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
1 other identifier
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable depression
Started Feb 2024
Longer than P75 for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2023
CompletedFirst Posted
Study publicly available on registry
August 4, 2023
CompletedStudy Start
First participant enrolled
February 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
July 21, 2026
July 1, 2026
3.7 years
June 29, 2023
July 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in Hamilton Depression Rating Scale (HAM-D) Score
hange in clinician-rated depression severity measured using the Hamilton Depression Rating Scale (HAM-D). Scores range from 0 to 52; higher scores indicate more severe depression.
Baseline to Day 7
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Change in self-reported depression severity measured using the Patient Health Questionnaire-9 (PHQ-9). Scores range from 0 to 27; higher scores indicate more severe depression.
Baseline to Day 7
Change in Suicide Cognitions (Brief Suicide Cognitions Scale [B-SCS])
Change in suicide-related cognitions measured using the Brief Suicide Cognitions Scale (B-SCS). Higher scores indicate greater severity of maladaptive suicide-related cognitions.
Baseline to Day 7
Secondary Outcomes (7)
Change in Reaction Time During Cognitive Flexibility Tasks
Baseline to Day 7
Change in Accuracy on Cognitive Flexibility Tasks
Baseline to Day 7
Change in Generalized Anxiety Disorder-7 (GAD-7) Score
Baseline to Day 7
Change in EEG Alpha Phase Synchronization
Baseline to Day 7
Change in Functional Connectivity Strength (fMRI)
Baseline to Day 7
- +2 more secondary outcomes
Study Arms (3)
Healthy Participants (Study 1)
EXPERIMENTALHealthy adult participants with no history of psychiatric or neurological illness who undergo mechanistic and modeling procedures, including multimodal neuroimaging, behavioral cognitive tasks, and nontherapeutic neurostimulation, to characterize brain networks underlying cognitive flexibility and emotion regulation.
Depressed Participants - EEG-Synchronized rTMS (Studies 2 and 3)
EXPERIMENTALParticipants with major depressive disorder who receive individualized, EEG-synchronized repetitive transcranial magnetic stimulation (rTMS), delivered alone or in combination with cognitive tasks and/or brief cognitive behavioral therapy (CBT), to modulate neural networks underlying cognitive flexibility and emotion regulation.
Depressed Participants - Cognitive Behavioral Therapy Only (Study 4)
EXPERIMENTALParticipants with major depressive disorder who receive a course of cognitive behavioral therapy (CBT) along with MRI and behavioral assessments, without transcranial magnetic stimulation or EEG-based neurostimulation. This group allows evaluation of behavioral intervention effects independent of neurostimulation.
Interventions
Single-pulse transcranial magnetic stimulation delivered during EEG or neuroimaging sessions for non-therapeutic mapping of cortical excitability and functional connectivity.
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.
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 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.
Eligibility Criteria
You may qualify if:
- Age 18-65 years
- Medically and psychiatrically healthy with no history of psychiatric or neurological disorders
- English-speaking
- Capacity to provide informed consent
- Willingness and ability to complete study procedures
- Negative pregnancy test for participants of childbearing potential
You may not qualify if:
- Any current or past psychiatric diagnosis
- Neurological disorders or history of central nervous system disease
- History of seizure or epilepsy or use of medications that lower seizure threshold
- Significant head injury or loss of consciousness
- Implanted metal or contraindications to MRI or TMS
- Substance use disorder (excluding nicotine or caffeine)
- Pregnancy or plans to become pregnant during study participation
- Inability to complete study procedures
- Studies 2, 3, and 4 (Participants With Depression)
- Age 18-65 years
- Current diagnosis of Major Depressive Disorder (MDD)
- Depression severity consistent with study criteria (e.g., HAM-D ≥17)
- No history of psychotic or bipolar disorders
- English-speaking
- Capacity to provide informed consent
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical University of South Carolinalead
- Columbia Universitycollaborator
- University of Oklahomacollaborator
- Defense Advanced Research Projects Agencycollaborator
- University of Wisconsin, Madisoncollaborator
Study Sites (1)
Medical Univeristy of South Carolina
Charleston, South Carolina, 29425, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lisa McTeague, PhD
Medical University of South Carolina
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2023
First Posted
August 4, 2023
Study Start
February 1, 2024
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2028
Last Updated
July 21, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share