Effects of Multiple Concussions in Retired NHL Players

NCT02746523 | Terminated

• 1 other identifier: BHS-1170
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cognitive Deficits; Proprioceptive Disorders

Keywords

NHL; Concussion; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Cognition assessed with the Montreal Cognitive Assessment Scale

  Montreal Cognitive Assessment Scale

  10 minutes

Secondary Outcomes (19)

• Beck's Depression Inventory

  10 minutes

• Adult Attention Deficit assessed with the Connors' Adult Attention Deficit Disorder Rating Scale

  10 minutes

• Proprioception/Postural Stability assessed with the Sensory Organization Test

  15 minutes

• Human Interleukin-6 (IL-6)

  5 Minutes

• Patient Health Questionnaire 9 (PHQ-9)

  5 minutes

Study Arms (2)

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; Genetic: Biomarkers; Other: Conners' Adult ADHD Rating Scale (CAARS); Other: Depression Scale; Other: Cognitive Assessment

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; Genetic: Biomarkers; Other: Conners' Adult ADHD Rating Scale (CAARS); Other: Depression Scale; Other: Cognitive Assessment

Interventions

Sensory Organization Test OTHER

Balance and proprioception test

Age Matched Controls; Case / Retired NHL Players

Biomarkers GENETIC

Blood, urine, and saliva biomarkers

Age Matched Controls; Case / Retired NHL Players

Conners' Adult ADHD Rating Scale (CAARS) OTHER

Adult ADHD rating scale

Age Matched Controls; Case / Retired NHL Players

Depression Scale OTHER

Becks Depression Inventory and Patient Health Questionnaire 9 (PHQ-9)

Age Matched Controls; Case / Retired NHL Players

Cognitive Assessment OTHER

Montreal Cognitive Assessment (MoCA)

Age Matched Controls; Case / Retired NHL Players

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Retired NHL Players who suffered multiple concussions and age matched controls

You may qualify if:

• Retired professional NHL player
• History or reported concussion and concussion like symptoms

You may not qualify if:

• Any neurological condition
• Non sport related head trauma

Sponsors & Collaborators

• New York Institute of Technology: lead

Study Sites (1)

NYIT

Old Westbury, New York, 11568, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, saliva, nasal swab, mouth swab

MeSH Terms

Conditions

Cognition Disorders; Somatosensory Disorders; Brain Concussion

Interventions

Biomarkers; Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Biological Factors; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Brian Harper, MD

  NYIT-COM

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Ph. D.

Study Record Dates

• First Submitted: April 8, 2016
• First Posted: April 21, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: July 28, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)