Hemianopsia Rehabilitation After Stroke or Brain Injury

January 26, 2024 updated by: University of Alberta
In patients with hemianopsia following stroke or brain injury, we will determine if stimulating the visual field with images from a PowerPoint slide set can increase the visual field.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Purpose: To determine if a computer screen visual stimulation can improve peripheral field loss in patients with vision pathway brain injury.

Hypothesis: Visual stimulation helps patients with visual pathway brain injury recover peripheral vision.

Justification: i) Axonal sprouting or re-rerouting can occur after brain injury ii) In Canada stroke prevalence comprises almost 900,000 patients. (Canada.ca, Health 2022). It is estimated that half of stroke survivors have a visual field deficit. (Rowe et al, PLoS One. 2019).

There is clinical equipoise regarding the results of vision therapy with visual stimulation. Romano JG, et al. Journal of the Neurological Sciences. 2008 Oct 15;273(1-2):70-4. versus Horton JC. Disappointing results from Nova Vision's visual restoration therapy. British Journal of Ophthalmology. 2005

Objectives: To determine the effect size of visual recovery, if any with computer screen visual stimulation

Research Method/Procedures

The project is prospective. Patients undergoing visual field testing found to have a hemianopsia will be invited to participate in the study. Chart review will be conducted on Connect Care. The following information will be collected: Patient age, sex, hand dominance, location and extent of stroke, number of prior strokes, time since initial/last stroke, neurologic diagnosis of neglect, perimetric findings, hours of television viewing, hours of smart phone use, hours of playing video games, smoking history, hypertension, diabetes mellitus, and hyperlipidemia.

Group 1 with an odd number year of birth will be asked to view 15 minutes of online news three days per week for 2 months. LIVE: Canadian News | Weather & Traffic - Latest Sports | Breaking News (globalnews.ca)

Group 2 with an even number year of birth will be asked to view the 15-minute PowerPoint program three days per week for 2 months.

At the end of 2 months, the study groups will be asked to cross over for 2 months, and perimetry will be repeated at month 4 from study entry. If patients originally in Group 2 do not want to stop using the PowerPoint program, they will be allowed to drop out of the study.

A 24-degree Humphrey automated perimetry will be performed at study entry, month two and month four. The perimeter provides a visual field index (VFI) with scores ranging from zero (no perceived light) to 100 (normal).

PLAN FOR DATA ANALYSIS: For each patient, the VFI from both eyes will be averaged. The difference between the pre-intervention and post-intervention VFI's will be compared between the PowerPoint intervention versus observation groups after 2 months. The same analysis will be repeated after the cross-over.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5J 0N3
        • Recruiting
        • Eye Institute of Alberta, Royal Alexandra Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Edsel Ing, MD PhD
        • Sub-Investigator:
          • Imran Jivraj, MD
        • Sub-Investigator:
          • Galvez Ruiz Alberto, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

All patients 18 years of age or older with a homonymous hemianopsia or quadrantopsia, who can provide informed consent, and communicate in English.

Exclusion Criteria:

  • The flashing lights from thge automated perimeter and PowerPoint program can potentially trigger photic seizures. Therefore patients with light-induced seizures are excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group 1 (online news)
Group 1 with an odd number year of birth will be asked to view 15 minutes of online news three days per week for 2 months. LIVE: Canadian News | Weather & Traffic - Latest Sports | Breaking News (globalnews.ca)
Active Comparator: Group 2 (PowerPoint program)
Group 2 with an even number year of birth will be asked to view the 15-minute PowerPoint program three days per week for 2 months.
Other: PowerPoint program visual stimulation
Moving objects, food, money, and other targets will be presented in the remaining seeing, and hemianopic areas.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Field Index on Humphrey perimetry
Time Frame: 2 months
(100 is an intact field)
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2024

Primary Completion (Estimated)

December 15, 2027

Study Completion (Estimated)

December 15, 2028

Study Registration Dates

First Submitted

December 8, 2023

First Submitted That Met QC Criteria

January 26, 2024

First Posted (Estimated)

February 5, 2024

Study Record Updates

Last Update Posted (Estimated)

February 5, 2024

Last Update Submitted That Met QC Criteria

January 26, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00134526

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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