Testing of a New Computer Screen for Patients With Persistent Concussion Symptoms (PCS).

Post-Concussion Symptoms Clinical Trial

Official title:

Evaluation of a New Computer Screen for Patients With Persisting Concussion Symptoms Including Computer Screen Intolerance.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05660057
• Other study ID #: 22-5525
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2022
• Est. completion date: July 2024

Study information

• Verified date: March 2023
• Source: University Health Network, Toronto
• Contact: Mozhgan Khodadadi, MA
• Phone: 416-603-5800
• Email: mozhgan.khodadadi[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Post-Concussion Symptoms
• Post-Concussion Syndrome

Intervention

Device:
• New computer monitor
The device to be studied is a newly designed computer monitor and will be compared with the standard computer monitor.

Locations

Country	Name	City	State
Canada	Canadian Concussion Centre- Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The investigators believe that patients will subjectively perceive the new monitor to be a more effective reading device than the standard monitor.	SCAT-III Symptoms checklist will be completed before and after study tasks (reading an excerpt and watching a moving image) to measure symptoms number and severity arising after the study task on a standard monitor and compare it to the newly designed monitor.	Two visits 7 to 10 days apart