Effects of Multiple Concussions in Retired NHL Players

Terminated

• Conditions: Cognitive Deficits; Proprioceptive Disorders

• Registration Number: NCT02746523
• Lead Sponsor: New York Institute of Technology

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-04-08
• Study First Submitted QC: 2016-04-18
• Study First Posted: 2016-04-21
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-25
• Last Update Posted: 2017-07-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 6

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognition assessed with the Montreal Cognitive Assessment Scale	10 minutes	Montreal Cognitive Assessment Scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

NYIT; 🇺🇸 Old Westbury, New York, United States