Clinical trial NCT01515839: Single Photon Emission Computed Tomography (SPECT) Imaging Study of Professional American Football Players
Official title: Brain Single Photon Emission Computed Tomography and Quantitative Electroencephalography In Former NFL Players: A Single-Site Exploratory Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: SPECT
Imaging
Football
Traumatic brain injury
Regional cerebral blood flow
Lead sponsor: Amen Clinics, Inc.
Sponsor class: INDUSTRY
First posted: 2012-01-24
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: A concentration SPECT scan will be given to assess the changes in regional cerebral blood flow to the brain in our study participants.
timeFrame: The SPECT scan is one day imaging exam. A follow up scan will be performed following a 2-12 month supplement intervention.
Secondary outcomes:
measure: Quantitative electroencephalography (QEEG) will be used to assess the damage to neural networks in our study participants.
timeFrame: The QEEG testing is one day exam. A follow up test will be performed following a 2-12 month supplement intervention.
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Amen Clinics, Inc.
state: California
Study officials:
affiliation: Amen Clinics, Inc.
name: Daniel G Amen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.