Post-Concussion SymptomsNCT05660057
Testing of a New Computer Screen for Patients With Persistent Concussion Symptoms (PCS).
A study testing New computer monitor in people with Post-Concussion Symptoms, run by University Health Network, Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Concussion Symptoms
- What is being tested?
- New computer monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 7 Nov 2022to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Canadian Concussion Centre- Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Mozhgan Khodadadi, MA, 416-603-5800 ext. 4025, mozhgan.khodadadi@uhn.ca
Charles Tator, MD,PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Post-Concussion Symptoms
- Being tested
- New computer monitor
- Medical subject headings
- Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New computer monitorDevice
The device to be studied is a newly designed computer monitor and will be compared with the standard computer monitor.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: New computer monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two visits 7 to 10 days apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start7 Nov 2022
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Concussion SymptomsStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Tator, MD, PhD, Principal investigator, University Health Network, TorontoCarmela Tartaglia, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660057
- Sponsor's protocol ID
- 22-5525
- Status last verified
- Mar 2023
- First submitted
- 2 Dec 2022
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Computer Screen for Patients With Persisting Concussion Symptoms Including Computer Screen Intolerance.
- ClinicalTrials.gov ID
- NCT05660057
- Acronym / sponsor ID
- 22-5525
- Conditions
- Post-Concussion Symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Newly designed computer monitor | Experimental | Device: New computer monitorParticipants 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. |
| Standard computer monitor | Sham comparator | Device: New computer monitorSame 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New computer monitorThe device to be studied is a newly designed computer monitor and will be compared with the standard computer monitor. | Device | Newly designed computer monitor, Standard computer monitor |
Primary outcome
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Post-Concussion Symptoms
Not yet recruiting
Electroencephalography Markers of Brain Stimulation in Post-Concussion Patients
Patients With Persistent Post-concussion Symptoms
Not yet recruitingObservational study
Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
Traumatic Brain Injury, Post-Concussion Syndrome
Recruiting
Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Post-Concussion Syndrome, COVID Long-Haul
Recruiting
Control Network Neuromodulation to Enhance Cognitive Training in Complex Traumatic Brain Injury
Traumatic Brain Injury
Active, not recruiting
Move&Connect: A Program for Youth With Concussion and Their Caregivers.
Post-Concussion Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Tator, MD, PhD principal investigator
University Health Network, Toronto
Carmela Tartaglia, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New computer monitor in people with Post-Concussion Symptoms, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mozhgan Khodadadi, MA (416-603-5800 ext. 4025, mozhgan.khodadadi@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.