Cerebral Blood Flow Regulation and Concussions
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|ClinicalTrials.gov Identifier: NCT02754206|
Recruitment Status : Recruiting
First Posted : April 28, 2016
Last Update Posted : October 4, 2018
|Condition or disease|
|Brain Concussion Post-Concussion Syndrome|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Association Between Brain Blood Flow Regulation, Cognition, and Balance in Sports-Related Concussion|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||January 2021|
Subjects who are collegiate level athletes who do not have a concussion and are currently playing a contact-collision sport.
Subjects who have recently suffered a sports-related concussion and are currently a collegiate athlete playing a contact-collision sport.
- Cerebral blood flow regulation [ Time Frame: Change in Control, 3 days post concussion, 21 days post concussion, and 3 months post concussion ]Subject's cerebral blood flow regulation (cm/sec) at rest, during a cognitive test, and during a breathing test will be measured.
- Blood Biomarkers [ Time Frame: Control, 3 days post concussion, 21 days post concussion, 3 months post concussion ]Subjects will have their blood drawn so investigators can look at biomarkers in their blood. The biomarkers will be Tau, a-Spectrin N-Terminal Fragment, Neuron-specific enolase, Ubiquitin C-Terminal hydrolase L1, S100B, and Glial fibrillary acidic protein.
- Memory Function Test [ Time Frame: Control, 3 days post concussion, 21 days post concussion, 3 months post concussion ]Subjects will be given paper tests to test their memory function.
- Balance Test [ Time Frame: Control, 3 days post concussion, 21 days post concussion, 3 months post concussion ]Subjects balance will be measured using a force plate.
- Orthostatic Tolerance Test [ Time Frame: Control, 3 days post concussion, 21 days post concussion, 3 months post concussion ]Subjects physiological measurements will be measured as the move from a seated position to a standing position.
- Cerebral Vasoreactivity [ Time Frame: Control, 3 days post concussion, 21 days post concussion, 3 months post concussion ]Subjects will breathe normal air, a 8% carbon dioxide gas mixture, and hyperventilate.
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): NCT02754206
|Contact: Sushmita A Purkayastha, Ph.Dfirstname.lastname@example.org|
|United States, Texas|
|Southern Methodist University||Recruiting|
|Dallas, Texas, United States, 75205|
|Contact: Sandy A Oswalt 214-768-4036 email@example.com|
|Principal Investigator: Sushmita Purkayastha, Ph.D|
|Principal Investigator:||Sushmita Purkayastha, Ph.D||Southern Methodist University|