Traumatic Brain InjuryNCT01515839
Single Photon Emission Computed Tomography (SPECT) Imaging Study of Professional American Football Players
A study testing Multivitamin Supplement intervention in people with Traumatic Brain Injury, run by Amen Clinics, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Multivitamin Supplement intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Brain Single Photon Emission Computed Tomography and Quantitative Electroencephalography In Former NFL Players: A Single-Site Exploratory Pilot Study
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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Multivitamin Supplement intervention
- Keywords
- SPECT, Imaging, Football, Traumatic brain injury, Regional cerebral blood flow
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multivitamin Supplement interventionDietary supplement
Also called Omega 3 Fatty Acid, Acetyl-L-Carnitine (HCL), Ginkgo Biloba Extract, Alpha-Lipoic Acid (ALA)
We recommend the following protocol:
- 2 tablets of a high quality multivitamin BID
- 2 capsules of omega 3 fish oil BID for a total of 3 grams daily
- 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
- Weight loss
| Study group | Role | What they receive |
|---|---|---|
| Supplement intervention | Experimental | Dietary Supplement: Multivitamin, Omega 3 Supplement, Brain and Memory Formula Receives: Dietary Supplement: Multivitamin Supplement intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
A concentration SPECT scan will be given to assess the changes in regional cerebral blood flow to the brain in our study participants.
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.
Measured: The SPECT scan is one day imaging exam. A follow up scan will be performed following a 2-12 month supplement intervention.
Secondary outcomes (1)
Quantitative electroencephalography (QEEG) will be used to assess the damage to neural networks in our study participants.
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.
Measured: The QEEG testing is one day exam. A follow up test will be performed following a 2-12 month supplement intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startMay 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amen Clinics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel G Amen, MD, Principal investigator, Amen Clinics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01515839
- Sponsor's protocol ID
- ISCAN 001
- Status last verified
- Jan 2012
- First submitted
- 1 Oct 2010
- Last updated
- 24 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21304145Amen 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.
PubMed 21615001
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Single Photon Emission Computed Tomography and Quantitative Electroencephalography In Former NFL Players: A Single-Site Exploratory Pilot Study
- ClinicalTrials.gov ID
- NCT01515839
- Acronym / sponsor ID
- ISCAN 001
- Conditions
- Traumatic Brain Injury
- Keywords
- SPECT, Imaging, Football, Traumatic brain injury, Regional cerebral blood flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Amen Clinics, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 24 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supplement intervention | Experimental | Dietary Supplement: Multivitamin Supplement interventionDietary Supplement: Multivitamin, Omega 3 Supplement, Brain and Memory Formula |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multivitamin Supplement interventionAlso: Omega 3 Fatty Acid, Acetyl-L-Carnitine (HCL), Ginkgo Biloba Extract, Alpha-Lipoic Acid (ALA)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 | Dietary supplement | Supplement intervention |
Primary outcome
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.
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2012.
- Results publication: PubMed 21304145Amen 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.
- Results publication: PubMed 21615001Amen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel G Amen, MD principal investigator
Amen Clinics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multivitamin Supplement intervention in people with Traumatic Brain Injury, run by Amen Clinics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01515839, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2012.