RECOVERS - Realigning Emotion and COgnition Via prEcision Regulation networkS

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.

Conditions

• Depression
• Major Depressive Disorder
• Suicidal Ideation

Interventions

DEVICE

Single-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.

DEVICE

EEG-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.

BEHAVIORAL

Cognitive 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.

BEHAVIORAL

Cognitive 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.

Sponsors & Collaborators

• Columbia University

  collaborator OTHER

• University of Oklahoma

  collaborator OTHER

• Defense Advanced Research Projects Agency

  collaborator FED

• University of Wisconsin, Madison

  collaborator OTHER

• Medical University of South Carolina

  lead OTHER

Principal Investigators

• Lisa McTeague, PhD · Medical University of South Carolina

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-02-01

Primary Completion

2027-10-01

Completion

2028-10-01

FDA Device

Yes

Countries

• United States

Study Locations