Rehabilitating Visual Deficits Caused by Stroke
Primary Purpose
Hemianopia, Hemianopsia, Quadrantanopia
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Training in the blind field
Sponsored by
About this trial
This is an interventional treatment trial for Hemianopia focused on measuring Vision, Stroke, Visual training, Blindsight, Visual pathway
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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):
- 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
Sites / Locations
- Wellcome Centre For Integrative Neuroimaging, University of OxfordRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Training in blind field
Arm Description
All participants undergo this intervention. Internal control is comparing sighted and non-sighted parts of the field.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Change in visual quality of life
Change on the Visual Function Questionnaire 25 between baseline (0-month) and 6-month follow up.
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.
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
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.
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).
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).
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.
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.
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)
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)
Full Information
NCT ID
NCT04878861
First Posted
April 28, 2021
Last Updated
May 6, 2021
Sponsor
University of Oxford
Collaborators
University of Rochester, University of Turin, Italy, University of Texas at Austin
1. Study Identification
Unique Protocol Identification Number
NCT04878861
Brief Title
Rehabilitating Visual Deficits Caused by Stroke
Official Title
Rehabilitating Visual Deficits Caused by Stroke: Neurochemical and Neurophysiological Markers for Optimal Recovery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2020 (Actual)
Primary Completion Date
October 16, 2024 (Anticipated)
Study Completion Date
October 16, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oxford
Collaborators
University of Rochester, University of Turin, Italy, University of Texas at Austin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemianopia, Hemianopsia, Quadrantanopia, Stroke Induced Vision Loss
Keywords
Vision, Stroke, Visual training, Blindsight, Visual pathway
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Training in blind field
Arm Type
Experimental
Arm Description
All participants undergo this intervention. Internal control is comparing sighted and non-sighted parts of the field.
Intervention Type
Behavioral
Intervention Name(s)
Training in the blind field
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in motion discrimination thresholds after 6 months of training
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Maintenance of improvement in motion discrimination thresholds at 9-month follow up.
Description
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.
Time Frame
9 months
Title
Change in area improved on the Humphrey perimetry (24-2 and 10-2)
Description
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.
Time Frame
6 months
Title
Maintenance area improved on the Humphrey perimetry (24-2 and 10-2)
Description
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.
Time Frame
9 months
Title
Change in contrast detection at trained locations
Description
Change in detection of stimulus at 1%, 5%, 10%, 50% and 100% contrast baseline (0-month) and 6-month follow up.
Time Frame
6 months
Title
Maintenance contrast detection at trained locations
Description
No change in detection of stimulus at 1%, 5%, 10%, 50% and 100% contrast between the 6-month and 9-month follow up.
Time Frame
9 months
Title
Change in visual quality of life
Description
Change on the Visual Function Questionnaire 25 between baseline (0-month) and 6-month follow up.
Time Frame
6 months
Title
Maintenance of visual quality of life
Description
No change in visual quality of life as measured by the Visual Function Questionnaire 25 between 6-month and 9-month follow up.
Time Frame
9 months
Title
Change in white matter integrity
Description
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
Time Frame
6 months
Title
Maintenance of white matter integrity
Description
No change of integrity in LGN-hMT+ and LGN-V1 tracts between 6-month and 9-month follow up, assessed by diffusion-weighted imaging.
Time Frame
9 months
Title
Change in neurochemistry
Description
Change in neurochemistry in visual motion area, hMT+ between baseline (0-month) and 6-month follow up, assessed by Magnetic Resonance Spectroscopy (MRS).
Time Frame
6 months
Title
Maintenance of neurochemistry
Description
No change in neurochemistry in visual motion area, hMT+ between 6-month and 9-month follow up, assessed by Magnetic Resonance Spectroscopy (MRS).
Time Frame
9 months
Title
Change in brain activity during visual stimulation (Blood-oxygen-level-dependent imaging, or BOLD, signal change)
Description
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.
Time Frame
6 months
Title
Maintenance of brain activity during visual stimulation (BOLD signal change)
Description
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.
Time Frame
9 months
Title
Change in resting state connectivity
Description
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)
Time Frame
6 months
Title
Maintenance of resting state connectivity
Description
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)
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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):
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hannah Willis, MPsych
Phone
01865 611458
Email
hannah.willis@ndcn.ox.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Holly Bridge, PhD
Phone
01865 610482
Email
holly.bridge@ndcn.ox.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holly Bridge, PhD
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wellcome Centre For Integrative Neuroimaging, University of Oxford
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannah Willis, MPsych
Phone
01865 611458
Email
hannah.willis@ndcn.ox.ac.uk
First Name & Middle Initial & Last Name & Degree
Holly Bridge, DPhil
Phone
01865 610482
Email
holly.bridge@ndcn.ox.ac.uk
First Name & Middle Initial & Last Name & Degree
Holly Bridge, DPhil
First Name & Middle Initial & Last Name & Degree
Hannah Willis, MPsych
First Name & Middle Initial & Last Name & Degree
Kate Watkins, PhD
First Name & Middle Initial & Last Name & Degree
Krystel Huxlin, PhD
First Name & Middle Initial & Last Name & Degree
Marco Tamietto, PhD
First Name & Middle Initial & Last Name & Degree
Matthew Cavanaugh, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
We plan to share subsets of the data as appropriate.
IPD Sharing Time Frame
After conclusion of study.
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Rehabilitating Visual Deficits Caused by Stroke
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