Single Photon Emission Computed Tomography of the Normal Human Brain

Completed

• Conditions: Normal Human Subjects

• Registration Number: NCT01203891
• Lead Sponsor: Amen Clinics, Inc.

Brief 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. 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 Timeline

• Study Start: 2003-01
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2010-09
• Study First Submitted: 2010-09-15
• Study First Submitted QC: 2010-09-15
• Study First Posted: 2010-09-17
• Last Update Submitted: 2010-09-17
• Last Update Posted: 2010-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Baseline SPECT image	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.

Secondary Outcome Measures

Name	Time	Method
Concentration SPECT image	24 hour assessment and data may be presented up to 10 years later as part of a normative database	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.

Trial Locations

Locations (1)

Amen Clinics, Inc.; 🇺🇸 Newport Beach, California, United States