
What are the possible benefits and risks of participating?
Even though it is not possible to assure the patient that they will show differences in their neglect measures or symptoms, participating in the study will help obtain information on future therapies for stroke survivors. There are no known risks in participating in the protocol.
Where is the study run from?
This research is being carried out by researchers at the Neuropsychology Lab at the University of East Anglia, and two Clinical Occupational Therapists in the Norfolk and Norwich University Hospitals NHS Foundation Trust, and it is run in two different participating NHS Partner Sites in the East of England area.
When is the study starting and how long is it expected to run for?
February 2026 to July 2026.
Who is funding the study?
National Institute for Health and Care Research (NIHR), UK.
Who is the main contact?
Dr Stephanie Rossit (Principal Investigator), S.Rossit@uea.ac.uk
Contact information
Public, Scientific, Principal investigator
Lawrence Stenhouse Building, University of East Anglia, Norwich Research Park
Norwich
NR4 7TJ
United Kingdom
 ORCID ID |
0000-0001-6640-2289 |
|---|---|
| Phone | +44 01603591674 |
| s.rossit@uea.ac.uk |
Public
Lawrence Stenhouse Building, University of East Anglia, Norwich Research Park
Norwich
NR4 7TJ
United Kingdom
| Phone | +44 01603591674 |
|---|---|
| eyefocus@uea.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Treatment |
| Scientific title | Assessing the clinical feasibility of the EyeFocus app for attention rehabilitation in ABI |
| Study acronym | EyeFocus |
| Study objectives | To investigate the clinical feasibility of EyeFocus on post-stroke neglect when delivered by a therapist in tightly controlled within-hospital settings. The primary research aims are to: (1) Determine whether it’s feasible to use EyeFocus in clinical settings with stroke survivors with neglect (2) Determine whether a larger trial could be run in the future (3) Explore patients' and clinicians' perspectives on using EyeFocus; this is paramount in understanding whether the app is usable and accepted by stroke survivors and clinicians (4) Explore potential effects and effect sizes of EyeFocus compared to usual care to inform future Phase II trial. |
| Ethics approval(s) |
Approved 02/12/2025, Health and Care Research Wales (Floor Four, North Welsh Government Offices, Cathays Park, King Edward VII Avenue, Cardiff, CF10 3NQ, United Kingdom; +44 02920 230457; healthandcareresearch@wales.nhs.uk), ref: 25/WA/0319 |
| Health condition(s) or problem(s) studied | Specialty: Stroke, Primary sub-specialty: Rehabilitation; Health Category: Neurological, Stroke; Disease/Condition: Cerebrovascular diseases |
| Intervention | This is a feasibility pilot study consisting of a mixed-methods, randomised, concurrent, assessor-blind, multiple-baseline, single-case experimental design (SCED or N-of-1 trial). Randomisation will be implemented by the UEA research team before the trial starts by creating a randomised list. The team will use freely available software (randomizer.org) to randomise participants to one of the three different baseline lengths. The risk of bias in N-of-1 Trials Scale and the Single-Case Reporting guideline in Behavioural interventions were used to inform the design of this study and will be reported in a published paper to inform methodological quality in design and reporting. The three baseline lengths will differ in the number of data points that will be collected per participant (i.e., three, four, or five data points), thus meeting the SCED multiple baseline criteria. In the intervention and postintervention phases, outcome measures will be taken three times per phase as per the minimum recommendation of the SCRIBE. INITIAL SCREENING Initial screening of potentially eligible participants will include a review of patient notes to confirm: Evidence of stroke, including review of radiology reports to ensure the stroke lesion is visible on a clinical scan. Confirmation that the patient meets the remaining eligibility criteria, where information is available. Potentially eligible participants will be provided with a participant information sheet. All patients pre-screened will be recorded in the screening log. Once initial screening is complete, the following activities will be undertaken: Obtain written informed consent or consultee assent to participate. Administer the Line Bisection sub-test of the Behavioural Inattention Test (BIT). Administer the Cancellation Task of the Oxford Cognitive Screen (OCS). Patients providing consent and meeting all inclusion criteria, including the minimum definition for spatial neglect (BIT line-bisection score ≤ 7, or OCS Cancellation accuracy score < 42 and either OCS Cancellation Object score > 1 or < -1, or OCS Cancellation Space score > 3 or < -2)-will complete baseline measures and have the following data collected: Clinical and demographic data. If baseline measures are not undertaken on the same day as eligibility screening, repeat: Line Bisection sub-test of the BIT OCS Cancellation Task (CT-OCS) Endpoint Weightings Line Bisection task. Oxford Cognitive Screen (full OCS). If a full OCS was conducted as part of usual care within 1 week of Baseline (TO), this measure can be used without repeating it for the trial. NIH Stroke Scale/Score (NIHSS) extracted from the most recent clinical records. Pseudonymised clinical brain imaging reports (CT and/or MRI). Pseudonymised clinical brain imaging scans (CT and/or MRI) saved to password-protected CDs/DVDs for the UEA research team. BASELINE PHASE Every patient will complete EyeFocus in addition to treatment as usual (TAU) following varying baseline assessment durations of 3, 4, or 5 consecutive days. These repeated baseline outcome assessments will include only the neglect measures: CT-OCS and Endpoint Weightings Line Bisection task. INTERVENTION PHASE After the baseline phase, trained staff will deliver the EyeFocus intervention, consisting of five 30-minute sessions over 7 days. Treatment as usual will be recorded during this time for all trial participants. Following the final intervention session, patients will complete a semi-structured interview and a System Usability Scale. Therapists will also be invited to an interview led by the UEA research team. During the intervention phase, neglect outcome measures (CT-OCS and Endpoint Weightings Line Bisection task) will be repeated after sessions 2, 3, and 5 of EyeFocus. Fidelity checklists and photographs will be taken on the 1st and last sessions of EyeFocus. POST-INTERVENTION PHASE All participants will receive a visit from a blinded assessor to repeat the neglect outcome measures on three separate days within 7 days. Participants are expected to be in the trial for approximately 3 weeks post-randomisation (3-5 days maximum baseline phase ; 7 days intervention phase; 7 days post-intervention phase). |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 31/07/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 9 |
| Key inclusion criteria | 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. Signs of neglect on at least one of the following: 4. BIT Line Bisection score < = 7, or 5. Oxford Cognitive Screen cancellation accuracy score < 42 and either Oxford Cognitive Screen Cancellation Object score > 1 or < -1, or Oxford Cognitive Screen Cancellation Space score > 3 or < -2 6. Able to follow a one-stage command “point to an object 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 |
| Key exclusion criteria | 1. Being discharged from an in-patient hospital facility to home, or to an in-patient hospital facility that is not part of the NHS site, within the next 15 days 2. Enrolled on another interventional study targeting neglect |
| Date of first enrolment | 04/02/2026 |
| Date of final enrolment | 31/07/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Norwich
NR2 3TU
England
80 Newark Street
London
E1 2ES
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan | The final data (fully anonymised) will be made available on open data repositories (e.g. International Stroke Trials, Association of Medical Research Charities Open Research Platform, Open Science Framework). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Study website | 18/03/2026 | No | No |
Editorial Notes
25/03/2026: Date of final enrolment and completion date were changed from 28/04/2026 to 31/07/2026.
12/03/2026: Study's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
