Cerebral Blood Flow Regulation and Concussions

NCT02754206 | Terminated

• 1 other identifier: SouthernMethodist
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Concussion; Post-Concussion Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Blood Biomarkers

  Control, 3 days post concussion, 21 days post concussion, 3 months post concussion

• Memory Function Test

  Control, 3 days post concussion, 21 days post concussion, 3 months post concussion

• Balance Test

  Control, 3 days post concussion, 21 days post concussion, 3 months post concussion

• Orthostatic Tolerance Test

  Control, 3 days post concussion, 21 days post concussion, 3 months post concussion

• Cerebral Vasoreactivity

  Control, 3 days post concussion, 21 days post concussion, 3 months post concussion

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Southern Methodist University: lead

Study Sites (1)

Southern Methodist University

Dallas, Texas, 75205, United States

Location

Related Publications (1)

• Purkayastha S, Adair H, Woodruff A, Ryan LJ, Williams B, James E, Bell KR. Balance Testing Following Concussion: Postural Sway versus Complexity Index. PM R. 2019 Nov;11(11):1184-1192. doi: 10.1002/pmrj.12129. Epub 2019 Apr 3.

  PMID: 30729729 DERIVED

MeSH Terms

Conditions

Brain Concussion; Post-Concussion Syndrome

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Sushmita Purkayastha, Ph.D

  Southern Methodist University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research Compliance

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: April 28, 2016
• Study Start: January 1, 2016
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 14, 2021

Record last verified: 2021-09

Locations

US (1)