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

Primary Purpose

Post-Concussion Symptoms

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
New computer monitor
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Concussion Symptoms

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Canadian Concussion Centre- Toronto Western HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Newly designed computer monitor

Standard computer monitor

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 2, 2022
Last Updated
March 29, 2023
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT05660057
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Concussion Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Newly designed computer monitor
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard computer monitor
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
New computer monitor
Intervention Description
The device to be studied is a newly designed computer monitor and will be compared with the standard computer monitor.
Primary Outcome Measure Information:
Title
The investigators believe that patients will subjectively perceive the new monitor to be a more effective reading device than the standard monitor.
Description
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.
Time Frame
Two visits 7 to 10 days apart

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mozhgan Khodadadi, MA
Phone
416-603-5800
Ext
4025
Email
mozhgan.khodadadi@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Tator, MD, PhD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carmela Tartaglia, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Canadian Concussion Centre- Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mozhgan Khodadadi, MA
Phone
416-603-5800
Ext
4025
Email
mozhgan.khodadadi@uhn.ca
First Name & Middle Initial & Last Name & Degree
Charles Tator, MD,PhD
First Name & Middle Initial & Last Name & Degree
Carmela Tartaglia, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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