Rehabilitating Visual Deficits Caused by Stroke

NCT04878861 | Unknown

• 1 other identifier: R60132/RE001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemianopia; Hemianopsia; Quadrantanopia; Stroke Induced Vision Loss

Keywords

Vision; Stroke; Visual training; Blindsight; Visual pathway

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (15)

• Maintenance of improvement in motion discrimination thresholds at 9-month follow up.

  9 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 contrast detection at trained locations

  6 months

• Maintenance contrast detection at trained locations

  9 months

Study Arms (1)

Training in blind field

EXPERIMENTAL

All participants undergo this intervention. Internal control is comparing sighted and non-sighted parts of the field.

Behavioral: Training in the blind field

Interventions

Training in the blind field BEHAVIORAL

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.

Training in blind field

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead
• University of Rochester: collaborator
• University of Turin, Italy: collaborator
• University of Texas at Austin: collaborator

Study Sites (1)

Wellcome Centre For Integrative Neuroimaging, University of Oxford

Oxford, Oxfordshire, OX3 9DU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hemianopsia; Stroke

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Blindness; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Holly Bridge, PhD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah Willis, MPsych

CONTACT

01865 611458; hannah.willis@ndcn.ox.ac.uk

Holly Bridge, PhD

CONTACT

01865 610482; holly.bridge@ndcn.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 10, 2021
• Study Start: December 13, 2020
• Primary Completion: October 16, 2024
• Study Completion: October 16, 2024
• Last Updated: May 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: After conclusion of study.

Locations

GB (1)