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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
History of Changes
  Purpose

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


Condition
Normal Human Subjects

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Single Photon Emission Computed Tomography of the Normal Human Brain

Resource links provided by NLM:

MedlinePlus related topics: CT Scans
U.S. FDA Resources

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

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 97
Study Start Date: January 2003
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy brain subjects
The study seeks to recruit 100 normal, healthy brain subjects between ages 10 and 90 for SPECT brain imaging.

Detailed Description:

See brief summary.

  Eligibility

Ages Eligible for Study:   10 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01203891

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

No publications provided

Responsible Party: Dr. Daniel Amen, Amen Clinics, Inc.
ClinicalTrials.gov Identifier: NCT01203891     History of Changes
Other Study ID Numbers: 20021714
Study First Received: September 15, 2010
Last Updated: September 17, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Amen Clinics, Inc.:
SPECT
Imaging
Healthy brain
regional cerebral blood flow

ClinicalTrials.gov processed this record on June 18, 2013