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

Not Applicable

Completed

• Conditions: Traumatic Brain Injury

• Registration Number: NCT01515839
• Lead Sponsor: Amen Clinics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Study First Submitted: 2010-10-01
• Status Verified: 2012-01
• Study First Submitted QC: 2012-01-23
• Last Update Submitted: 2012-01-23
• Study First Posted: 2012-01-24
• Last Update Posted: 2012-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
A concentration SPECT scan will be given to assess the changes in regional cerebral blood flow to the brain in our study participants.	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 Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (1)

Amen Clinics, Inc.; 🇺🇸 Newport Beach, California, United States