Effects of Multiple Concussions in Retired NHL Players

Proprioceptive Disorders Clinical Trial

— NHL  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02746523
• Other study ID #: BHS-1170
• Status: Terminated
• Phase: N/A
• First received: April 8, 2016
• Last updated: July 25, 2017
• Start date: March 2016
• Est. completion date: March 2017

Study information

• Verified date: July 2017
• Source: New York Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Retired professional NHL player

• History or reported concussion and concussion like symptoms

Exclusion Criteria:

• Any neurological condition

• Non sport related head trauma

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Deficits
• Proprioceptive Disorders
• Somatosensory Disorders

Intervention

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
• Depression Scale
Becks Depression Inventory and Patient Health Questionnaire 9 (PHQ-9)
• Cognitive Assessment
Montreal Cognitive Assessment (MoCA)

Locations

Country	Name	City	State
United States	NYIT	Old Westbury	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognition assessed with the Montreal Cognitive Assessment Scale	Montreal Cognitive Assessment Scale	10 minutes
Secondary	Beck's Depression Inventory	A 21 question multiple choice self report inventory measuring the severity of depression	10 minutes
Secondary	Adult Attention Deficit assessed with the Connors' Adult Attention Deficit Disorder Rating Scale	Connors' Adult Attention Deficit Disorder Rating Scale	10 minutes
Secondary	Proprioception/Postural Stability assessed with the Sensory Organization Test	Sensory Organization Test	15 minutes
Secondary	Human Interleukin-6 (IL-6)	Blood (20 cc), Urine (40 cc): Total volume for all proposed biomarkers Marker type: Inflammation	5 Minutes
Secondary	Patient Health Questionnaire 9 (PHQ-9)	Self administered screening and diagnostic questionnaire for mental health disorders	5 minutes
Secondary	Interleukin 7 (IL-7)	Blood (20 cc), Urine (40 cc): Total volume for all proposed biomarkers Marker Type: Inflammation	5 minutes
Secondary	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
Secondary	3-nitrotyrosine	Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: Oxidative stress on lipids	5 minutes
Secondary	8-iso-Prostaglandin F2a	Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: oxidative stress on lipids	5 minutes
Secondary	Dityrosine	Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: Oxidative Stress on protein	5 minutes
Secondary	Apolipoprotein E-4	Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: Traumatic brain injury	5 minutes
Secondary	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
Secondary	MicroRNA miR132	Blood (20 cc), Urine (40 cc), Saliva (5 cc) Total volume for all proposed Marker Type: MicroRNA	5 minutes
Secondary	MicroRNA miR183	Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: MicroRNA	5 minutes
Secondary	S-100B Calcium binding protein	Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: Blood brain barrier damage	5 minutes
Secondary	Brain derived neurotrophic factor (BDNF)	Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: Inflammation	5 minutes
Secondary	Amyloid beta 40	Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: Neurodegeneration	5 minutes
Secondary	Total Tau Protein (tTAU)	Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: Traumatic brain injury	5 minutes
Secondary	Eco-Rna Species	Blood (20 cc), Urine (40 cc),Saliva (5 cc): Total volume for all proposed Marker Type: Exo-RNA	5 minutes