Single Photon Emission Computed Tomography (SPECT) Imaging Study of Professional American Football Players
This study has been completed.
Sponsor:
Amen Clinics, Inc.
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
| Tracking Information | |||||
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| First Received Date ICMJE | October 1, 2010 | ||||
| Last Updated Date | January 23, 2012 | ||||
| Start Date ICMJE | May 2009 | ||||
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01515839 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Single Photon Emission Computed Tomography (SPECT) Imaging Study of Professional American Football Players | ||||
| Official Title ICMJE | Brain Single Photon Emission Computed Tomography and Quantitative Electroencephalography In Former NFL Players: A Single-Site Exploratory Pilot Study | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Traumatic Brain Injury | ||||
| Intervention ICMJE | Dietary Supplement: Multivitamin Supplement intervention
We recommend the following protocol:
Other Names:
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| Study Arm (s) | Experimental: Supplement intervention
Dietary Supplement: Multivitamin, Omega 3 Supplement, Brain and Memory Formula
Intervention: Dietary Supplement: Multivitamin Supplement intervention |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 100 | ||||
| Completion Date | June 2010 | ||||
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01515839 | ||||
| Other Study ID Numbers ICMJE | ISCAN 001 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Amen Clinics, Inc. | ||||
| Study Sponsor ICMJE | Amen Clinics, Inc. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Amen Clinics, Inc. | ||||
| Verification Date | January 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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