Eye movement training in visual field defect patients by using a 3D game
| ISRCTN | ISRCTN69117496 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69117496 |
| IRAS number | 321304 |
| Secondary identifying numbers | IRAS 321304 |
- Submission date
- 04/11/2022
- Registration date
- 14/11/2022
- Last edited
- 21/05/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Hemianopia or homonymous hemianopia (HH) is a visual field defect causing partial or complete blindness in one side (left or right) of the visual field. A common cause of hemianopia is cerebral infarction (stroke). A significant population of stroke patients, estimated at between 20% and 57%, are affected by this condition. 8% to 10% of stroke patients have permanent hemianopia.
Visual field defects affect the quality of life and functional ability in daily activities such as driving, mobility and reading. In addition, visual field defects may cause anxiety, depression and social isolation which affects the ability to participate in conventional rehabilitation programmes.
The study is designed to present visual stimulus sequences that replicate a conventional visual search scanning with additional audio cues to simulate real-life environments and turn the task into a ‘game’ where patients are awarded performance-related points.
Who can participate?
Participants who meet the eligibility criteria, particularly, MRI safety and residual homonymous hemianopia following stroke, partially or completely.
What does the study involve?
The participant will complete the 30 min VR training for 6 weeks, 5 days weekly, 30 sessions in their home, while other behavioural tasks and MRI scan will take place in our medical imaging centre which include; Digital VISION, Bell task, interview and MRI scan.
What are the possible benefits and risks of participating?
Participants may notice improvement in the daily life activities after the training. The commercial VR system is enjoyable for most people with no risks. Some people may, however, find the VR headset uncomfortable or may experience a headache or eyestrain after long term use (Simulator sickness). Participants will be instructed to train for 30 mins per day and given the opportunity to take breaks as required. Participants will be scanned in a 3 Tesla magnet; there is therefore a potential risk of injury to participants and researchers because of the strong magnetic field in the scanner room. The initial assessment will be conducted by the MRI radiologist at LiMRIC, who will ensure MRI compatibility for all participants. There is also the risk of missile hazards from objects being bought into the scanner room that are magnetic. A further risk comes from the audible noise of the scanner. The psychologically adverse risk of note is that participants may become uncomfortable or claustrophobic in the scanner.
Where is the study run from?
University of Liverpool (UK)
When is the study starting and how long is it expected to run for?
September 2021 to April 2026
Who is funding the study?
King Saud bin Abdulaziz University for Health Sciences (Saudi Arabia)
Who is the main contact?
Dr Georg Meyer, georg@liverpool.ac.uk
Contact information
Principal Investigator
Virtual Engineering Centre
University of Liverpool
Liverpool
L69 3RF
United Kingdom
| Phone | +44 1517946300 |
|---|---|
| Georg@liverpool.ac.uk |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Home, Internet/virtual, University/medical school/dental school |
| Study type | Other |
| Participant information sheet | 42715 PIS v1 01Apr2022.pdf |
| Scientific title | Examination of brain plasticity through structural and functional MRI during the audio-visual training in hemianopia patients with virtual reality (VR) |
| Study objectives | The objective of the proposed research is to test whether VR rehabilitation for hemianopia leads to measurable subjective and objective behavioural performance measures and to test whether these changes are linked to functional and structural brain imaging metrics. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Hemianopia (partial or complete) |
| Intervention | The study is designed to present visual stimulus sequences that replicate a conventional visual search scanning with additional audio cues to simulate real-life environments and turn the task into a ‘game’ where patients are awarded performance-related points. The proposed study closely follows recent work at the University of Liverpool that demonstrated the outcomes listed above in a healthy population (Aloufi, Rowe & Meyer, 2021). We will report functional and structural brain changes by using fMRI, DTI and structural imaging sequences. Data analysis will follow a previously developed and validated analysis pathway optimised using healthy controls. Three main measurements will be reported: behavioural, functional and structural measurements, before and after the training period. Details are given below that it has been also used in Aloufi, Rowe and Meyer (2021), with additional behavioural tests. The study participants will take part in MRI scanning, training and behavioural tasks: 1. VR training in the participant’s home for 30-minute daily sessions, 5 days a week and for 6 consecutive weeks, the participants will perform the VR audio-visual training. 