Hemianopsia Rehabilitation After Stroke or Brain Injury

NCT ID: NCT06241209

Last Updated: 2025-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-25

Study Completion Date

2028-12-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hemianopsia Visual Field Defect, Peripheral Visual Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

PowerPoint program visual stimulation

Intervention Type OTHER

Moving objects, food, money, and other targets will be presented in the remaining seeing, and hemianopic areas.

Interventions

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PowerPoint program visual stimulation

Moving objects, food, money, and other targets will be presented in the remaining seeing, and hemianopic areas.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Eye Institute of Alberta, Royal Alexandra Hospital

Edmonton, Alberta, Canada

Site Status RECRUITING

Countries

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Canada

Facility Contacts

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Edsel Ing, MD PhD MPH

Role: primary

16472930155

Rita Whitford

Role: backup

Related Links

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Other Identifiers

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00134526

Identifier Type: -

Identifier Source: org_study_id

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