Cognitive DeficitsNHLNCT02746523
Effects of Multiple Concussions in Retired NHL Players
An observational study of Cognitive Deficits and Proprioceptive Disorders, run by New York Institute of Technology at 1 site in United States.
Trial summary
To investigate long term affects of multiple concussions on the cognition, balance, proprioception, and biomarkers in retired National Hockey League players Read more about this study
- Who is it for?
- Ages 40 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cognitive Deficits, Proprioceptive Disorders
- What is being tested?
- Sensory Organization Test, Biomarkers and Conners' Adult ADHD Rating Scale (CAARS)
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Retired NHL Players who suffered multiple concussions and age matched controls
Who may be able to join
- Retired professional NHL player
- History or reported concussion and concussion like symptoms
Who cannot join
- Any neurological condition
- Non sport related head trauma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Cognitive Deficits, Proprioceptive Disorders
- Being tested
- Sensory Organization Test, Biomarkers, Conners' Adult ADHD Rating Scale (CAARS), Depression Scale, Cognitive Assessment
- Keywords
- NHL, Concussion, Biomarkers
- Medical subject headings
- Cognition Disorders, Somatosensory Disorders, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory Organization TestOther
Balance and proprioception test
BiomarkersGenetic
Blood, urine, and saliva biomarkers
Conners' Adult ADHD Rating Scale (CAARS)Other
Adult ADHD rating scale
Depression ScaleOther
Becks Depression Inventory and Patient Health Questionnaire 9 (PHQ-9)
Cognitive AssessmentOther
Montreal Cognitive Assessment (MoCA)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Sensory Organization Test; Genetic: Biomarkers; Other: Conners' Adult ADHD Rating Scale (CAARS); Other: Depression Scale; Other: Cognitive Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition assessed with the Montreal Cognitive Assessment Scale
Montreal Cognitive Assessment Scale
Measured: 10 minutes
Secondary outcomes (19)
Beck's Depression Inventory
A 21 question multiple choice self report inventory measuring the severity of depression
Measured: 10 minutes
Adult Attention Deficit assessed with the Connors' Adult Attention Deficit Disorder Rating Scale
Connors' Adult Attention Deficit Disorder Rating Scale
Measured: 10 minutes
Proprioception/Postural Stability assessed with the Sensory Organization Test
Sensory Organization Test
Measured: 15 minutes
Human Interleukin-6 (IL-6)
Blood (20 cc), Urine (40 cc): Total volume for all proposed biomarkers Marker type: Inflammation
Measured: 5 Minutes
Patient Health Questionnaire 9 (PHQ-9)
Self administered screening and diagnostic questionnaire for mental health disorders
Measured: 5 minutes
Interleukin 7 (IL-7)
Blood (20 cc), Urine (40 cc): Total volume for all proposed biomarkers Marker Type: Inflammation
Measured: 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
Measured: 5 minutes
3-nitrotyrosine
Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: Oxidative stress on lipids
Measured: 5 minutes
8-iso-Prostaglandin F2a
Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: oxidative stress on lipids
Measured: 5 minutes
Dityrosine
Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: Oxidative Stress on protein
Measured: 5 minutes
Apolipoprotein E-4
Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: Traumatic brain injury
Measured: 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
Measured: 5 minutes
MicroRNA miR132
Blood (20 cc), Urine (40 cc), Saliva (5 cc) Total volume for all proposed Marker Type: MicroRNA
Measured: 5 minutes
MicroRNA miR183
Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: MicroRNA
Measured: 5 minutes
S-100B Calcium binding protein
Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: Blood brain barrier damage
Measured: 5 minutes
Brain derived neurotrophic factor (BDNF)
Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: Inflammation
Measured: 5 minutes
Amyloid beta 40
Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: Neurodegeneration
Measured: 5 minutes
Total Tau Protein (tTAU)
Blood (20 cc), Urine (40 cc): Total volume for all proposed Marker Type: Traumatic brain injury
Measured: 5 minutes
Eco-Rna Species
Blood (20 cc), Urine (40 cc),Saliva (5 cc): Total volume for all proposed Marker Type: Exo-RNA
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017
- Study completionMar 2017
