RECOVERS - Realigning Emotion and COgnition Via prEcision Regulation networkS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMedical University of South Carolina
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Age 18-65 years
Medically and psychiatrically healthy with no history of psychiatric or neurological disorders
English-speaking
Capacity to provide informed consent
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Single-Pulse Transcranial Magnetic Stimulation
DeviceSingle-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)
DeviceRepetitive 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)
BehavioralA 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
BehavioralBehavioral 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
DeviceRepetitive transcranial magnetic stimulation delivered using standard stimulation parameters without EEG phase synchronization, serving as a comparator condition.
Treatment groups
120 Participants
are divided into 4 treatment groupsGroup A: Healthy Participants (Study 1)Other 2 interventions
Group B: Depressed Participants - EEG-Synchronized rTMS (Studies 2 and 3)Experimental treatment 4 interventions
Group C: Depressed Participants - Non-Synchronized rTMS ComparatorActive comparator 3 interventions
Group D: Depressed Participants - Cognitive Behavioral Therapy Only (Study 4)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in Hamilton Depression Rating Scale (HAM-D) Score
Change 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.
Time frame
Baseline to Day 72
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.
Time frame
Baseline to Day 73
Change in Suicidal Ideation Severity (Passive and Active Suicidal Ideation Scale [PASIS])
Change in suicidal ideation severity measured using the Passive and Active Suicidal Ideation Scale (PASIS). Higher scores indicate greater severity of suicidal ideation.
Time frame
Baseline to Day 7Secondary outcomes
1
Change in Reaction Time During Cognitive Flexibility Tasks
Change in reaction time (milliseconds) during cognitive flexibility and emotion regulation tasks under congruent and incongruent conditions.
Time frame
Baseline to Day 72
Change in Accuracy on Cognitive Flexibility Tasks
Change in task accuracy (percentage correct responses) during cognitive flexibility and emotion regulation tasks.
Time frame
Baseline to Day 73
Change in Generalized Anxiety Disorder-7 (GAD-7) Score
Change in anxiety severity measured using the Generalized Anxiety Disorder 7-item scale (GAD-7). Scores range from 0 to 21; higher scores indicate more severe anxiety.
Time frame
Baseline to Day 74
Change in EEG Alpha Phase Synchronization
Change in EEG alpha phase synchronization measured as phase-locking value (PLV) during cognitive task performance and neurostimulation sessions.
Time frame
Baseline to Day 7Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University of South Carolina
Lead sponsor
Columbia University
Collaborator
University of Oklahoma
Collaborator
Defense Advanced Research Projects Agency
Collaborator
University of Wisconsin, Madison
Collaborator
Source ClinicalTrials.gov