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Effects of Multiple Concussions in Retired NHL Players

Terminated
Conditions
Cognitive Deficits
Proprioceptive Disorders
Interventions
Other: Sensory Organization Test
Genetic: Biomarkers
Other: Conners' Adult ADHD Rating Scale (CAARS)
Other: Depression Scale
Other: Cognitive Assessment
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.

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
Arm && Interventions
GroupInterventionDescription
Case / Retired NHL PlayersDepression ScaleAll 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
Case / Retired NHL PlayersCognitive AssessmentAll 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
Age Matched ControlsSensory Organization TestAll 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
Case / Retired NHL PlayersSensory Organization TestAll 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
Case / Retired NHL PlayersBiomarkersAll 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
Case / Retired NHL PlayersConners' Adult ADHD Rating Scale (CAARS)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
Age Matched ControlsBiomarkersAll 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
Age Matched ControlsCognitive AssessmentAll 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
Age Matched ControlsConners' Adult ADHD Rating Scale (CAARS)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
Age Matched ControlsDepression ScaleAll 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
Primary Outcome Measures
NameTimeMethod
Cognition assessed with the Montreal Cognitive Assessment Scale10 minutes

Montreal Cognitive Assessment Scale

Secondary Outcome Measures
NameTimeMethod
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 protein5 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 Scale10 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 F2a5 minutes

Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: oxidative stress on lipids

Dityrosine5 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 Test15 minutes

Sensory Organization Test

MicroRNA miR1325 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 Inventory10 minutes

A 21 question multiple choice self report inventory measuring the severity of depression

3-nitrotyrosine5 minutes

Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: Oxidative stress on lipids

Apolipoprotein E-45 minutes

Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: Traumatic brain injury

MicroRNA miR1835 minutes

Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: MicroRNA

Amyloid beta 405 minutes

Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: Neurodegeneration

Eco-Rna Species5 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

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