Viewing Study NCT05756335


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Study NCT ID: NCT05756335
Status: UNKNOWN
Last Update Posted: 2023-03-06
First Post: 2023-02-15
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: The Brain Metabolism of Unpredictable Signals
Sponsor: Massachusetts General Hospital
Organization:

Study Overview

Official Title: Quantifying the Brain Metabolism Underlying Task-Based BOLD Imaging
Status: UNKNOWN
Status Verified Date: 2023-02
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.
Detailed Description: The proposed research consists of one experiment, combining positron emission tomography (PET) and magnetic resonance imaging (MRI) techniques to simultaneously estimate the cerebral metabolic rates of glucose (CMRglc) and oxygen (CMRO2), and their ratio (oxygen:glucose index; OGI). These outcome measures will be collected in the context of a behavioral intervention presenting subjects with predictable and unpredictable stimuli, and attended and unattended stimuli. Functional PET uses a slow infusion of 2-\[18F\]-fluro-deoxyglucose (FDG) to estimate regional CMRglc, measuring relative changes in radiotracer uptake between blocks of task and rest. Dual-calibrated fMRI uses a sequence of hyperoxic (increased O2) and hypercapnic (increased CO2) challenges, along with a specialized sequence of MRI scans (estimating cerebral blood flow and blood-oxygen level-dependent signal) to estimate absolute CMRO2.

All subjects will be scanned, and each will complete the same behavioral intervention. First, the investigators will aim to assess the reliability of this hybrid imaging technique by having subjects complete two identical scan sessions. Second, the investigators will deliver a behavioral intervention to test the relationship between stimuli predictability, CMRglc, CMRO2, and OGI.

This experimental design is capable of producing effects observable in single subjects, and prior studies using fPET and dual-calibrated fMRI have produced effect sizes that our sample size is more than adequate to detect.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: