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
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Single-Pulse Transcranial Magnetic Stimulation — DEVICE
    Single-pulse transcranial magnetic stimulation delivered during EEG or neuroimaging sessions for non-therapeutic mapping of cortical excitability and functional connectivity.
  • EEG-Synchronized Repetitive Transcranial Magnetic Stimulation (rTMS) — DEVICE
    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.
  • Cognitive Behavioral Therapy (CBT) — BEHAVIORAL
    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.
  • Cognitive Flexibility and Emotion Regulation Tasks — BEHAVIORAL
    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.
  • Non-Synchronized Repetitive Transcranial Magnetic Stimulation — DEVICE
    Repetitive transcranial magnetic stimulation delivered using standard stimulation parameters without EEG phase synchronization, serving as a comparator condition.

Study Details

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.

Key Dates

First listed
Aug 4, 2023
Start date
Feb 1, 2024
Status verified
Jun 2026
Primary completion
Oct 1, 2027
Completion
Oct 1, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Healthy Participants (Study 1)
    Healthy adult participants with no history of psychiatric or neurological illness who undergo mechanistic and modeling procedures, including multimodal neuroimaging, behavioral cognitive tasks, and non-therapeutic neurostimulation, to characterize brain networks underlying cognitive flexibility and emotion regulation.
  • Experimental: Depressed Participants - EEG-Synchronized rTMS (Studies 2 and 3)
    Participants 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.
  • Active Comparator: Depressed Participants - Non-Synchronized rTMS Comparator
    Participants with major depressive disorder who receive repetitive transcranial magnetic stimulation delivered using standard stimulation parameters without EEG phase synchronization, serving as a comparator condition.
  • Experimental: Depressed Participants - Cognitive Behavioral Therapy Only (Study 4)
    Participants 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.

Primary Outcome Measure

Change in Hamilton Depression Rating Scale (HAM-D) Score [ Time Frame: Baseline to Day 7 ]

Central Contacts

Locations (1)

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

Find similar trials in Charleston, SC

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Medical Univeristy of South Carolina· Charleston, SC

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