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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-07

Study Completion Date

2024-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Post-Concussion Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

New computer monitor

Intervention Type DEVICE

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

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.

Group Type SHAM_COMPARATOR

New computer monitor

Intervention Type DEVICE

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

Interventions

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New computer monitor

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No