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

January 23, 2012 updated by: Amen Clinics, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Newport Beach, California, United States, 92660
        • Amen Clinics, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supplement intervention
Dietary Supplement: Multivitamin, Omega 3 Supplement, Brain and Memory Formula
Dietary supplement: Multivitamin Supplement intervention

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
Other Names:
  • 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amen Clinics, Inc.

Investigators

  • Principal Investigator: Daniel G Amen, MD, Amen Clinics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

October 1, 2010

First Submitted That Met QC Criteria

January 23, 2012

First Posted (Estimate)

January 24, 2012

Study Record Updates

Last Update Posted (Estimate)

January 24, 2012

Last Update Submitted That Met QC Criteria

January 23, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISCAN 001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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