RecruitingNot ApplicableNCT05977439

RECOVERS - Realigning Emotion and COgnition Via prEcision Regulation networkS

A Multiphase Program of Multimodal Computational Modeling and Hybrid Interventions Including EEG-Synchronized Transcranial Magnetic Stimulation and Cognitive Behavioral Therapy

Sponsor

Medical University of South Carolina

Enrollment

120 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

Depression Suicidal Ideation Major Depressive Disorder

Summary

In this research study, investigators examine how brain activity changes during tests of emotional processing, attention, and memory using multimodal neuroimaging methods including electroencephalography (EEG), functional magnetic resonance imaging (fMRI), and functional near-infrared spectroscopy (fNIRS). Transcranial magnetic stimulation (TMS) is used to probe and modulate brain networks related to cognitive flexibility and emotion regulation. The study includes multiple related sub-studies involving healthy participants and participants with depression. Some study components focus on mechanistic modeling using non-therapeutic neurostimulation in healthy participants, while other components include interventional approaches such as individualized EEG-synchronized repetitive TMS (rTMS), cognitive tasks, and brief cognitive behavioral therapy (CBT) in participants with depression. Certain study components also evaluate CBT alone without TMS to assess behavioral intervention effects.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This brain research study is investigating a technique called transcranial magnetic stimulation (TMS) combined with neurofeedback to help people regulate their emotions more effectively. The study is focused on understanding how specific brain networks involved in emotion and thinking can be strengthened in healthy volunteers. **You may be eligible if...** - You are 18–65 years old - You are generally healthy with no history of mental illness or physical health problems - English is your first language - You are able to have an MRI (no implanted metal devices) - You are not pregnant (if female) **You may NOT be eligible if...** - You have any current or past psychiatric diagnosis - You have a history of neurological conditions, concussion, seizures, brain tumors, or meningitis - You have had a head injury that caused loss of consciousness - You have significant visual impairment or cognitive difficulties that affect testing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESingle-Pulse Transcranial Magnetic Stimulation

Single-pulse transcranial magnetic stimulation delivered during EEG or neuroimaging sessions for non-therapeutic mapping of cortical excitability and functional connectivity.

DEVICEEEG-Synchronized Repetitive Transcranial Magnetic Stimulation (rTMS)

Repetitive transcranial magnetic stimulation delivered using individualized, EEG-derived stimulation parameters designed to synchronize stimulation timing with participants' alpha oscillatory phase. This closed-loop approach is intended to modulate neural networks underlying cognitive flexibility and emotion regulation. Stimulation may be delivered in accelerated sessions across multiple days.

BEHAVIORALCognitive Behavioral Therapy (CBT)

A structured, brief cognitive behavioral therapy program targeting depression and related symptoms, including cognitive restructuring, emotion regulation, and coping skill development, delivered in an accelerated format during the study period.

BEHAVIORALCognitive Flexibility and Emotion Regulation Tasks

Behavioral tasks designed to engage and assess cognitive flexibility and emotion regulation processes, performed during or adjacent to neurostimulation sessions or as part of study assessments.

DEVICENon-Synchronized Repetitive Transcranial Magnetic Stimulation

Repetitive transcranial magnetic stimulation delivered using standard stimulation parameters without EEG phase synchronization, serving as a comparator condition.