HemianopiaNCT04878861
Rehabilitating Visual Deficits Caused by Stroke
A study testing Training in the blind field in people with Hemianopia and Hemianopsia, run by University of Oxford at 1 site in United Kingdom.
Trial summary
This research aims to understand the efficacy of a visual training task to improve visual loss after stroke, also known as hemianopia. The investigators aim to understand whether training can improve vision and which areas or pathways in the brain are responsible for this improvement. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemianopia, Hemianopsia, Quadrantanopia
- What is being tested?
- Training in the blind field
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Dec 2020to 16 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-80
- Participant is willing and able to give informed consent for participation in the study
- Fluent English-speaking healthy adults
- Has suffered damage to the visual cortex at least 6 months before the study
Who cannot join
- Previous eye disease or impairment other than hemianopia
- Neurological or psychiatric illness
- Contraindication to MRI
- Pregnant or breast feeding
- Second stroke during training
- Data quality assurance (participant data will be removed from analysis for the following reasons):
Show all 10Show fewer
- Concurrent participation in other "vision therapy"
- Unreliable visual fields, indicated by greater than 20% fixation losses, false positives, or false negatives
- Inability to demonstrate fixation stability on eye movement monitored testing
- Failure to complete at least 100 training sessions over 6-months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Wellcome Centre For Integrative Neuroimaging, University of Oxford
Oxford, Oxfordshire, OX3 9DU
Hannah Willis, MPsych, 01865 611458, hannah.willis@ndcn.ox.ac.uk
Holly Bridge, DPhil, 01865 610482, holly.bridge@ndcn.ox.ac.uk
About this study
Official title: Rehabilitating Visual Deficits Caused by Stroke: Neurochemical and Neurophysiological Markers for Optimal Recovery
This research aims to understand the efficacy of a visual training task to improve visual loss after stroke, also known as hemianopia. The investigators aim to understand whether training can improve vision and which areas or pathways in the brain are responsible for this improvement.
Read the detailed description
Damage to the primary visual cortex (V1) due to stroke usually results in loss of visual function in half of the visual world, this is known as hemianopia. This visual loss can negatively affect quality of life, as most stroke survivors are no longer permitted to drive and have difficulties with navigation and socialising. There are currently limited treatment options, although recent evidence suggests that visual training can be effective in improving visual function (Huxlin et al, 2009; Cavanaugh \& Huxlin, 2017). The aim of this research is to determine the capacity for visual rehabilitation after stroke using visual training and to understand the underlying brain mechanisms that might drive these improvements. This study will help the investigators to understand the brain mechanisms involved in visual rehabilitation and may allow the investigators to predict those most likely to benefit from visual rehabilitation in the future.
Twenty stroke survivors with hemi- or quadrantanopia will complete a 6-month visual motion discrimination training programme at home. Each participant will have three study visits; at baseline, 6-months and 9-months. At each visit the investigators will take measures of 1) visual fields 2) detailed tests of visual function 3) quality of life and 4) MRI scans of brain structure, function and neurochemistry. Between the baseline (0 month) and 6-month post-training session, participants will complete visual training at home. Between the 6-month post-training session and 9-month follow up, participants will not complete visual training at home. This study will therefore allow the investigators to determine whether rehabilitation improves conscious visual perception and quality of life as well as providing understanding of the neural mechanisms that underlie this improvement. The investigators will also determine whether improvements or neural changes persist after 3-months without training.
- Conditions
- Hemianopia, Hemianopsia, Quadrantanopia, Stroke Induced Vision Loss
- Being tested
- Training in the blind field
- Keywords
- Vision, Stroke, Visual training, Blindsight, Visual pathway
- Medical subject headings
- Hemianopsia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training in the blind fieldBehavioural
Participants will complete visual training at two locations in the blind field. These two locations of training will be determined at the baseline study visit (0 months) and will be located within the perimetry-defined blind field. The training programme involves discriminating the direction of motion in a small circle of moving dots. The computer software and a chin-rest will be loaned to each participant to complete training at home. Participants will perform 300 trials at each location in their blind field, 5 days a week for at least 24 weeks (40-60 minutes in total). The computer programme will automatically generate a record of participant performance after each home training session.
| Study group | Role | What they receive |
|---|---|---|
| Training in blind field | Experimental | All participants undergo this intervention. Internal control is comparing sighted and non-sighted parts of the field. Receives: Behavioral: Training in the blind field |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in motion discrimination thresholds after 6 months of training
Change in normalised discrimination thresholds on psychophysical motion discrimination task at two trained locations between baseline (0-month) and 6-month follow up. These assessments will be based on what motion can be reliably detected at a 75% correct level of performance.
Measured: 6 months
Secondary outcomes (15)
Maintenance of improvement in motion discrimination thresholds at 9-month follow up.
No change in normalised discrimination thresholds on psychophysical motion discrimination task at two trained locations between 6-month and 9-month follow up. These assessments will be based on what motion can be reliably detected at a 75% correct level of performance.
Measured: 9 months
Change in area improved on the Humphrey perimetry (24-2 and 10-2)
Change in area improved on a composite measure of deficit size calculated from 24-2 and 10-2 across both eyes. Area of improvement will be calculated as the area where the sensitivity improved by more than 6 decibels (dB) relative to pre-training.
Measured: 6 months
Maintenance area improved on the Humphrey perimetry (24-2 and 10-2)
No change in area improved on a composite measure of deficit size calculated from 24-2 and 10-2 across both eyes. Area of improvement will be calculated as the area where the sensitivity improved by more than 6dB relative to pre-training.
Measured: 9 months
Change in contrast detection at trained locations
Change in detection of stimulus at 1%, 5%, 10%, 50% and 100% contrast baseline (0-month) and 6-month follow up.
Measured: 6 months
Maintenance contrast detection at trained locations
No change in detection of stimulus at 1%, 5%, 10%, 50% and 100% contrast between the 6-month and 9-month follow up.
Measured: 9 months
Change in visual quality of life
Change on the Visual Function Questionnaire 25 between baseline (0-month) and 6-month follow up.
Measured: 6 months
Maintenance of visual quality of life
No change in visual quality of life as measured by the Visual Function Questionnaire 25 between 6-month and 9-month follow up.
Measured: 9 months
Change in white matter integrity
Change in white matter integrity in lateral geniculate nucleus (LGN) to extrastriate motion area (hMT+) and LGN to primary visual cortex (V1) tracts between baseline (0-month) and 6-month follow up, assessed by diffusion-weighted imaging
Measured: 6 months
Maintenance of white matter integrity
No change of integrity in LGN-hMT+ and LGN-V1 tracts between 6-month and 9-month follow up, assessed by diffusion-weighted imaging.
Measured: 9 months
Change in neurochemistry
Change in neurochemistry in visual motion area, hMT+ between baseline (0-month) and 6-month follow up, assessed by Magnetic Resonance Spectroscopy (MRS).
Measured: 6 months
Maintenance of neurochemistry
No change in neurochemistry in visual motion area, hMT+ between 6-month and 9-month follow up, assessed by Magnetic Resonance Spectroscopy (MRS).
Measured: 9 months
Change in brain activity during visual stimulation (Blood-oxygen-level-dependent imaging, or BOLD, signal change)
Change in brain activity during moving visual stimulation, assessed by functional magnetic resonance imaging (BOLD signal) in visual motion area, hMT+ between baseline (0 month) and 6-month follow up.
Measured: 6 months
Maintenance of brain activity during visual stimulation (BOLD signal change)
Maintenance of brain activity during moving visual stimulation, assessed by functional magnetic resonance imaging (BOLD signal) in visual motion area, hMT+ between the 6-month and 9-month follow up.
Measured: 9 months
Change in resting state connectivity
Change in resting state connectivity in the visual cortex between baseline (0-months) and 6-months, assessed by resting state functional magnetic resonance imaging (BOLD signal)
Measured: 6 months
Maintenance of resting state connectivity
Maintenance of resting state connectivity in the visual cortex between 6-month and 9-month follow up, assessed by resting state functional magnetic resonance imaging (BOLD signal)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start13 Dec 2020
- Primary completion16 Oct 2024 (estimated)
- Study completion16 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemianopiaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rochester, University of Turin, Italy, University of Texas at Austin
- Responsible party
- Principal investigator, DrHollyBridge, University of Oxford
- Investigators
- Holly Bridge, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878861
- Sponsor's protocol ID
- R60132/RE001
- Status last verified
- May 2021
- First submitted
- 28 Apr 2021
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share subsets of the data as appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitating Visual Deficits Caused by Stroke: Neurochemical and Neurophysiological Markers for Optimal Recovery
- ClinicalTrials.gov ID
- NCT04878861
- Acronym / sponsor ID
- R60132/RE001
- Conditions
- Hemianopia, Hemianopsia, Quadrantanopia, Stroke Induced Vision Loss
- Keywords
- Vision, Stroke, Visual training, Blindsight, Visual pathway
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- University of Rochester, University of Turin, Italy, University of Texas at Austin
- Study start
- 13 Dec 2020 (actual)
- Primary completion
- 16 Oct 2024 (estimated)
- Study completion
- 16 Oct 2024 (estimated)
- First posted
- 10 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research aims to understand the efficacy of a visual training task to improve visual loss after stroke, also known as hemianopia. The investigators aim to understand whether training can improve vision and which areas or pathways in the brain are responsible for this improvement.
