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Clinical Trials/NCT05977439
NCT05977439
Recruiting
Not Applicable

RECOVERS - Realigning Emotion and COgnition Via prEcision Regulation networkS - Phase I Study: Multimodal Computational Modeling of Cognitive Flexibility and Emotion Regulation Networks

Medical University of South Carolina1 site in 1 country30 target enrollmentFebruary 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Medical University of South Carolina
Enrollment
30
Locations
1
Primary Endpoint
Change in reaction time (RT) tasks - Incongruent Stimuli
Status
Recruiting
Last Updated
8 months ago

Overview

Brief Summary

In this research study, the investigators are examining how brain activity (electrical and blood flow) changes during tests of emotional processing, attention and memory in the magnetic resonance imaging (MRI) scanner and outside the MRI using functional near-infrared spectroscopy (fNIRS). Investigators are also using non-invasive brain stimulation to probe different parts of the brain and measuring brain activity (electrical and blood flow).

Study 1

This study includes healthy participants and researchers hope this will help us develop improved brain-based treatments for emotional difficulties like depression.

Study 2

This study includes participants with depression and researchers hope this will help us develop improved brain-based treatments for emotional difficulties like depression.

Detailed Description

Investigators hypothesize that targeted neuroplastic changes induced by individually-tailored rTMS will substantially reduce clinical symptoms underlying depression, anxiety and suicidality, and in general, revolutionize non-invasive treatments of mental health disorders. Investigators hypothesize that functional coupling in cognitive flexibility (CF) and emotion regulation (ER) networks is indexed by the phase of the brain's alpha oscillations. Using a novel integrated instrument that enables simultaneous functional magnetic resonance imaging (fMRI), electroencephalography (EEG) and transcranial magnetic stimulation (TMS), investigators propose to identify individualized stimulation parameters that reflect the strongest coupling of the CF/ER networks. Investigators will also use an instrument that enables simultaneous functional near-infrared spectroscopy (fNIRS), EEG, and TMS in attempt to identify the same parameters outside the scanner. The neuromechanistic model further posits that by applying repetitive TMS (rTMS) with these individualized parameters, one can induce entrainment in brain networks that drive neuroplastic changes in CF and ER. Study 1 This study is a proof-of-principle study in healthy control participants. Study 2 This study is a proof-of-principle study in participants with depression.

Registry
clinicaltrials.gov
Start Date
February 1, 2024
End Date
October 1, 2028
Last Updated
8 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in reaction time (RT) tasks - Incongruent Stimuli

Time Frame: Day 1, Day 2, Day 3

Tasks will be used to see differences between incongruent emotional stimuli.

Change in reaction time (RT) tasks - Congruent Stimuli

Time Frame: Day 1, Day 2, Day 3

Tasks will be used to see differences between congruent emotional stimuli.

Change in reaction time (RT) tasks and accuracy - Incongruent Stimuli

Time Frame: Day 1, Day 2, Day 3

Tasks will be used to see differences between incongruent emotional stimuli.

Change in reaction time (RT) tasks and accuracy - Congruent Stimuli

Time Frame: Day 1, Day 2, Day 3

Tasks will be used to see differences between congruent emotional stimuli.

Clinical Improvement

Time Frame: Day 13, Day 18

25% reduction in Generalized Anxiety Disorder -7 Questionnaire (GAD7) as a meaningful treatment response.

Study Sites (1)

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