Brain ConcussionNCT02754206
Cerebral Blood Flow Regulation and Concussions
An observational study of Brain Concussion and Post-Concussion Syndrome, run by Southern Methodist University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Concussion, Post-Concussion Syndrome
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Collegiate Athletes who are currently playing a contact-collision sport.
Who may be able to join
- Student athletes actively participating in collegiate sports. Subjects should be wiling to provide informed consent for participation in the study.
Who cannot join
- Participants who are unable to play as a result of injury. Presence of irregular heart beat.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Brain Concussion, Post-Concussion Syndrome
- Medical subject headings
- Brain Concussion, Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in Control, 3 days post concussion, 21 days post concussion, and 3 months post concussion
Secondary outcomes (5)
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.
Measured: Control, 3 days post concussion, 21 days post concussion, 3 months post concussion
Memory Function Test
Subjects will be given paper tests to test their memory function.
Measured: Control, 3 days post concussion, 21 days post concussion, 3 months post concussion
Balance Test
Subjects balance will be measured using a force plate.
Measured: Control, 3 days post concussion, 21 days post concussion, 3 months post concussion
Orthostatic Tolerance Test
Subjects physiological measurements will be measured as the move from a seated position to a standing position.
Measured: Control, 3 days post concussion, 21 days post concussion, 3 months post concussion
Cerebral Vasoreactivity
Subjects will breathe normal air, a 8% carbon dioxide gas mixture, and hyperventilate.
Measured: Control, 3 days post concussion, 21 days post concussion, 3 months post concussion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startJan 2016
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Why it stopped: PI left university and IRB protocol closed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain ConcussionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Methodist University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather McClary, Southern Methodist University
- Investigators
- Sushmita Purkayastha, Ph.D, Principal investigator, Southern Methodist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754206
- Sponsor's protocol ID
- SouthernMethodist
- Status last verified
- Sep 2021
- First submitted
- 20 Apr 2016
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30729729
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Brain Blood Flow Regulation, Cognition, and Balance in Sports-Related Concussion
- ClinicalTrials.gov ID
- NCT02754206
- Acronym / sponsor ID
- SouthernMethodist
- Conditions
- Brain Concussion, Post-Concussion Syndrome
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left university and IRB protocol closed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Southern Methodist UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Collegiate Athletes who are currently playing a contact-collision sport.
Key inclusion criteria (1 listed)
- Student athletes actively participating in collegiate sports. Subjects should be wiling to provide informed consent for participation in the study.
Key exclusion criteria (1 listed)
- Participants who are unable to play as a result of injury. Presence of irregular heart beat.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Blood Biomarkers
Time frame: 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
Balance Test
Time frame: 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
Cerebral Vasoreactivity
Time frame: Control, 3 days post concussion, 21 days post concussion, 3 months post concussion
Results and safety
The study was stopped early (reason given: PI left university and IRB protocol closed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Derived from this study: PubMed 30729729Purkayastha 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sushmita Purkayastha, Ph.D principal investigator
Southern Methodist University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Concussion and Post-Concussion Syndrome, run by Southern Methodist University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI left university and IRB protocol closed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral blood flow regulation (time frame: Change in Control, 3 days post concussion, 21 days post concussion, and 3 months post concussion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02754206, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.