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Single Photon Emission Computed Tomography (SPECT) Imaging Study of Professional American Football Players

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ClinicalTrials.gov Identifier: NCT01515839
Recruitment Status : Completed
First Posted : January 24, 2012
Last Update Posted : January 24, 2012
Sponsor:
Information provided by (Responsible Party):

October 1, 2010
January 24, 2012
January 24, 2012
May 2009
June 2010   (Final data collection date for primary outcome measure)
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. ]
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.
Same as current
No Changes Posted
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. ]
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.
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Traumatic Brain Injury
Dietary Supplement: Multivitamin Supplement intervention

We recommend the following protocol:

  1. 2 tablets of a high quality multivitamin BID
  2. 2 capsules of omega 3 fish oil BID for a total of 3 grams daily
  3. 3 capsules of a brain and memory formula BID which contains Acetyl-L-Carnitine (HCL) 1000 mg, Ginkgo Biloba Extract 120 mg, Alpha-Lipoic Acid (ALA) 300 mg, Huperzine A (Huperzia serrata)150 mcg, N-Acetyl-L-Cysteine (NAC) 600mg, Phosphatidyl Serine (soy) 100 mg, Vinpocetine 15mg
  4. Weight loss
Other Names:
  • Omega 3 Fatty Acid
  • Acetyl-L-Carnitine (HCL)
  • Ginkgo Biloba Extract
  • Alpha-Lipoic Acid (ALA)
  • Huperzine A (Huperzia serrata)
  • N-Acetyl-L-Cysteine
  • Phosphatidyl Serine
  • Vinpocetine
Experimental: Supplement intervention
Dietary Supplement: Multivitamin, Omega 3 Supplement, Brain and Memory Formula
Intervention: Dietary Supplement: Multivitamin Supplement intervention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
June 2010
June 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01515839
ISCAN 001
Yes
Not Provided
Not Provided
Amen Clinics, Inc.
Amen Clinics, Inc.
Not Provided
Principal Investigator: Daniel G Amen, MD Amen Clinics, Inc.
Amen Clinics, Inc.
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP