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RECOVERS - Realigning Emotion and COgnition Via prEcision Regulation networkS

RECRUITINGN/ASponsored by Medical University of South Carolina
Actively Recruiting
PhaseN/A
SponsorMedical University of South Carolina
Started2024-02-01
Est. completion2027-10-01
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years – 65 YearsHealthy volunteers accepted
Study 1 (Healthy Participants)

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Inclusion Criteria:

* 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
* Willingness and ability to complete study procedures
* Negative pregnancy test for participants of childbearing potential

Exclusion Criteria:

* 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)
* Current participation in another interventional clinical trial
* Pregnancy or plans to become pregnant during study participation
* Any condition that would interfere with safe participation or completion of study procedures

Conditions5

DepressionDepression - Major Depressive DisorderHealthyMajor Depressive DisorderSuicidal Ideation

Locations1 site

Medical Univeristy of South Carolina
Charleston, South Carolina, 29425
Lisa M McTeague, PhD843-792-8274mcteague@musc.edu

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