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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01515839
Enrollment
100
Registered
2012-01-24
Start date
2009-05-31
Completion date
2010-06-30
Last updated
2012-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

SPECT, Imaging, Football, Traumatic brain injury, Regional cerebral blood flow

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.

Interventions

DIETARY_SUPPLEMENTMultivitamin 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

Sponsors

Amen Clinics, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026