Single Photon Emission Computed Tomography (SPECT) Imaging Study of Professional American Football Players
This study has been completed.
Sponsor:
Amen Clinics, Inc.
Information provided by (Responsible Party):
Amen Clinics, Inc.
ClinicalTrials.gov Identifier:
NCT01515839
First received: October 1, 2010
Last updated: January 23, 2012
Last verified: January 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Traumatic Brain Injury |
Dietary Supplement: Multivitamin Supplement intervention |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Brain Single Photon Emission Computed Tomography and Quantitative Electroencephalography In Former NFL Players: A Single-Site Exploratory Pilot Study |
Resource links provided by NLM:
Drug Information available for:
Cysteine
Serine
Carnitine
Acetylcysteine
Thioctic Acid
Acetyl-L-carnitine
Vinpocetine
Ginkgo biloba
Omega-3 Fatty Acids
U.S. FDA Resources
Further study details as provided by Amen Clinics, Inc.:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]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.
| Enrollment: | 100 |
| Study Start Date: | May 2009 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Supplement intervention
Dietary Supplement: Multivitamin, Omega 3 Supplement, Brain and Memory Formula
|
Dietary Supplement: Multivitamin Supplement intervention
We recommend the following protocol:
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01515839
Locations
| United States, California | |
| Amen Clinics, Inc. | |
| Newport Beach, California, United States, 92660 | |
Sponsors and Collaborators
Amen Clinics, Inc.
Investigators
| Principal Investigator: | Daniel G Amen, MD | Amen Clinics, Inc. |
More Information
Publications:
| Responsible Party: | Amen Clinics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01515839 History of Changes |
| Other Study ID Numbers: | ISCAN 001 |
| Study First Received: | October 1, 2010 |
| Last Updated: | January 23, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Amen Clinics, Inc.:
|
SPECT Imaging Football Traumatic brain injury Regional cerebral blood flow |
Additional relevant MeSH terms:
|
Brain Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Vinpocetine Acetylcarnitine Thioctic Acid Huperzine A Acetylcysteine N-monoacetylcystine Nootropic Agents Central Nervous System Agents |
Therapeutic Uses Pharmacologic Actions Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Antiviral Agents Anti-Infective Agents Expectorants Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on May 23, 2013