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Clinical Trials/NCT04878861
NCT04878861
Recruiting
Not Applicable

Rehabilitating Visual Deficits Caused by Stroke: Neurochemical and Neurophysiological Markers for Optimal Recovery

University of Oxford1 site in 1 country20 target enrollmentDecember 13, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemianopia
Sponsor
University of Oxford
Enrollment
20
Locations
1
Primary Endpoint
Change in motion discrimination thresholds after 6 months of training
Status
Recruiting
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 13, 2020
End Date
October 16, 2024
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

DrHollyBridge

Professor

University of Oxford

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Maintenance of improvement in motion discrimination thresholds at 9-month follow up.(9 months)
  • Change in visual quality of life(6 months)
  • Maintenance of visual quality of life(9 months)
  • Maintenance contrast detection at trained locations(9 months)
  • Maintenance of white matter integrity(9 months)
  • Change in neurochemistry(6 months)
  • Change in area improved on the Humphrey perimetry (24-2 and 10-2)(6 months)
  • Maintenance area improved on the Humphrey perimetry (24-2 and 10-2)(9 months)
  • Change in white matter integrity(6 months)
  • Change in brain activity during visual stimulation (Blood-oxygen-level-dependent imaging, or BOLD, signal change)(6 months)
  • Change in contrast detection at trained locations(6 months)
  • Maintenance of neurochemistry(9 months)
  • Maintenance of brain activity during visual stimulation (BOLD signal change)(9 months)
  • Change in resting state connectivity(6 months)
  • Maintenance of resting state connectivity(9 months)

Study Sites (1)

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