Clinical trial NCT05660057: Testing of a New Computer Screen for Patients With Persistent Concussion Symptoms (PCS).
Official title: Evaluation of a New Computer Screen for Patients With Persisting Concussion Symptoms Including Computer Screen Intolerance.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-Concussion Symptoms
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will read a short story and watch moving images for 30 minutes or until any of their persisting concussion symptoms will arise on the standard computer monitor and the newly designed computer monitor in two visits.
Primary purpose: TREATMENT

Brief summary: This study will examine whether a newly designed monitor for computers is better tolerated by concussed patients than the standard computer monitor. The information gathered from this study will contribute to the understanding of the persisting concussion symptoms including computer screen intolerance and photosensitivity, with the aim of helping those with concussions.

Detailed description: The study will involve completing a reading task on the standard computer monitor and the newly designed computer monitor. First, participants will be asked to rate their pre-test symptoms using a SCAT-III symptom checklist. Then they will read a short story and watch moving images on one of the devices (standard computer monitor or the newly designed computer monitor) for 30 minutes or until persisting concussion symptoms of moderate severity arise. Then, they will be asked to rate their post-test clinical symptoms using a SCAT-III symptom checklist. On a second visit, 7 to 10 days later, they will do the same activity on the other device. Each visit will take 60 minutes.

The study will involve 100 patients with a history of concussion and computer screen intolerance.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of persisting concussion symptoms (1 month to 5 year since concussion)
* Must speak English
* Must provide written consent
* No alcohol/recreational drug use within 24 hours of intervention
* No other neurological, psychiatric or ocular conditions

Exclusion Criteria:

* No diagnosis of Persisting Concussion Symptoms
* Under the age of 18, over the age of 65
* Other neurological/psychiatric or ocular conditions
* Alcohol or recreational drug use within 24 hours of intervention

Primary outcomes:
measure: The investigators believe that patients will subjectively perceive the new monitor to be a more effective reading device than the standard monitor.
timeFrame: Two visits 7 to 10 days apart
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Canadian Concussion Centre- Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Charles Tator, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Carmela Tartaglia, MD
role: PRINCIPAL_INVESTIGATOR
References: