Cerebral Blood Flow Regulation and Concussions

Brain Concussion Clinical Trial

Official title:

Association Between Brain Blood Flow Regulation, Cognition, and Balance in Sports-Related Concussion

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02754206
• Other study ID #: SouthernMethodist
• Status: Terminated
• Start date: January 2016
• Est. completion date: September 1, 2021

Study information

• Verified date: September 2021
• Source: Southern Methodist University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 79
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Concussion
• Post-Concussion Syndrome

Locations

Country	Name	City	State
United States	Southern Methodist University	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Southern Methodist University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral blood flow regulation	Subject's cerebral blood flow regulation (cm/sec) at rest, during a cognitive test, and during a breathing test will be measured.	Change in Control, 3 days post concussion, 21 days post concussion, and 3 months post concussion
Secondary	Blood Biomarkers	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.	Control, 3 days post concussion, 21 days post concussion, 3 months post concussion
Secondary	Memory Function Test	Subjects will be given paper tests to test their memory function.	Control, 3 days post concussion, 21 days post concussion, 3 months post concussion
Secondary	Balance Test	Subjects balance will be measured using a force plate.	Control, 3 days post concussion, 21 days post concussion, 3 months post concussion
Secondary	Orthostatic Tolerance Test	Subjects physiological measurements will be measured as the move from a seated position to a standing position.	Control, 3 days post concussion, 21 days post concussion, 3 months post concussion
Secondary	Cerebral Vasoreactivity	Subjects will breathe normal air, a 8% carbon dioxide gas mixture, and hyperventilate.	Control, 3 days post concussion, 21 days post concussion, 3 months post concussion