Research Ethics Board Institution:
University of Prince Edward Island Research Ethics Board Protocol: #6007758
Health PEI Ethics Board Protocol: Development of Objective Measures of Concussion Status and Severity
Study Procedure and Testing Process:
1.Contralateral Auditory Suppression of Transient Evoked Otoacoustic Emissions (CASTEOAE) technology will be used to measure impairments in hearing function that can arise due to a concussion. You will be asked to wear head phones and listen to different sounds. Researchers will measure the dampening of sounds produced from the inner ear and will compare the values to a healthy population. This technique is currently being investigated as part of a Master’s student project. You will be asked to participate in this test at three time points (day 1, day 7 and day 14).
2.Digital Enzyme-Linked Immunosorbent Assay (dELISA) technology, by Quanterix Corporation, will be used to measure specific markers in your blood that have been shown to increase as a result of a concussion, and that may shed light on whether a person has had a concussion, how bad it is and what their potential for recover is. You will be asked to give two 6 ml samples of blood at three time points (day 1, day 7 and day 14). Two examples of biological markers that we will measure in the blood are called Glial Fibrillary Acid Protein (GFAP) and Ubiquitn Carboxyl Hydrolase L1 (UCH-L1), both of which have been approved as indicators of concussion by the FDA.
3. The Corsi Block Tapping Test will be used to measure pattern recollection and memory. The Corsi Block Tapping Test will be administered using a mobile tablet. The blocks will light up in a particular order and you will be asked to copy that pattern. The number of blocks added to the pattern increases as the individual progresses through the levels. You will be asked to participate in this test at three time points (day 1, day 7 and day 14).
What is the time commitment?
Participation in this study will involve three sessions. Session 1 (day 1) will involve intake and testing, and will take ~60 min. Session 2 (day 7) will involve testing only and will take ~35 min and Session 3 (day 14) will involve testing only and will take ~35 min.
Am I eligible?
You are eligible to participate in this study if you:
- You are a male or female aged 16-27 years of age, have no history of chronic illness, are a non-smoker and fall within one of the five groups listed below:
- Have had a concussion within 24-48 hrs;
- Are having persistent symptoms of concussion (longer than 3 months but no longer than 6 months);
- Have had a bone fracture within the past 24-48 hrs, but no concussion;
- Are a healthy active individual (no chronic conditions, no concussions, no active injuries);
- Are a boxer who has recently been in a bout (within 24 – 48 hours) with no bone fracture injuries in the last 6 months
Interested in participating in our study?
Contact : firstname.lastname@example.org