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

NCT01515839 | Completed DMC

• 1 other identifier: ISCAN 001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury

Keywords

SPECT; Imaging; Football; Traumatic brain injury; Regional cerebral blood flow

Outcome Measures

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.

  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.

  The SPECT scan is one day imaging exam. A follow up scan will be performed following a 2-12 month supplement intervention.

Secondary Outcomes (1)

• Quantitative electroencephalography (QEEG) will be used to assess the damage to neural networks in our study participants.

  The QEEG testing is one day exam. A follow up test will be performed following a 2-12 month supplement intervention.

Study Arms (1)

Supplement intervention

EXPERIMENTAL

Dietary Supplement: Multivitamin, Omega 3 Supplement, Brain and Memory Formula

Dietary Supplement: Multivitamin Supplement intervention

Interventions

Multivitamin Supplement intervention DIETARY_SUPPLEMENT

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

Also known as: 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

Supplement intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amen Clinics, Inc.: lead

Study Sites (1)

Amen Clinics, Inc.

Newport Beach, California, 92660, United States

Location

Related Publications (2)

• 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.

  PMID: 21304145 RESULT

• 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.

  PMID: 21615001 RESULT

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Fatty Acids, Omega-3; Acetylcarnitine; Ginkgo biloba extract; Thioctic Acid; huperzine A; Acetylcysteine; Phosphatidylserines; vinpocetine

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Carnitine; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Carboxylic Acids; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Cysteine; Amino Acids, Sulfur; Amino Acids; Amino Acids, Peptides, and Proteins; Glycerophospholipids; Phosphatidic Acids; Glycerophosphates; Phospholipids; Membrane Lipids

Study Officials

• Daniel G Amen, MD

  Amen Clinics, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2010
• First Posted: January 24, 2012
• Study Start: May 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: January 24, 2012

Record last verified: 2012-01

Locations

US (1)