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Functional Magnetic Resonance Imaging (fMRI) for Healthy Subjects
Phase 4
Waitlist Available
Led By Anthony Hudetz, PhD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
American Society of Anesthesiologist physical status of 1 (ASA-1), Healthy, non-smoking, no or minimal alcohol use
Right-handed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 minutes
Awards & highlights
Study Summary
This study is evaluating whether general anesthetics may be able to be used to help individuals with brain injuries.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blood Oxygen Level Dependent (BOLD) Response to Sensory Stimuli During Sedation
Secondary outcome measures
Average Squeeze Pressure Over 60 Minutes
Side effects data
From 2018 Phase 4 trial • 95 Patients • NCT0104127418%
Weight increase
10%
Tachycardia
6%
Psychiatric Hospitalization
6%
Hypertension
6%
Loss of libido
4%
Concentration impaired
4%
Appetite increase
4%
Memory impaired
4%
Rash
4%
Restlessness
4%
Amenorrhea
2%
Appetite decrease
2%
Dizziness upon standing
2%
Cellulitis
2%
Akathisia
2%
Anorgasmia
2%
Apathy
2%
Sleep disturbed
2%
Blurred vision
2%
Hot flashes
2%
Medical Hospitalization
2%
Drug-related hospitalization
2%
Drooling
2%
Drug abuse
2%
Fatigue
2%
Hiccup
2%
Hit by a motorcycle
2%
Hurt when riding a bike
2%
Mental activity decreased
2%
Muscle twitch
2%
Sleeplessness
2%
Pneumonia
2%
Nightmares
2%
Teeth grating
2%
Incarceration
2%
Sensory hallucinations
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Citalopram
Trial Design
1Treatment groups
Experimental Treatment
Group I: Functional Magnetic Resonance ImagingExperimental Treatment1 Intervention
While music is played Noninvasive functional magnetic resonance (fMRI) imaging will be performed at the University of Michigan Health System, University Hospital, Department of Radiology.
The fMRI is done under anesthesia using propofol. The researchers will manually control the infusion of propofol to achieve target effect-site concentrations of 1.2, 1.6, 2.0, and 2.4 μg/ml in a stepwise fashion.
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Who is running the clinical trial?
University of MichiganLead Sponsor
1,787 Previous Clinical Trials
6,365,487 Total Patients Enrolled
National Institute of General Medical Sciences (NIGMS)NIH
268 Previous Clinical Trials
248,827 Total Patients Enrolled
Anthony Hudetz, PhDPrincipal InvestigatorUniversity of Michigan
Frequently Asked Questions
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