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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01515839
• Other study ID #: ISCAN 001
• Status: Completed
• Phase: N/A
• First received: October 1, 2010
• Last updated: January 23, 2012
• Start date: May 2009
• Est. completion date: June 2010

Study information

• Verified date: January 2012
• Source: Amen Clinics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

Dietary Supplement:
• Multivitamin Supplement intervention
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

Locations

Country	Name	City	State
United States	Amen Clinics, Inc.	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Amen Clinics, Inc.

Country where clinical trial is conducted

United States, 

References & 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/appi.neuropsych.23.1.98. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Quantitative electroencephalography (QEEG) will be used to assess the damage to neural networks in our study participants.	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.	The QEEG testing is one day exam. A follow up test will be performed following a 2-12 month supplement intervention.	No