Normal Human SubjectsNCT01203891
Single Photon Emission Computed Tomography of the Normal Human Brain
An observational study of Normal Human Subjects, run by Amen Clinics, Inc. at 1 site in United States.
Trial summary
The objective of the study is to acquire a database of Single Photon Emission Computed Tomographic (SPECT) studies of the brains of normal human subjects in resting and concentrating states. Read more about this study
- Who is it for?
- Ages 10 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Human Subjects
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to May 2010
- Phase
- Observational
- 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 10 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study seeks to recruit 100 subjects between ages 10 and 90 for SPECT brain imaging.
Who may be able to join
- The study seeks to recruit 100 normal human subjects between ages 10 and 90 for SPECT brain imaging. Subjects will initially be screened for psychiatric and other major illnesses with a screening questionnaire; they will also be given a standard DSM-4 computer-administered questionnaire (The DISC for children and teens and the SCID for adults). They will also meet individually with a psychiatrist or psychological assistant for a screening interview.
Who cannot join
- Suicidal thinking or behavior
- Any psychiatric diagnosis assignable under contemporary DSM nosology
- Unstable medical condition
- epilepsy, serious head injury, or other significant neurological disorder or use of central nervous system medication.
- Dementia, mental retardation, or coma
- Substance abuse or alcoholism
Show all 11Show fewer
- Unreliability or inability to adhere to the requirements of the study
- Inability to personally tolerate the requirements of the study
- Significant exposure to occupational, diagnostic, or therapeutic radiation within the prior year
- Pregnancy or breast-feeding
- A first-degree relative meeting any of criteria 1 through 6.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the study is to acquire a database of Single Photon Emission Computed Tomographic (SPECT) studies of the brains of normal human subjects in resting and concentrating states. The database will provide a basis for subsequent investigation of meaningful brain differences between clinical and normal subject groups
Read the detailed description
See brief summary.
- Conditions
- Normal Human Subjects
- Keywords
- SPECT, Imaging, Healthy brain, regional cerebral blood flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy brain subjects | The study seeks to recruit 100 normal, healthy brain subjects between ages 10 and 90 for SPECT brain imaging. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline SPECT image
For the baseline resting study with adult subjects approximately 20 milliCuries of Tc-99m-hexamethylpropylene amine oxime (HMPAO, commercially marketed by Amersham Pharmaceuticals under the trade name Ceretec) will be injected after the initial equilibration period. Ceretec is an FDA-approved functional brain imaging radiopharmaceutical currently widely commercially available.
Measured: 24 hour assessment and data may be presented up to 10 years later as part of a normative database
Secondary outcomes (1)
Concentration SPECT image
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 HMPAO 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.
Measured: 24 hour assessment and data may be presented up to 10 years later as part of a normative database
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startJan 2003
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Human SubjectsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amen Clinics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Daniel G Amen, MD, Principal investigator, Amen Clinics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203891
- Sponsor's protocol ID
- 20021714
- Status last verified
- Sep 2010
- First submitted
- 15 Sep 2010
- Last updated
- 20 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Photon Emission Computed Tomography of the Normal Human Brain
- ClinicalTrials.gov ID
- NCT01203891
- Acronym / sponsor ID
- 20021714
- Conditions
- Normal Human Subjects
- Keywords
- SPECT, Imaging, Healthy brain, regional cerebral blood flow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Amen Clinics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 17 Sep 2010 (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 objective of the study is to acquire a database of Single Photon Emission Computed Tomographic (SPECT) studies of the brains of normal human subjects in resting and concentrating states. The database will provide a basis for subsequent investigation of meaningful brain differences between clinical and normal subject groups
Detailed description
See brief summary.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy brain subjects | – | –The study seeks to recruit 100 normal, healthy brain subjects between ages 10 and 90 for SPECT brain imaging. |
Who may qualify
- Ages
- 10 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study seeks to recruit 100 subjects between ages 10 and 90 for SPECT brain imaging.
Key inclusion criteria (1 listed)
- The study seeks to recruit 100 normal human subjects between ages 10 and 90 for SPECT brain imaging. Subjects will initially be screened for psychiatric and other major illnesses with a screening questionnaire; they will also be given a standard DSM-4 computer-administered questionnaire (The DISC for children and teens and the SCID for adults). They will also meet individually with a psychiatrist or psychological assistant for a screening interview.
Key exclusion criteria (11 listed)
- Suicidal thinking or behavior
- Any psychiatric diagnosis assignable under contemporary DSM nosology
- Unstable medical condition
- epilepsy, serious head injury, or other significant neurological disorder or use of central nervous system medication.
- Dementia, mental retardation, or coma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Baseline SPECT image
Time frame: 24 hour assessment and data may be presented up to 10 years later as part of a normative database
For the baseline resting study with adult subjects approximately 20 milliCuries of Tc-99m-hexamethylpropylene amine oxime (HMPAO, commercially marketed by Amersham Pharmaceuticals under the trade name Ceretec) will be injected after the initial equilibration period. Ceretec is an FDA-approved functional brain imaging radiopharmaceutical currently widely commercially available.
1 secondary outcome
Concentration SPECT image
Time frame: 24 hour assessment and data may be presented up to 10 years later as part of a normative database
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 20 Sep 2010.
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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?
An observational study of Normal Human Subjects, 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 1 inclusion and 11 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 20 Sep 2010. 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?
Baseline SPECT image (time frame: 24 hour assessment and data may be presented up to 10 years later as part of a normative database). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2010.