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

NCT ID: NCT01515839

Last Updated: 2012-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-06-30

Brief Summary

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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

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Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Supplement intervention

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

Group Type EXPERIMENTAL

Multivitamin Supplement intervention

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Amen Clinics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel G Amen, MD

Role: PRINCIPAL_INVESTIGATOR

Amen Clinics, Inc.

Locations

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Amen Clinics, Inc.

Newport Beach, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 21304145 (View on PubMed)

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.

Reference Type RESULT
PMID: 21615001 (View on PubMed)

Other Identifiers

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ISCAN 001

Identifier Type: -

Identifier Source: org_study_id

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