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

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multivitamin Supplement intervention
Sponsored by
Amen Clinics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring SPECT, Imaging, Football, Traumatic brain injury, Regional cerebral blood flow

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Amen Clinics, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supplement intervention

Arm Description

Dietary Supplement: Multivitamin, Omega 3 Supplement, Brain and Memory Formula

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 1, 2010
Last Updated
January 23, 2012
Sponsor
Amen Clinics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01515839
Brief Title
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

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amen Clinics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
SPECT, Imaging, Football, Traumatic brain injury, Regional cerebral blood flow

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supplement intervention
Arm Type
Experimental
Arm Description
Dietary Supplement: Multivitamin, Omega 3 Supplement, Brain and Memory Formula
Intervention Type
Dietary Supplement
Intervention Name(s)
Multivitamin Supplement intervention
Other Intervention Name(s)
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
Intervention Description
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
Primary Outcome Measure Information:
Title
A concentration SPECT scan will be given to assess the changes in regional cerebral blood flow to the brain in our study participants.
Description
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.
Time Frame
The SPECT scan is one day imaging exam. A follow up scan will be performed following a 2-12 month supplement intervention.
Secondary Outcome Measure Information:
Title
Quantitative electroencephalography (QEEG) will be used to assess the damage to neural networks in our study participants.
Description
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.
Time Frame
The QEEG testing is one day exam. A follow up test will be performed following a 2-12 month supplement intervention.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel G Amen, MD
Organizational Affiliation
Amen Clinics, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amen Clinics, Inc.
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21304145
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.
Results Reference
result
PubMed Identifier
21615001
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.
Results Reference
result

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

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