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Clinical Trials/NCT05523817
NCT05523817
Recruiting
N/A

Probing the Functional and Behavioral Impact of Precision Circuit Modulation in Neuropsychiatric Diseases

Massachusetts General Hospital1 site in 1 country80 target enrollmentMarch 12, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Major Depressive Disorder
Sponsor
Massachusetts General Hospital
Enrollment
80
Locations
1
Primary Endpoint
Blood oxygenation level dependent (BOLD) activation
Status
Recruiting
Last Updated
7 months ago

Overview

Brief Summary

Repetitive transcranial magnetic stimulation (rTMS) is a way of non-invasively stimulating specific brain networks and is an established treatment for Major Depressive Disorder (MDD). This proposal will reveal network mechanisms of the therapeutic effects of rTMS by investigating how stimulating each network specifically changes network connectivity and behavior. This will be done in a highly individualized manner in depressed and healthy patients, leading to more effective and more individualized treatments for depression.

Detailed Description

Network models are increasingly invoked to characterize the neurobiological underpinnings of mental illnesses. Dysfunction within specific circuits promotes the formation of specific symptoms. This suggests an opportunity to treat specific symptoms by modulating specific circuits. Repetitive transcranial magnetic stimulation (rTMS) is capable of circuit-specific neuromodulation. It is also an established treatment for Major Depressive Disorder (MDD). Clinical experience suggests that rTMS treats different symptom constructs by stimulating different circuits. However, there remains a critical lack of mechanistic evidence to support putative network mechanisms of rTMS, limiting its ability to treat patients with more personalized and optimized approaches. This mechanistic proposal will first use resting-state functional connectivity (FC) MRI and customized analytic pipelines to characterize functional network topography in healthy and depressed individuals at high resolution.This data will be used to derive rTMS targets functionally situated in discrete prefrontal networks (e.g., control, default, salience, limbic/reward). Next, patients will take part in a within-subject design in which they undergo rTMS to each target on separate days. Each target will be stimulated four times on a given day, and after each stimulation changes will be measured with: (1) REST-BOLD MRI (to assess FC changes), (2) TASK-BOLD MRI (to assess changes in BOLD activation on paradigms validated to test RDoC constructs), (3) state-based questionnaires or (4) neuropsychological tests. This work will facilitate individualized neuromodulation approaches based on network topography. This will pollinate large-scale clinical trials assessing the effects of differential circuit modulation. It will also illuminate circuit-construct relationships across neuropsychiatric disorders.

Registry
clinicaltrials.gov
Start Date
March 12, 2024
End Date
December 31, 2028
Last Updated
7 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mark C. Eldaief, MD

Assistant Professor of Neurology

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Blood oxygenation level dependent (BOLD) activation

Time Frame: 1 hour

Changes in activation resulting from performing a specific functional MRI (fMRI) task

Delayed Match to Sample Task

Time Frame: 5 minutes

Subjects match patterns to a recently viewed sample pattern. Score ranges from 0-30, with higher scores indicating better performance.

Applied Cognition-General Concerns scale

Time Frame: 10 minutes

Subjects rate how statements about cognition and attention apply to them, e.g., "Thinking is foggy." Score range is 8-40, with higher scores indicating lesser cognitive concerns.

Fawcett-Clark Pleasure Capacity Scale

Time Frame: 5-10 minutes

Subjects anticipate how much they would enjoy a certain scenario, e.g., "you sit watching a beautiful sunset in an isolated part of the world." Score range is 36 to 180, higher scores indicate higher pleasure capacity.

Face-name Associative Paradigm

Time Frame: 30 minutes

Subjects must remember names paired with certain faces (DN-A). Scores range from 0-32, with higher scores indicating better performance.

Reading the Mind Through the Eyes Test

Time Frame: 10 minutes

Subjects judge another person's mental state by looking at pictures of only their eyes. Score ranges from 0-41, higher scores indicate better performance.

Profile of Mood States Vigor subscale

Time Frame: 5 minutes

Subjects rate how much mood adjectives apply to them at that moment, e.g., "full of pep," "energetic," "vigorous." Score range 0-28, higher scores indicating more vigor.

Digit-Span Test

Time Frame: 5 minutes

Subjects repeat number lists in forward or reverse order (maximum score is 8 forwards and 8 backwards, higher scores indicate better performance).

The Simon Test

Time Frame: 5 minutes

Subjects press different buttons based on incongruent spatial and/or color cues. Scores range from 0-30, with higher scores indicating better performance.

Resting-state functional connectivity (FC)

Time Frame: 1 hour

Changes in connectivity within and between brain networks

Profile of Mood States Dejection subscale

Time Frame: 5 minutes

Subjects rate how much mood adjectives apply to them at that moment, e.g., "unworthy." Score range 0-28, higher scores indicating higher dejection.

State Shame and Guilt Scale

Time Frame: 5-10 minutes

Subjects rate how much certain statements apply to them, e.g., "I feel regret." Score range is 10-50, higher scores indicate more shame/guilt.

Tower of London Task

Time Frame: 5-10 minutes

Subjects plan a series of moves to match a start set to a goal set.

Profile of Mood States Tension subscale

Time Frame: 5 minutes

Subjects are asked to rate how much certain adjectives about their mood apply to them at that moment, e.g., "tense", "nervous", "shaky." Score range: 0-28, higher scores indicating more tension.

Study Sites (1)

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