- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01515839
Single Photon Emission Computed Tomography (SPECT) Imaging Study of Professional American Football Players
Brain Single Photon Emission Computed Tomography and Quantitative Electroencephalography In Former NFL Players: A Single-Site Exploratory Pilot Study
The investigators primary objective is to acquire preliminary data on one-hundred former NFL veterans with at least one full year of professional service using brain SPECT imaging in order to assess the degree to which NFL football puts players at risk for traumatic brain injury (TBI). TBI severity shall be gauged via visual inspection by a clinician trained in neuroanatomy, and also by a statistical comparison of subjects' brains to an in-house proprietary database comprised of the brains of healthy subjects.
The investigators secondary objective is to acquire additional data on these players such that investigators may establish causative factors and risks associated with said TBI.
The investigators tertiary objective is to acquire data on subjects using various mental health metrics in order to determine the effects of TBI.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Newport Beach, California, United States, 92660
- Amen Clinics, Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects must be at least 18 years of age
- Each subject must have been on an active NFL roster for a minimum of one year
Exclusion Criteria:
- Any subjects who could not cease taking psychoactive medications (recreational or otherwise) for an appropriate washout period prior to scanning were excluded from the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Supplement intervention
Dietary Supplement: Multivitamin, Omega 3 Supplement, Brain and Memory Formula
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We recommend the following protocol:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
A concentration SPECT scan will be given to assess the changes in regional cerebral blood flow to the brain in our study participants.
Time Frame: The SPECT scan is one day imaging exam. A follow up scan will be performed following a 2-12 month supplement intervention.
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For the concentration study the subject will start the Conner's Continuous Performance Task, a 15-minute computer-administered test of attention, subsequent to the accommodation period.
Three minutes into task performance 20 milliCuries of Tc-99m-hexamethylpropylene amine oxime will be injected through the catheter with attention to minimal disruption of the subject's attention task.
The subject will proceed to completion of the attention task.
The concentration scans will then be compared to a healthy brain subject normative database.
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The SPECT scan is one day imaging exam. A follow up scan will be performed following a 2-12 month supplement intervention.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantitative electroencephalography (QEEG) will be used to assess the damage to neural networks in our study participants.
Time Frame: The QEEG testing is one day exam. A follow up test will be performed following a 2-12 month supplement intervention.
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Subjects will undergo quantitative electroencephalography (QEEG) testing in both the eyes open and eyes closed condition to measure the electrical activity patterns of the brain.
Brain maps will be generated and compared against a normative database.
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The QEEG testing is one day exam. A follow up test will be performed following a 2-12 month supplement intervention.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel G Amen, MD, Amen Clinics, Inc.
Publications and helpful links
General Publications
- Amen DG, Newberg A, Thatcher R, Jin Y, Wu J, Keator D, Willeumier K. Impact of playing American professional football on long-term brain function. J Neuropsychiatry Clin Neurosci. 2011 Winter;23(1):98-106. doi: 10.1176/jnp.23.1.jnp98.
- Amen DG, Wu JC, Taylor D, Willeumier K. Reversing brain damage in former NFL players: implications for traumatic brain injury and substance abuse rehabilitation. J Psychoactive Drugs. 2011 Jan-Mar;43(1):1-5. doi: 10.1080/02791072.2011.566489.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Craniocerebral Trauma
- Trauma, Nervous System
- Brain Injuries
- Brain Injuries, Traumatic
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Anti-Infective Agents
- Cholinergic Agents
- Antiviral Agents
- Enzyme Inhibitors
- Neuroprotective Agents
- Protective Agents
- Micronutrients
- Respiratory System Agents
- Vitamins
- Antioxidants
- Vitamin B Complex
- Phosphodiesterase Inhibitors
- Free Radical Scavengers
- Nootropic Agents
- Expectorants
- Cholinesterase Inhibitors
- Vinpocetine
- Acetylcysteine
- Acetylcarnitine
- Thioctic Acid
- Huperzine A
Other Study ID Numbers
- ISCAN 001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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