Detailed description
Damage to the primary visual cortex (V1) due to stroke usually results in loss of visual function in half of the visual world, this is known as hemianopia. This visual loss can negatively affect quality of life, as most stroke survivors are no longer permitted to drive and have difficulties with navigation and socialising. There are currently limited treatment options, although recent evidence suggests that visual training can be effective in improving visual function (Huxlin et al, 2009; Cavanaugh \& Huxlin, 2017). The aim of this research is to determine the capacity for visual rehabilitation after stroke using visual training and to understand the underlying brain mechanisms that might drive these improvements. This study will help the investigators to understand the brain mechanisms involved in visual rehabilitation and may allow the investigators to predict those most likely to benefit from visual rehabilitation in the future.
Twenty stroke survivors with hemi- or quadrantanopia will complete a 6-month visual motion discrimination training programme at home. Each participant will have three study visits; at baseline, 6-months and 9-months. At each visit the investigators will take measures of 1) visual fields 2) detailed tests of visual function 3) quality of life and 4) MRI scans of brain structure, function and neurochemistry. Between the baseline (0 month) and 6-month post-training session, participants will complete visual training at home. Between the 6-month post-training session and 9-month follow up, participants will not complete visual training at home. This study will therefore allow the investigators to determine whether rehabilitation improves conscious visual perception and quality of life as well as providing understanding of the neural mechanisms that underlie this improvement. The investigators will also determine whether improvements or neural changes persist after 3-months without training.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training in blind field | Experimental | Behavioral: Training in the blind fieldAll participants undergo this intervention. Internal control is comparing sighted and non-sighted parts of the field. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-80
- Participant is willing and able to give informed consent for participation in the study
- Fluent English-speaking healthy adults
- Has suffered damage to the visual cortex at least 6 months before the study
Key exclusion criteria (10 listed)
- Previous eye disease or impairment other than hemianopia
- Neurological or psychiatric illness
- Contraindication to MRI
- Pregnant or breast feeding
- Second stroke during training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training in the blind fieldParticipants will complete visual training at two locations in the blind field. These two locations of training will be determined at the baseline study visit (0 months) and will be located within the perimetry-defined blind field. The training programme involves discriminating the direction of motion in a small circle of moving dots. The computer software and a chin-rest will be loaned to each participant to complete training at home. Participants will perform 300 trials at each location in their blind field, 5 days a week for at least 24 weeks (40-60 minutes in total). The computer programme will automatically generate a record of participant performance after each home training session. | Behavioural | Training in blind field |
Primary outcome
Change in motion discrimination thresholds after 6 months of training
Time frame: 6 months
Change in normalised discrimination thresholds on psychophysical motion discrimination task at two trained locations between baseline (0-month) and 6-month follow up. These assessments will be based on what motion can be reliably detected at a 75% correct level of performance.
15 secondary outcomes
Maintenance of improvement in motion discrimination thresholds at 9-month follow up.
Time frame: 9 months
Change in area improved on the Humphrey perimetry (24-2 and 10-2)
Time frame: 6 months
Maintenance area improved on the Humphrey perimetry (24-2 and 10-2)
Time frame: 9 months
Change in contrast detection at trained locations
Time frame: 6 months
Maintenance contrast detection at trained locations
Time frame: 9 months
Change in visual quality of life
Time frame: 6 months
Maintenance of visual quality of life
Time frame: 9 months
Change in white matter integrity
Time frame: 6 months
Maintenance of white matter integrity
Time frame: 9 months
Change in neurochemistry
Time frame: 6 months
Maintenance of neurochemistry
Time frame: 9 months
Change in brain activity during visual stimulation (Blood-oxygen-level-dependent imaging, or BOLD, signal change)
Time frame: 6 months
Maintenance of brain activity during visual stimulation (BOLD signal change)
Time frame: 9 months
Change in resting state connectivity
Time frame: 6 months
Maintenance of resting state connectivity
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Individual participant dataSharing planned: Yes. We plan to share subsets of the data as appropriate.
Related trials for Hemianopia
Not yet recruiting
Ameliorating Stroke-induced Hemianopia Via Multisensory Training
Hemianopia, Homonymous, Cortical Blindness, Unspecified Side of Brain
Active, not recruiting
Statistical Learning as a Novel Intervention for Cortical Blindness
Stroke, Ischemic, Hemianopia, Homonymous
Not yet recruitingObservational study
Anatomical and Functional Predictions of Blindsight Capabilities in Patients With Lateral Hemianopsia
Homonymous Hemianopia, Stroke
Not yet recruiting
Effects of Optokinetic Stimulation Without a Reading Task in Patients With Hemianopic Alexia
Hemianopia Homonymous, Stroke
Not yet recruiting
Effectiveness of a Visual Telerehabilitation Program on Visual Perception in Children, Adolescents and Young Adults With Hemianopsia Consecutive to a Brain Tumour
Hemianopsia, Virtual Reality
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holly Bridge, PhD principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in the blind field in people with Hemianopia and Hemianopsia, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hannah Willis, MPsych (01865 611458, hannah.willis@ndcn.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in motion discrimination thresholds after 6 months of training (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.