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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Post-Concussion Symptoms
• Intervention / Treatment: Device: New computer monitor

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Recruiting
      • Canadian Concussion Centre- Toronto Western Hospital
      • Principal Investigator: Carmela Tartaglia, MD
      • Principal Investigator: Charles Tator, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: New computer monitor; The device to be studied is a newly designed computer monitor and will be compared with the standard computer monitor.
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.	Device: New computer monitor; The device to be studied is a newly designed computer monitor and will be compared with the standard computer monitor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Charles Tator, MD, PhD, University Health Network, Toronto; Principal Investigator: Carmela Tartaglia, MD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2022
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: December 2, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Concussion; Head Injuries, Closed; Wounds, Nonpenetrating; Post-Concussion Syndrome
• Other Study ID Numbers: 22-5525

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No