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

A

Amen Clinics, Inc.

Status

Completed

Conditions

Traumatic Brain Injury

Treatments

Dietary Supplement: Multivitamin Supplement intervention

Study type

Interventional

Funder types

Industry

Identifiers

NCT01515839
ISCAN 001

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Supplement intervention
Experimental group
Description:
Dietary Supplement: Multivitamin, Omega 3 Supplement, Brain and Memory Formula
Treatment:
Dietary Supplement: Multivitamin Supplement intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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