Trial record 9 of 9 for:    HUPERZINE A

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amen Clinics, Inc.
ClinicalTrials.gov Identifier:
NCT01515839
First received: October 1, 2010
Last updated: January 23, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Traumatic Brain Injury
Dietary Supplement: Multivitamin Supplement intervention

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Brain Single Photon Emission Computed Tomography and Quantitative Electroencephalography In Former NFL Players: A Single-Site Exploratory Pilot Study

Resource links provided by NLM:


Further study details as provided by Amen Clinics, Inc.:

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. [ Time Frame: The SPECT scan is one day imaging exam. A follow up scan will be performed following a 2-12 month supplement intervention. ] [ Designated as safety issue: No ]
    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. [ Time Frame: The QEEG testing is one day exam. A follow up test will be performed following a 2-12 month supplement intervention. ] [ Designated as safety issue: No ]
    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.


Enrollment: 100
Study Start Date: May 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01515839

Locations
United States, California
Amen Clinics, Inc.
Newport Beach, California, United States, 92660
Sponsors and Collaborators
Amen Clinics, Inc.
Investigators
Principal Investigator: Daniel G Amen, MD Amen Clinics, Inc.
  More Information

Publications:
Responsible Party: Amen Clinics, Inc.
ClinicalTrials.gov Identifier: NCT01515839     History of Changes
Other Study ID Numbers: ISCAN 001
Study First Received: October 1, 2010
Last Updated: January 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Amen Clinics, Inc.:
SPECT
Imaging
Football
Traumatic brain injury
Regional cerebral blood flow

Additional relevant MeSH terms:
Huperzine A
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Vinpocetine
Acetylcarnitine
Thioctic Acid
Acetylcysteine
N-monoacetylcystine
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on April 16, 2014