Status:

UNKNOWN

Neurochemical Mechanisms of the Awake vs. Anesthetized Brain

Lead Sponsor:

Massachusetts General Hospital

Collaborating Sponsors:

Boston University

Conditions:

Anesthesia

Healthy

Eligibility:

All Genders

18-45 years

Phase:

EARLY_PHASE1

Brief Summary

The investigators will be studying the sedative drug dexmedetomidine using hybrid PET/fMRI/EEG imaging to better understand the neuropharmacology of anesthesia/artificially induced sleep.

Detailed Description

A group of healthy volunteers will undergo simultaneous PET/fMRI/EEG imaging under two different conditions: while being administered a sedative (dexmedetomidine), and while being administered a norma...

Eligibility Criteria

Inclusion

  • Adults aged 18-45.
  • No contraindications to MRI or PET scanning.

Exclusion

  • Contraindications to fMRI scanning and PET scanning (including presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia);
  • Pregnancy or breast feeding;
  • Current or past history of major medical, neurological, or psychiatric condition;
  • History of major head trauma;
  • Any cardiovascular disorders, including heart disorders or high blood pressure \[\>155/95\];
  • Breathing problems such as severe asthma;
  • Bleeding disorder, or use of anticoagulants;
  • Bladder obstruction, urinary problems, or history of impaired elimination;
  • Known kidney or liver problems;
  • Intestinal blockage;
  • Raynaud syndrome
  • Peripheral nerve injury;
  • Diabetes;
  • Glaucoma;
  • Sleep disorder, such as sleep apnea, insomnia, or narcolepsy
  • Current use of any drugs that affect sleep
  • Current or recent use of medications (neurological or psychiatric) affecting brain function
  • Current or past history of chronic pain (assessed at discretion of PI);
  • History of allergic reactions
  • History of chronic obstructive pulmonary diseases
  • Ulcerative skin conditions or other dermatologic conditions which could interfere with blood pressure cuff placement
  • Body mass index above 30
  • Current smoker
  • Lack of current health insurance coverage
  • Employed under the direct supervision of the investigators conducting the research
  • Hair in dreadlocks, twists, or braids that cannot be removed
  • Eczema on the scalp or face

Key Trial Info

Start Date :

April 12 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 1 2023

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT05435560

Start Date

April 12 2022

End Date

April 1 2023

Last Update

June 28 2022

Active Locations (1)

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1

Athinoula A. Martinos Center for Biomedical Imaging

Charlestown, Massachusetts, United States, 02129