Single Photon Emission Computed Tomography of the Normal Human Brain

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01203891

Enrollment

Registered

2010-09-17

Start date

2003-01-31

Completion date

2010-05-31

Last updated

2010-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Human Subjects

Keywords

SPECT, Imaging, Healthy brain, regional cerebral blood flow

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

10 Years to 90 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results