RECOVERS - Realigning Emotion and COgnition Via prEcision Regulation networkS

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT05977439
Status
Recruiting
Apply to this trial

Conditions

  • Depression - Major Depressive Disorder
  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • fMRI-EEG-TMS — DEVICE
    Participants will undergo a magnetic resonance imaging (MRI) scan with combined electroencephalography (EEG), and single-pulse transcranial magnetic stimulation (TMS) while completing cognitive flexibility (CF) and emotion recognition (CR) tasks.
  • fNIRS-EEG-TMS — DEVICE
    Participants brain activity will be measured using functional near-infrared spectroscopy (fNIRS) with combined electroencephalography (EEG), and single-pulse transcranial magnetic stimulation (TMS) while completing cognitive flexibility (CF) and emotion recognition (CR) tasks.
  • fNIRS-EEG-rTMS Interleaved with CBT — DEVICE
    Participants brain activity will be measured using functional near-infrared spectroscopy (fNIRS) with combined electroencephalography (EEG), and repetitive transcranial magnetic stimulation (rTMS). rTMS will be delivered via a MagVenture MagPro100 and Cool-B65 coil. The investigators will use a standard resting motor threshold (rMT) determination to determine the TMS dose. Treatment will be delivered at 120% of the motor threshold. The accelerated paradigm will consist 6 session a day for 5-6 days. Each rTMS session will be separated by 30 minutes of Cognitive Behavioral Therapy (CBT). rTMS treatment will be delivered at an individualized left DLPFC target based on each participant's individualized scans from prior neuroimaging sessions.

Study Details

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.

Key Dates

Start date
Feb 1, 2024
Status verified
Aug 2025
Primary completion
Oct 1, 2027
Completion
Oct 1, 2028

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Healthy Participants
    Endorse good health with no history of mental or physical illness or implanted metal
  • Arm: Depressed Participants
    Endorse current depression, identified via the Hamilton Depression Rating Scale (HAM-D scores ≥ 17), but no history of psychosis or mania, determined via the Quick Structured Clinical Interview for DSM-5 Disorders (SCID).

Primary Outcome Measure

Change in reaction time (RT) tasks - Incongruent Stimuli [ Time Frame: Day 1, Day 2, Day 3 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical Univeristy of South CarolinaCharlestonSouth Carolina29425
Lisa M McTeague, PhD
[email protected]
843-792-8274
Jacob Eade
[email protected]

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By research site
Medical Univeristy of South Carolina· Charleston, SC

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