NCT05756335

Brief Summary

The investigators will be studying brain glucose and oxygen metabolism using hybrid PET/fMRI imaging to better understand how decoupling between brain glucose and oxygen metabolism relates to the processing of unpredictable sensory signals.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

March 6, 2023

Status Verified

February 1, 2023

Enrollment Period

12 months

First QC Date

February 15, 2023

Last Update Submit

February 23, 2023

Conditions

Healthy

Keywords

Brain metabolismPositron Emission TomographyMagnetic Resonance Imaging

Outcome Measures

Primary Outcomes (3)

  • Brain positron emission tomography (PET) imaging signals

    Changes in glucose metabolism will be quantified from brain PET images

    after PET image analysis and with study completion, an average of 1 year

  • Functional magnetic resonance imaging (fMRI) signals

    Changes in oxygen metabolism will be quantified from dual-calibrated fMRI

    after fMRI image analysis and with study completion, an average of 1 year

  • Oxygen-glucose index

    Ratio of cerebral metabolic rates of glucose and oxygen from PET and fMRI signals

    after PET/fMRI image analysis and with study completion, an average of 1 year

Study Arms (1)

Behavioral intervention

EXPERIMENTAL

Subjects are presented with a simultaneous sequence of faces and spoken words. Face stimuli include a representative sample of realistic faces across a range of ages. Spoken word stimuli are simple nouns spoken by a single female speaker.

Behavioral: (Un)predictable and (un)attended stimuli

Interventions

(Un)predictable and (un)attended stimuliBEHAVIORAL

Subjects will complete four task conditions in each scan session: (1) Visual Unpredictable, (2) Visual Predictable, (3) Auditory Unpredictable, and (4) Auditory Predictable. In visual and auditory conditions subjects attend to visual or auditory stimuli and ignore the other domain, pressing a button when they detect an infrequently occurring stimulus inversion in the target domain. In unpredictable and predictable conditions, the attended domain either presents random (unpredictable) stimuli, or the same face or word stimuli repeated (predictable).

Behavioral intervention

Eligibility Criteria

Age21 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged 21-35.
  • No contraindications to MRI or PET scanning.
  • Right-handed.
  • Fluent to speak, read, and understand English.

You may not qualify if:

  • Adults unable to consent
  • Contraindications to fMRI scanning and PET scanning (including the 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)
  • Inability to lie motionless in the scanner
  • Pregnancy, seeking or suspecting pregnancy, or breastfeeding
  • History of major head trauma
  • Intracranial lesion
  • Cardiovascular disorders, including heart disorders or high blood pressure \[\>155/95\]
  • Breathing problems such as severe asthma, emphysema, or pulmonary disease
  • Bleeding disorder, or use of anticoagulants
  • Bladder obstruction, urinary problems, or history of impaired elimination
  • Known kidney or liver problems
  • Past severe COVID-19 infection
  • Intestinal blockage
  • Raynaud syndrome
  • Anemia
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Athinoula A. Martinos Center for Biomedical Imaging

Charlestown, Massachusetts, 02129, United States

Location

Study Officials

  • Christin Y Sander, PhD

    Athinoula A. Martinos Center for Biomedical Imaging

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Irena Bass

CONTACT

6177269034ibass@mgh.harvard.edu

Christin Y Sander, PhD

CONTACT

6177269034csander@mgh.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 15, 2023

First Posted

March 6, 2023

Study Start

March 1, 2023

Primary Completion

February 28, 2024

Study Completion

February 28, 2025

Last Updated

March 6, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)