Cerebral Blood Flow Regulation and Concussions

Terminated

• Conditions: Brain Concussion; Post-Concussion Syndrome

• Registration Number: NCT02754206
• Lead Sponsor: Southern Methodist University

Brief Summary

The purpose of this study is to understand how biochemical markers in blood, balance disturbances, and cognitive performance are related to brain blood flow changes after a concussion.

Detailed Description

Comparisons will be made between control data and data following a concussion collected from athletes participating in contact-collision sports. For those suffering a concussion, comparisons will be made between day 3 (acute phase), day 21 (recovery phase), and 3 months post-concussion.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-04-20
• Study First Submitted QC: 2016-04-25
• Study First Posted: 2016-04-28
• Status Verified: 2021-09
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01
• Last Update Submitted: 2021-09-07
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

• Student athletes actively participating in collegiate sports. Subjects should be wiling to provide informed consent for participation in the study.

Exclusion Criteria

• Participants who are unable to play as a result of injury. Presence of irregular heart beat.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cerebral blood flow regulation	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.

Secondary Outcome Measures

Name	Time	Method
Balance Test	Control, 3 days post concussion, 21 days post concussion, 3 months post concussion	Subjects balance will be measured using a force plate.
Blood Biomarkers	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.
Cerebral Vasoreactivity	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.
Orthostatic Tolerance Test	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.
Memory Function Test	Control, 3 days post concussion, 21 days post concussion, 3 months post concussion	Subjects will be given paper tests to test their memory function.

Trial Locations

Locations (1)

Southern Methodist University; 🇺🇸 Dallas, Texas, United States