Why it stopped: Could not recruit enough subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeficitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanne DiFrancisco-Donoghue, New York Institute of Technology
- Investigators
- Brian Harper, MD, Study chair, NYIT-COM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746523
- Sponsor's protocol ID
- BHS-1170
- Acronym
- NHL
- Status last verified
- Jul 2017
- First submitted
- 8 Apr 2016
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Participants data will not be shared with individuals
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Later Life Cognitive Impairment, Proprioception, and Biomarkers in Former NHL Players Who Suffered Multiple Concussions
- ClinicalTrials.gov ID
- NCT02746523
- Acronym / sponsor ID
- NHL / BHS-1170
- Conditions
- Cognitive Deficits, Proprioceptive Disorders
- Keywords
- NHL, Concussion, Biomarkers
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Could not recruit enough subjects
- Enrolment
- 6 participants (actual)
- Lead sponsor
- New York Institute of TechnologyUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case / Retired NHL Players | – | Other: Sensory Organization Test, Genetic: Biomarkers, Other: Conners' Adult ADHD Rating Scale (CAARS), Other: Depression Scale, Other: Cognitive AssessmentAll 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 |
| Age Matched Controls | – | Other: Sensory Organization Test, Genetic: Biomarkers, Other: Conners' Adult ADHD Rating Scale (CAARS), Other: Depression Scale, Other: Cognitive AssessmentAll 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 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Retired NHL Players who suffered multiple concussions and age matched controls
Key inclusion criteria (2 listed)
- Retired professional NHL player
- History or reported concussion and concussion like symptoms
Key exclusion criteria (2 listed)
- Any neurological condition
- Non sport related head trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory Organization TestBalance and proprioception test | Other | Age Matched Controls, Case / Retired NHL Players |
| BiomarkersBlood, urine, and saliva biomarkers | Genetic | Age Matched Controls, Case / Retired NHL Players |
| Conners' Adult ADHD Rating Scale (CAARS)Adult ADHD rating scale | Other | Age Matched Controls, Case / Retired NHL Players |
| Depression ScaleBecks Depression Inventory and Patient Health Questionnaire 9 (PHQ-9) | Other | Age Matched Controls, Case / Retired NHL Players |
| Cognitive AssessmentMontreal Cognitive Assessment (MoCA) | Other | Age Matched Controls, Case / Retired NHL Players |
Primary outcome
Cognition assessed with the Montreal Cognitive Assessment Scale
Time frame: 10 minutes
Montreal Cognitive Assessment Scale
19 secondary outcomes
Beck's Depression Inventory
Time frame: 10 minutes
Adult Attention Deficit assessed with the Connors' Adult Attention Deficit Disorder Rating Scale
Time frame: 10 minutes
Proprioception/Postural Stability assessed with the Sensory Organization Test
Time frame: 15 minutes
Human Interleukin-6 (IL-6)
Time frame: 5 Minutes
Patient Health Questionnaire 9 (PHQ-9)
Time frame: 5 minutes
Interleukin 7 (IL-7)
Time frame: 5 minutes
Human 8-hydroxy-2' -deoxyguanosine (8-OHdG)
Time frame: 5 minutes
3-nitrotyrosine
Time frame: 5 minutes
8-iso-Prostaglandin F2a
Time frame: 5 minutes
Dityrosine
Time frame: 5 minutes
Apolipoprotein E-4
Time frame: 5 minutes
Complement Component 3 B (C3b)
Time frame: 5 minutes
MicroRNA miR132
Time frame: 5 minutes
MicroRNA miR183
Time frame: 5 minutes
S-100B Calcium binding protein
Time frame: 5 minutes
Brain derived neurotrophic factor (BDNF)
Time frame: 5 minutes
Amyloid beta 40
Time frame: 5 minutes
Total Tau Protein (tTAU)
Time frame: 5 minutes
Eco-Rna Species
Time frame: 5 minutes
Results and safety
The study was stopped early (reason given: Could not recruit enough subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
- Individual participant dataSharing planned: No. Participants data will not be shared with individuals
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Harper, MD study chair
NYIT-COM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Deficits and Proprioceptive Disorders, run by New York Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Could not recruit enough subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognition assessed with the Montreal Cognitive Assessment Scale (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017.