Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06241209 |
| Other study ID # |
00134526 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 25, 2024 |
| Est. completion date |
December 15, 2028 |
Study information
| Verified date |
January 2024 |
| Source |
University of Alberta |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
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.
