Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT05660057

Conditions

Post-Concussion Symptoms

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

New computer monitor

Study Details

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.

Conditions

Post-Concussion Symptoms

Study ID

NCT05660057

Start date

Nov 7, 2022

Status verified date

Mar, 2023

Completion date

Jul, 2024

Anticipated

Primary completion date

Jul, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Newly designed computer monitor

Participants will read a short story and then watch moving images for 30 minutes or until any of their persisting concussion symptoms arise. The number and severity of symptoms will be assessed by completing SCAT -III pre- and post-study tasks.

sham comparator: Standard computer monitor

Same participants will read a short story and watch moving images for 30 minutes or until any of their persisting concussion symptoms arise on the standard computer screen.The number and severity of symptoms will be assessed by completing SCAT -III pre- and post-study tasks.

Interventions

New computer monitor

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

Primary outcome measure

  • The investigators believe that patients will subjectively perceive the new monitor to be a more effective reading device than the standard monitor. [ Time Frame: Two visits 7 to 10 days apart ]

Central Contacts and Locations

Central contacts

Locations

Canadian Concussion Centre- Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Principal Investigator:

Charles Tator, MD,PhD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 31, 2023

Last verified

Mar, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2023-03-31.