Single Photon Emission Computed Tomography of the Normal Human Brain

This study has been completed.
Sponsor:
Information provided by:
Amen Clinics, Inc.
ClinicalTrials.gov Identifier:
NCT01203891
First received: September 15, 2010
Last updated: September 17, 2010
Last verified: September 2010

September 15, 2010
September 17, 2010
January 2003
May 2010   (final data collection date for 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 ] [ Designated as safety issue: No ]
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.
Baseline SPECT image [ Time Frame: One day ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01203891 on ClinicalTrials.gov Archive Site
Concentration SPECT image [ Time Frame: 24 hour assessment and data may be presented up to 10 years later as part of a normative database ] [ 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 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.
Concentration SPECT image [ Time Frame: One day ] [ 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 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.
Not Provided
Not Provided
 
Single Photon Emission Computed Tomography of the Normal Human Brain
Single Photon Emission Computed Tomography of the Normal Human Brain

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

See brief summary.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

The study seeks to recruit 100 subjects between ages 10 and 90 for SPECT brain imaging.

Normal Human Subjects
Not Provided
Healthy brain subjects
The study seeks to recruit 100 normal, healthy brain subjects between ages 10 and 90 for SPECT brain imaging.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
97
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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.

Exclusion Criteria:

  1. Suicidal thinking or behavior
  2. Any psychiatric diagnosis assignable under contemporary DSM nosology
  3. Unstable medical condition
  4. epilepsy, serious head injury, or other significant neurological disorder or use of central nervous system medication.
  5. Dementia, mental retardation, or coma
  6. Substance abuse or alcoholism
  7. Unreliability or inability to adhere to the requirements of the study
  8. Inability to personally tolerate the requirements of the study
  9. Significant exposure to occupational, diagnostic, or therapeutic radiation within the prior year
  10. Pregnancy or breast-feeding
  11. A first-degree relative meeting any of criteria 1 through 6.
Both
10 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01203891
20021714
Yes
Dr. Daniel Amen, Amen Clinics, Inc.
Amen Clinics, Inc.
Not Provided
Principal Investigator: Daniel G Amen, MD Amen Clinics, Inc.
Amen Clinics, Inc.
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP