Overview

This trial is active, not recruiting.

Condition healthy
Treatments thiopental, propofol
Phase phase 4
Sponsor Weill Medical College of Cornell University
Collaborator National Institutes of Health (NIH)
Start date March 2007
End date December 2015
Trial size 90 participants
Trial identifier NCT00504894, 0701008933, K08GM083213

Summary

This study involves 90 healthy volunteers aged between 18 and 50 recruited from the general community. It involves doing a set of simple memory tests while inside a fMRI machine. The subject is given a very low dose of an anesthetic drug intravenously while in the scanner. The subject then sees a sequence of pictures on a screen, and presses a button if they remember seeing the picture before. While this is happening, the scanner will be capturing images that tell us what parts of the brain are active. Hypothesis: patterns of hippocampal and amygdala activation during the encoding and retrieval of memory,as measured by fMRI, will be altered by intravenous anesthetics such that suppression of hippocampal and amygdala activities will be dissociable. This dissociation pattern will be different between the drugs propofol and thiopental

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Arm
(Placebo Comparator)
Drug given in low dose to gauge subject's responses to visual stimuli.
thiopental
A low dose given intravenously one time for just under an hour while the subject is shown visually stimulating images in an MRI machine.
(Placebo Comparator)
Thiopental administration
propofol
A low dose given intravenously while the subject is shown visually stimulating images in an MRI machine.

Primary Outcomes

Measure
Performance on memory tasks
time frame: 2 hours after MRI

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

Inclusion Criteria: - age b/w 18 and 50 - right-handed - minimum of high school education - fluent in English - normal vocabulary Exclusion Criteria: - any significant medical/psychiatric comorbidity - deficit in vision or hearing that would impede the study - allergies to any of the study drugs, to soybeans, or eggs. - history of head trauma - family history of major psychiatric illness - body mass index > 30 kg/m2 - claustrophobia - prior exposure to IAPS pictures - pregnancy - permanent metal objects anywhere in the body - a personal/family history of any porphyria

Additional Information

Official title Neuroimaging the Effects of Intravenous Anesthetic on Amygdala Dependent Memory Processes
Principal investigator Kane Pryor, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Weill Medical College of Cornell University.