Effects of Multiple Concussions in Retired NHL Players (NHL)

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

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

Study Overview

• Status: Terminated
• Conditions: Proprioceptive Disorders; Cognitive Deficits
• Intervention / Treatment: Other: Sensory Organization Test; Genetic: Biomarkers; Other: Conners' Adult ADHD Rating Scale (CAARS); Other: Depression Scale; Other: Cognitive Assessment

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 Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

• United States
  • New York
    • Old Westbury, New York, United States, 11568
      • NYIT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Retired NHL Players who suffered multiple concussions and age matched controls

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case / Retired NHL Players; 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; Balance and proprioception test; Genetic: Biomarkers; Blood, urine, and saliva biomarkers; Other: Conners' Adult ADHD Rating Scale (CAARS); Adult ADHD rating scale; Other: Depression Scale; Becks Depression Inventory and Patient Health Questionnaire 9 (PHQ-9); Other: Cognitive Assessment; Montreal Cognitive Assessment (MoCA)
Age Matched Controls; 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; Balance and proprioception test; Genetic: Biomarkers; Blood, urine, and saliva biomarkers; Other: Conners' Adult ADHD Rating Scale (CAARS); Adult ADHD rating scale; Other: Depression Scale; Becks Depression Inventory and Patient Health Questionnaire 9 (PHQ-9); Other: Cognitive Assessment; Montreal Cognitive Assessment (MoCA)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: New York Institute of Technology
• Investigators: Study Chair: Brian Harper, MD, NYIT-COM

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (ACTUAL): March 1, 2017
• Study Completion (ACTUAL): March 1, 2017

Study Registration Dates

• First Submitted: April 8, 2016
• First Submitted That Met QC Criteria: April 18, 2016
• First Posted (ESTIMATE): April 21, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2017
• Last Update Submitted That Met QC Criteria: July 25, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Concussion; NHL; Biomarkers
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurocognitive Disorders; Sensation Disorders; Cognitive Dysfunction; Cognition Disorders; Somatosensory Disorders
• Other Study ID Numbers: BHS-1170

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participants data will not be shared with individuals