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OpenTrials
Completed

NCT Number: NCT01203891

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

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Key information

Conditions

Normal Human Subjects

Age range

10 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Amen Clinics, Inc.

Newport Beach, California, 92660, United States

About this study

See brief summary.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • Suicidal thinking or behavior
  • Any psychiatric diagnosis assignable under contemporary DSM nosology
  • Unstable medical condition
  • epilepsy, serious head injury, or other significant neurological disorder or use of central nervous system medication.
  • Dementia, mental retardation, or coma
  • Substance abuse or alcoholism
  • Unreliability or inability to adhere to the requirements of the study
  • Inability to personally tolerate the requirements of the study
  • Significant exposure to occupational, diagnostic, or therapeutic radiation within the prior year
  • Pregnancy or breast-feeding
  • A first-degree relative meeting any of criteria 1 through 6.

Treatment and study plan

Primary outcomes

  1. Baseline SPECT image

    Time frame: 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 outcomes

  1. Concentration SPECT image

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Amen Clinics, Inc.

Industry

Registry information

Important dates

Study start
2003
Primary completion
2010
Study completion
2010
First posted
Sep 17, 2010
Registry last updated
Sep 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.