2. Behavioural tests will be conducted in our imaging centre (LiMRIC), before (week 0) and after the training (week 7) which include: 2.1. Digital VISION visual searching training: Participants will be asked to perform standardised tests in a lab environment that enables us to measure eye gaze to establish changes in fixation patterns with training. 2.2. Bell task: Behavioural performance on a visual search task (Bells task - Basagni et al., 2017) will be collected before and after the intervention. Participants will be asked to find printed objects on a monochrome printed (A0 size) poster to provide a wide-field assessment. 2.3. QFV-25 questionnaire interview: The National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) was designed to measure the quality of life for people who have a chronic eye disease (Mangione, 2001). The NEI VFQ-25 questionnaire consists of 25 vision-targeted questions which include 11 vision-related constructs, and one general health rating question. These 25 questions are divided into two categories; 16 rate difficulty with activities and 9 ask for level of agreement to describe the severity of problems associated with visual loss. 3. MRI scanning: We will scan participants at two points of their training programme using sequences that are widely used: functional imaging, DTI and structural (T1 and T2 weighted) imaging, functional MRI (fMRI). |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Mean response time and number of correct targets measured using a VR headset during the 30-minute daily sessions, 5 days a week and for 6 consecutive weeks 2. Mean response time and number of correct targets measured in the Digital VISION search at baseline and post training |
| Secondary outcome measures | 1. Mean response time will be measured in Bell task at baseline and post training. 2. Brain activity and connectivity will be observed using MRI scanning at baseline and post training. |
| Overall study start date | 20/09/2021 |
| Completion date | 30/04/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Participants are required to be residual homonymous hemianopia (partial or complete following stroke. 2. Participants must have normal hearing and no speaking/communication difficulty. 3. Participants must speak English fluently - in order to understand all training and test instructions. 4. Participants must be 18 or older. 5. Participants must be able to perform the behavioural tasks, for which training will be provided. 6. Participants must be sufficiently mobile to attend scanning at the imaging centre/LiMRIC |
| Key exclusion criteria | 1. Participant who cannot sign the consent form or cannot read the participants’ information sheet and consent form. 2. Participants who cannot perform the task (the screening takes place before participants are invited to join the study to ensure that, participants can perform the task and to exclude vulnerable adults). 3. MR exclusion criteria: Standard MR exclusion criteria will apply (e.g. claustrophobia (fear of tight spaces), cardiac pacemaker, metal in the eye, vascular clips, actual or possible pregnancy). 4. COVID-19 check: if the participant has any symptoms before the first visit to LiMRIC for the MRI scan and before the training starts (Cough, fever, loss or change in the smell or taste https://www.nhs.uk/conditions/coronavirus-covid-19/symptoms/#symptoms), there is a flexibility to delay the starting of study, but this delaying can not be offer after the study is started. they will be excluded. We will be followed the COVID-19 procedure for LiMRIC at the recruitment period. |
| Date of first enrolment | 29/04/2024 |
| Date of final enrolment | 28/02/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Liverpool
L9 7AL
United Kingdom
Sponsor information
University/education
Clinical Directorate
4th Floor Thompson Yates Building
Faculty of Health and Life Sciences
Liverpool
L69 3GB
England
United Kingdom
| Phone | +44 7717 863747 |
|---|---|
| sponsor@liverpool.ac.uk | |
| Website | http://www.liv.ac.uk/ |
"ROR" |
https://ror.org/04xs57h96 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- جامعة الملك سعود بن عبد العزيز للعلوم الصحية, King Saud bin Abdulaziz University for Health Sciences, KSAU-HS
- Location
- Saudi Arabia
Results and Publications
| Intention to publish date | 30/04/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | This is a PhD project in which participant data will not be shared outside the university of Liverpool. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1 | 01/04/2022 | 14/11/2022 | No | Yes |
Additional files
Editorial Notes
21/05/2024: The recruitment start date was changed from 01/03/2023 to 29/04/2024.
14/02/2023: The study setting has been changed from ‘Other’.
14/11/2022: Trial's existence confirmed by Royal Embassy of Saudi Arabia.
