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Cerebral Blood Flow Regulation and Concussions

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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
Sponsor:
Information provided by (Responsible Party):
Heather McClary, Southern Methodist University

Study Description
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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.

Condition or disease
Brain Concussion Post-Concussion Syndrome

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 Design
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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
Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Collegiate Athletes who are currently playing a contact-collision sport.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Texas
Southern Methodist University
Dallas, Texas, United States, 75205
Sponsors and Collaborators
Southern Methodist University
Investigators
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Principal Investigator: Sushmita Purkayastha, Ph.D Southern Methodist University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Additional relevant MeSH terms:
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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