Cerebral Blood Flow Regulation and Concussions
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02754206 |
Recruitment Status :
Terminated
(PI left university and IRB protocol closed)
First Posted : April 28, 2016
Last Update Posted : September 14, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Brain Concussion Post-Concussion Syndrome |
Study Type : | Observational |
Actual Enrollment : | 79 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Association Between Brain Blood Flow Regulation, Cognition, and Balance in Sports-Related Concussion |
Study Start Date : | January 2016 |
Actual Primary Completion Date : | September 1, 2021 |
Actual Study Completion Date : | September 1, 2021 |
Group/Cohort |
---|
Control
Subjects who are collegiate level athletes who do not have a concussion and are currently playing a contact-collision sport.
|
Concussed
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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 30 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.

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
United States, Texas | |
Southern Methodist University | |
Dallas, Texas, United States, 75205 |
Principal Investigator: | Sushmita Purkayastha, Ph.D | Southern Methodist University |
Responsible Party: | Heather McClary, Director of Research Compliance, Southern Methodist University |
ClinicalTrials.gov Identifier: | NCT02754206 |
Other Study ID Numbers: |
SouthernMethodist |
First Posted: | April 28, 2016 Key Record Dates |
Last Update Posted: | September 14, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Post-Concussion Syndrome Brain Concussion Head Injuries, Closed Craniocerebral Trauma Trauma, Nervous System Nervous System Diseases |
Wounds and Injuries Wounds, Nonpenetrating Brain Injuries, Traumatic Brain Injuries Brain Diseases Central Nervous System Diseases |