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Completed

NCT Number: NCT01515839

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

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Amen Clinics, Inc.

Newport Beach, California, 92660, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multivitamin Supplement intervention

Dietary Supplement

We recommend the following protocol:

  • 2 tablets of a high quality multivitamin BID
  • 2 capsules of omega 3 fish oil BID for a total of 3 grams daily
  • 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
  • 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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Amen Clinics, Inc.

Industry

Registry information

Official study title

Brain Single Photon Emission Computed Tomography and Quantitative Electroencephalography In Former NFL Players: A Single-Site Exploratory Pilot Study

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 24, 2012
Registry last updated
Jan 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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