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

NCT05660057 | Unknown

• 1 other identifier: 22-5525
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Newly designed computer monitor

EXPERIMENTAL

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

Standard computer monitor

SHAM COMPARATOR

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

Interventions

New computer monitor DEVICE

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

Newly designed computer monitor; Standard computer monitor

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Canadian Concussion Centre- Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Post-Concussion Syndrome

Condition Hierarchy (Ancestors)

Brain Concussion; Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Charles Tator, MD, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Carmela Tartaglia, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mozhgan Khodadadi, MA

CONTACT

416-603-5800; mozhgan.khodadadi@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 21, 2022
• Study Start: November 7, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)