Cerebral Blood Flow Regulation and Concussions

September 7, 2021 updated by: Heather McClary, Southern Methodist University

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

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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

79

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75205
        • Southern Methodist University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Collegiate Athletes who are currently playing a contact-collision sport.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change in Control, 3 days post concussion, 21 days post concussion, and 3 months post concussion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Control, 3 days post concussion, 21 days post concussion, 3 months post concussion
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.
Control, 3 days post concussion, 21 days post concussion, 3 months post concussion
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.
Control, 3 days post concussion, 21 days post concussion, 3 months post concussion
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.
Control, 3 days post concussion, 21 days post concussion, 3 months post concussion
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.
Control, 3 days post concussion, 21 days post concussion, 3 months post concussion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southern Methodist University

Investigators

  • Principal Investigator: Sushmita Purkayastha, Ph.D, Southern Methodist University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

September 1, 2021

Study Completion (Actual)

September 1, 2021

Study Registration Dates

First Submitted

April 20, 2016

First Submitted That Met QC Criteria

April 25, 2016

First Posted (Estimate)

April 28, 2016

Study Record Updates

Last Update Posted (Actual)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 7, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SouthernMethodist

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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