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

Study Overview

• Status: Completed
• Conditions: Normal Human Subjects

Detailed Description

See brief summary.

• Study Type: Observational
• Enrollment (Actual): 97

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92660
      • Amen Clinics, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Healthy brain subjects; The study seeks to recruit 100 normal, healthy brain subjects between ages 10 and 90 for SPECT brain imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hour assessment and data may be presented up to 10 years later as part of a normative database

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hour assessment and data may be presented up to 10 years later as part of a normative database

Collaborators and Investigators

• Sponsor: Amen Clinics, Inc.
• Investigators: Principal Investigator: Daniel G Amen, MD, Amen Clinics, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: September 15, 2010
• First Submitted That Met QC Criteria: September 15, 2010
• First Posted (Estimate): September 17, 2010

Study Record Updates

• Last Update Posted (Estimate): September 20, 2010
• Last Update Submitted That Met QC Criteria: September 17, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Imaging; SPECT; Healthy brain; regional cerebral blood flow
• Other Study ID Numbers: 20021714

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No