RECOVERS - Realigning Emotion and COgnition Via PrEcision Regulation NetworkS

Recruiting

• Conditions: Healthy; Depression - Major Depressive Disorder

• Registration Number: NCT05977439
• Lead Sponsor: Medical University of South Carolina

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.

Study Timeline

• Study First Submitted: 2023-06-29
• Study First Submitted QC: 2023-07-26
• Study First Posted: 2023-08-04
• Study Start: 2024-02-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-16
• Primary Completion: 2027-10-01
• Study Completion: 2028-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in reaction time (RT) tasks - Incongruent Stimuli	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	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	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	Day 1, Day 2, Day 3	Tasks will be used to see differences between congruent emotional stimuli.
Clinical Improvement	Day 13, Day 18	25% reduction in Generalized Anxiety Disorder -7 Questionnaire (GAD7) as a meaningful treatment response.

Trial Locations

Locations (1)

Medical Univeristy of South Carolina; 🇺🇸 Charleston, South Carolina, United States