Poly-omic Predictors of Symptom Duration and Recovery for Adolescent Concussion
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|ClinicalTrials.gov Identifier: NCT04582682|
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : January 26, 2021
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||750 participants|
|Official Title:||Poly-omic Predictors of Symptom Duration and Recovery for Adolescent Concussion|
|Actual Study Start Date :||January 18, 2021|
|Estimated Primary Completion Date :||January 2024|
|Estimated Study Completion Date :||January 2026|
- Presence or absence of persistent post-concussive symptoms (PPCS) 30 days after injury [ Time Frame: 30 days after injury ]PPCS will be defined by persistence of at least 3 symptoms on day 30, compared with pre-injury state, which will be determined from pre-injury symptoms reported at enrollment using the Post-Concussion Symptom Inventory (PCSI). PCSI is a self reported survey that focus on symptoms in the cognitive, emotional, sleep, and physical domains. This form is called the "Sport Concussion Assessment Tool- 5th Edition" and symptoms are scored from 0 to 6 with 0 being no symptom and 6 being severe. A high score is indicative of a subject experiencing the worst they have experienced this symptom.
- Presence or absence of concussion recovery 30 days after injury [ Time Frame: 30 days after injury ]Defined as a score of 0 (no difference) on item 22 of the Post-Concussion Symptom Inventory (PCSI); "To what degree do you feel 'differently' than before your injury?" This patient-oriented outcome measure relies on the individual's experience of symptoms to define recovery.PCSI is a self reported survey that focus on symptoms in the cognitive, emotional, sleep, and physical domains. This form is called the "Sport Concussion Assessment Tool- 5th Edition" and symptoms are scored from 0 to 6 with 0 being no symptom and 6 being severe.
- Concussion symptom burden and severity [ Time Frame: Within 48 hours of injury, 7 days post-injury, and 30 days post-injury ]measured as ranked scores by the PCSI at enrollment, PCSI is a self reported survey that focus on symptoms in the cognitive, emotional, sleep, and physical domains. This form is called the "Sport Concussion Assessment Tool- 5th Edition" and symptoms are scored from 0 to 6 with 0 being no symptom and 6 being severe. Symptom burden will be number of symptoms experiencing and severity will be how sever those symptoms are on the 0-6 scale
- Orientation, immediate memory, concentration, and delayed recall performance [ Time Frame: Within 48 hours of injury ]measured as ranked scores by the Standardized Assessment of Concussion (SAC) at enrollment, this test scores cognition using orientation (ex. what is todays date), immediate memory (repeating a list of 10 words), concentration (repeating a list of 3-6 numbers backwards and the months of the year backwards), and delayed recall (recalling the list of 10 words from earlier). Subject receives points for each correct answer with lower scores meaning the concussion has affect the subject more
- Balance performance [ Time Frame: Within 48 hours of injury ]measured by the Balance Error Scoring System (BESS) at enrollment, which includes scoring balance on foam and firm surfaces in three different stances for 20 seconds with eyes closed. One point is give per error. An error is credited to the subject when any of the following occur: moving the hands off of the iliac crests, opening the eyes, step stumble or fall, abduction or flexion of the hip beyond 30, lifting the forefoot or heel off of the testing surface, remaining out of the proper testing position for greater than 5 seconds. The maximum total number of errors for any single condition is 10 with 3 conditions (double leg, single leg and tandem stances) each on each foam and firm surfaces the total maximum BESS score is 60 and the lowest score one can achieve is 0. With 0 being the best and 60 being the worst.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04582682
|Contact: Steven Hicks, MD, PhDfirstname.lastname@example.org|
|Contact: Brennen Harding, MS||7175310003 ext email@example.com|
|United States, Pennsylvania|
|Penn State Milton S. Hershey Medical Center||Recruiting|
|Hershey, Pennsylvania, United States, 17033|
|Contact: Brennen Harding, MS 717-531-0003 ext 280848 firstname.lastname@example.org|
|Sub-Investigator: Steven Hicks, MD, PhD|
|Principal Investigator:||Steve Hicks, MD, PhD||Penn State University, College of Medicine|