Effects of Multiple Concussions in Retired NHL Players

NCT ID: NCT02746523

Last Updated: 2017-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-03-31

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.

Conditions

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Cognitive Deficits Proprioceptive Disorders

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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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

Sensory Organization Test

Intervention Type OTHER

Balance and proprioception test

Biomarkers

Intervention Type GENETIC

Blood, urine, and saliva biomarkers

Conners' Adult ADHD Rating Scale (CAARS)

Intervention Type OTHER

Adult ADHD rating scale

Depression Scale

Intervention Type OTHER

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

Cognitive Assessment

Intervention Type OTHER

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

Sensory Organization Test

Intervention Type OTHER

Balance and proprioception test

Biomarkers

Intervention Type GENETIC

Blood, urine, and saliva biomarkers

Conners' Adult ADHD Rating Scale (CAARS)

Intervention Type OTHER

Adult ADHD rating scale

Depression Scale

Intervention Type OTHER

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

Cognitive Assessment

Intervention Type OTHER

Montreal Cognitive Assessment (MoCA)

Interventions

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Sensory Organization Test

Balance and proprioception test

Intervention Type OTHER

Biomarkers

Blood, urine, and saliva biomarkers

Intervention Type GENETIC

Conners' Adult ADHD Rating Scale (CAARS)

Adult ADHD rating scale

Intervention Type OTHER

Depression Scale

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

Intervention Type OTHER

Cognitive Assessment

Montreal Cognitive Assessment (MoCA)

Intervention Type OTHER

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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New York Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Joanne DiFrancisco-Donoghue

Assistant Professor, Ph. D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brian Harper, MD

Role: STUDY_CHAIR

NYIT-COM

Locations

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NYIT

Old Westbury, New York, United States

Site Status

Countries

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United States

Other Identifiers

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BHS-1170

Identifier Type: -

Identifier Source: org_study_id

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