Effects of Multiple Concussions in Retired NHL Players

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

Detailed Description
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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.

Official Title
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Later Life Cognitive Impairment, Proprioception, and Biomarkers in Former NHL Players Who Suffered Multiple Concussions

Conditions
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Cognitive Deficits, Proprioceptive Disorders

Intervention / Treatment
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* Other: Sensory Organization Test
* Genetic: Biomarkers
* Other: Conners' Adult ADHD Rating Scale (CAARS)
* Other: Depression Scale
* Other: Cognitive Assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Retired professional NHL player History or reported concussion and concussion like symptoms Exclusion Criteria: Any neurological condition Non sport related head trauma

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case / Retired NHL Players<br>All interventions for this group are described below: Sensory Organization Test (SOT): Balance and proprioception test Connor's Adult ADHD Rating Scale (CAARS): A computer based questionnaire used to measure the presence of adult attention deficit hyperactivity disorder. Beck's Depression Inventory: A 21 question multiple choice self report measuring the severity of depression Patient Health Questionnaire 9 (PHQ-9): Self administered screening questionnaire for mental health disorders Montreal Cognitive Assessment (MoCA): A validated screening tool to assess cognitive mild impairment Blood/Urine/Saliva Biomarker analysis: These samples will be analyzed for relevant biomarkers | Other: Sensory Organization Test<br>* Balance and proprioception test<br>Genetic: Biomarkers<br>* Blood, urine, and saliva biomarkers<br>Other: Conners' Adult ADHD Rating Scale (CAARS)<br>* Adult ADHD rating scale<br>Other: Depression Scale<br>* Becks Depression Inventory and Patient Health Questionnaire 9 (PHQ-9)<br>Other: Cognitive Assessment<br>* Montreal Cognitive Assessment (MoCA)<br>|
| Age Matched Controls<br>All interventions for this group are described below: Sensory Organization Test (SOT): Balance and proprioception test Connor's Adult ADHD Rating Scale (CAARS): A computer based questionnaire used to measure the presence of adult attention deficit hyperactivity disorder. Beck's Depression Inventory: A 21 question multiple choice self report measuring the severity of depression Patient Health Questionnaire 9 (PHQ-9): Self administered screening questionnaire for mental health disorders Montreal Cognitive Assessment (MoCA): A validated screening tool to assess cognitive mild impairment Blood/Urine/Saliva Biomarker analysis: These samples will be analyzed for relevant biomarkers | Other: Sensory Organization Test<br>* Balance and proprioception test<br>Genetic: Biomarkers<br>* Blood, urine, and saliva biomarkers<br>Other: Conners' Adult ADHD Rating Scale (CAARS)<br>* Adult ADHD rating scale<br>Other: Depression Scale<br>* Becks Depression Inventory and Patient Health Questionnaire 9 (PHQ-9)<br>Other: Cognitive Assessment<br>* Montreal Cognitive Assessment (MoCA)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognition assessed with the Montreal Cognitive Assessment Scale | Montreal Cognitive Assessment Scale | 10 minutes | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NHL, Concussion, Biomarkers