Single Photon Emission Computed Tomography (SPECT) Imaging Study of Professional American Football Players
|ClinicalTrials.gov Identifier: NCT01515839|
Recruitment Status : Completed
First Posted : January 24, 2012
Last Update Posted : January 24, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Dietary Supplement: Multivitamin Supplement intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Brain Single Photon Emission Computed Tomography and Quantitative Electroencephalography In Former NFL Players: A Single-Site Exploratory Pilot Study|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
Experimental: Supplement intervention
Dietary Supplement: Multivitamin, Omega 3 Supplement, Brain and Memory Formula
Dietary Supplement: Multivitamin Supplement intervention
We recommend the following protocol:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01515839
|United States, California|
|Amen Clinics, Inc.|
|Newport Beach, California, United States, 92660|
|Principal Investigator:||Daniel G Amen, MD||Amen Clinics, Inc.|