Clinical trial NCT02746523: Effects of Multiple Concussions in Retired NHL Players
Official title: Later Life Cognitive Impairment, Proprioception, and Biomarkers in Former NHL Players Who Suffered Multiple Concussions
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cognitive Deficits
Proprioceptive Disorders
Keywords: NHL
Concussion
Biomarkers
Lead sponsor: New York Institute of Technology
Sponsor class: OTHER
First posted: 2016-04-21
Enrollment: 6
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retired NHL Players who suffered multiple concussions and age matched controls

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Any neurological condition
* Non sport related head trauma

Primary outcomes:
measure: Cognition assessed with the Montreal Cognitive Assessment Scale
timeFrame: 10 minutes
Secondary outcomes:
measure: Beck's Depression Inventory
timeFrame: 10 minutes
measure: Adult Attention Deficit assessed with the Connors' Adult Attention Deficit Disorder Rating Scale
timeFrame: 10 minutes
measure: Proprioception/Postural Stability assessed with the Sensory Organization Test
timeFrame: 15 minutes
measure: Human Interleukin-6 (IL-6)
timeFrame: 5 Minutes
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: 5 minutes
measure: Interleukin 7 (IL-7)
timeFrame: 5 minutes
measure: Human 8-hydroxy-2' -deoxyguanosine (8-OHdG)
timeFrame: 5 minutes
measure: 3-nitrotyrosine
timeFrame: 5 minutes
measure: 8-iso-Prostaglandin F2a
timeFrame: 5 minutes
measure: Dityrosine
timeFrame: 5 minutes
measure: Apolipoprotein E-4
timeFrame: 5 minutes
measure: Complement Component 3 B (C3b)
timeFrame: 5 minutes
measure: MicroRNA miR132
timeFrame: 5 minutes
measure: MicroRNA miR183
timeFrame: 5 minutes
measure: S-100B Calcium binding protein
timeFrame: 5 minutes
measure: Brain derived neurotrophic factor (BDNF)
timeFrame: 5 minutes
measure: Amyloid beta 40
timeFrame: 5 minutes
measure: Total Tau Protein (tTAU)
timeFrame: 5 minutes
measure: Eco-Rna Species
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Old Westbury
country: United States
facility: NYIT
state: New York
Study officials:
affiliation: NYIT-COM
name: Brian Harper, MD
role: STUDY_CHAIR
References: