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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02746523
Other study ID # BHS-1170
Secondary ID
Status Terminated
Phase N/A
First received April 8, 2016
Last updated July 25, 2017
Start date March 2016
Est. completion date March 2017

Study information

Verified date July 2017
Source New York Institute of Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To investigate long term affects of multiple concussions on the cognition, balance, proprioception, and biomarkers in retired National Hockey League players


Description:

This research study will collect data for each subject in one single visit. During the visit the subject will be asked to consent to the study which is estimated to take approximately 10 minutes. A medical history will be obtained, taking approximately 15 minutes. Blood, urine, and cheek swabs will be collected for approximately 15 minutes. The PHQ-9, Becks Depression Inventory, Connors Adult ADHD Rating Scale (CAARS™), and Montreal Cognitive Assessment (MoCA) will be administered, these assessments combined are estimated to take 50 minutes. Lastly, patients will be asked to complete a Sensory Organization Test (SOT) which takes approximately 15 minutes. There are only licensed health professionals working on this project that will respect your privacy and conduct this trial following all HIPPA and clinical research guidelines.


Recruitment information / eligibility

Status Terminated
Enrollment 6
Est. completion date March 2017
Est. primary completion date March 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria:

- Retired professional NHL player

- History or reported concussion and concussion like symptoms

Exclusion Criteria:

- Any neurological condition

- Non sport related head trauma

Study Design


Intervention

Other:
Sensory Organization Test
Balance and proprioception test
Genetic:
Biomarkers
Blood, urine, and saliva biomarkers
Other:
Conners' Adult ADHD Rating Scale (CAARS)
Adult ADHD rating scale
Depression Scale
Becks Depression Inventory and Patient Health Questionnaire 9 (PHQ-9)
Cognitive Assessment
Montreal Cognitive Assessment (MoCA)

Locations

Country Name City State
United States NYIT Old Westbury New York

Sponsors (1)

Lead Sponsor Collaborator
New York Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cognition assessed with the Montreal Cognitive Assessment Scale Montreal Cognitive Assessment Scale 10 minutes
Secondary Beck's Depression Inventory A 21 question multiple choice self report inventory measuring the severity of depression 10 minutes
Secondary Adult Attention Deficit assessed with the Connors' Adult Attention Deficit Disorder Rating Scale Connors' Adult Attention Deficit Disorder Rating Scale 10 minutes
Secondary Proprioception/Postural Stability assessed with the Sensory Organization Test Sensory Organization Test 15 minutes
Secondary Human Interleukin-6 (IL-6) Blood (20 cc), Urine (40 cc): Total volume for all proposed biomarkers Marker type: Inflammation 5 Minutes
Secondary Patient Health Questionnaire 9 (PHQ-9) Self administered screening and diagnostic questionnaire for mental health disorders 5 minutes
Secondary Interleukin 7 (IL-7) Blood (20 cc), Urine (40 cc): Total volume for all proposed biomarkers Marker Type: Inflammation 5 minutes
Secondary Human 8-hydroxy-2' -deoxyguanosine (8-OHdG) Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: Oxidative stress on DNA 5 minutes
Secondary 3-nitrotyrosine Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: Oxidative stress on lipids 5 minutes
Secondary 8-iso-Prostaglandin F2a Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: oxidative stress on lipids 5 minutes
Secondary Dityrosine Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: Oxidative Stress on protein 5 minutes
Secondary Apolipoprotein E-4 Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: Traumatic brain injury 5 minutes
Secondary Complement Component 3 B (C3b) Blood (20 cc), Urine (40 cc), Saliva (5 cc): Total volume for all proposed Marker Type: Complement system 5 minutes
Secondary MicroRNA miR132 Blood (20 cc), Urine (40 cc), Saliva (5 cc) Total volume for all proposed Marker Type: MicroRNA 5 minutes
Secondary MicroRNA miR183 Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: MicroRNA 5 minutes
Secondary S-100B Calcium binding protein Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: Blood brain barrier damage 5 minutes
Secondary Brain derived neurotrophic factor (BDNF) Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: Inflammation 5 minutes
Secondary Amyloid beta 40 Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: Neurodegeneration 5 minutes
Secondary Total Tau Protein (tTAU) Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: Traumatic brain injury 5 minutes
Secondary Eco-Rna Species Blood (20 cc), Urine (40 cc),Saliva (5 cc): Total volume for all proposed Marker Type: Exo-RNA 5 minutes
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