An interventional study of Single-Pulse Transcranial Magnetic Stimulation and EEG-Synchronized Repetitive Transcranial Magnetic Stimulation (rTMS) in Depression, Major Depressive Disorder and Suicidal Ideation, sponsored by Medical University of South Carolina. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment
Among 47 studies in Depression by Medical University of South Carolina — 17 open to participants now, 21 under way, none of them phase 3. Depression · Medical University of South Carolina.
Among the 47 studies in Depression by Medical University of South Carolina, this one is the 13th largest by planned enrollment of the 45 interventional ones, is one of 4 that started in 2024, is one of 31 with no phase, reaches primary completion later than 12 of the 20 other live ones, and was the 31st registered.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 120 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →17 of the 47 studies in Depression by Medical University of South Carolina are open now, in 1 country. Each count lists the studies.
Of the 1,088 Depression studies recruiting now, 469 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 310 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →47 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 4 started in 2024.
Median enrollment 46 across the 45 interventional studies, 10 across the 2 observational. Of the 24 that completed or were terminated, 14 (58%) have results posted.
Medical University of South Carolina is the lead sponsor of 874 studies on the registry; 166 are open to participants now.
Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.
10 of the studies in Depression by Medical University of South Carolina that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04657432Medical University of South CarolinaBrief, High-dose rTMS for Depression | 2026-12-01 |
| NCT07226011Medical University of South CarolinaAccelerated High-Dose tDCS for Depression | 2026-12-28 |
| NCT07369557Medical University of South CarolinaMindfulness Training During Accelerated TMS for Depression | 2026-12-30 |
| NCT06748209Medical University of South CarolinaEstablishing Mobile Transcranial Magnetic Stimulation | 2027-03-01 |
| NCT05497115Medical University of South CarolinaTesting a Scalable Model of Care to Improve Patients Access to Mental Health Services After Traumatic Injury | 2027-03-31 |
Among the 47 studies in Depression by Medical University of South Carolina, from their registry updates:
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.
Investigators aim to characterize and modulate brain networks underlying cognitive flexibility (CF) and emotion regulation (ER) using a multimodal, precision neuroscience approach. The central hypothesis is that functional coupling within CF and ER networks is indexed by the phase of the brain's alpha oscillations, and that targeted modulation of these networks through individualized neurostimulation can induce neuroplastic changes associated with improved clinical outcomes in depression and suicidality.
To test this hypothesis, investigators utilize a novel integrated system that enables simultaneous functional magnetic resonance imaging (fMRI), electroencephalography (EEG), and transcranial magnetic stimulation (TMS) to identify individualized stimulation parameters associated with optimal network coupling. A complementary system using functional near-infrared spectroscopy (fNIRS), EEG, and TMS is also used to extend these findings in a more scalable and accessible format.
This protocol includes multiple related sub-studies (Studies 1-4) conducted under a single IRB approval. These sub-studies are parallel investigations with differing populations and interventions and are not randomized arms of a single trial.
Study 1 is a proof-of-principle mechanistic study conducted in healthy adult participants. In this study, single-pulse TMS is delivered during EEG and neuroimaging sessions as a non-therapeutic probe to assess cortical excitability and functional connectivity during cognitive flexibility and emotion regulation tasks.
Study 2 is a proof-of-principle interventional study in participants with depression. It incorporates individualized, EEG-synchronized repetitive transcranial magnetic stimulation (rTMS) designed to entrain neural oscillatory dynamics within CF and ER networks. Participants may receive rTMS alone or in combination with cognitive tasks and brief cognitive behavioral therapy (CBT), with the goal of enhancing neuroplasticity and improving clinical symptoms.
Study 3 builds upon Study 2 and includes similar EEG-synchronized rTMS and CBT-based interventions in participants with depression, with ongoing refinements to stimulation parameters, task paradigms, and treatment delivery. This study further evaluates the reproducibility and effectiveness of individualized neurostimulation approaches.
Study 4 includes participants with depression who receive a course of cognitive behavioral therapy (CBT) along with MRI and behavioral assessments, without the use of TMS or EEG-based neurostimulation. This study allows for evaluation of behavioral intervention effects independent of neurostimulation.
Across interventional studies, rTMS may be delivered alone or in combination with cognitive flexibility and emotion regulation tasks or paired with CBT to promote synergistic effects on network engagement and neuroplasticity. These approaches are designed to test whether targeted modulation of CF and ER networks produces measurable changes in behavior, brain function, and clinical outcomes.
Participants in interventional studies may also complete ecological momentary assessment (EMA) surveys via mobile devices to monitor mood, stress, and safety in real time. These data may be used to capture dynamic changes in symptoms and may trigger predefined safety protocols and clinical follow-up when indicated.
Outcome measures across studies include changes in clinical symptoms (e.g., depression, anxiety, and suicidal ideation), behavioral performance on cognitive tasks, and neuroimaging-based measures of network connectivity and synchronization.
Study 1 (Healthy Participants)
Inclusion Criteria:
Exclusion Criteria:
Studies 2, 3, and 4 (Participants With Depression)
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy 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.
Device: Single-Pulse Transcranial Magnetic Stimulation · Behavioral: Cognitive Flexibility and Emotion Regulation Tasks
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.
Device: Single-Pulse Transcranial Magnetic Stimulation · Device: EEG-Synchronized Repetitive Transcranial Magnetic Stimulation (rTMS) · Behavioral: Cognitive Behavioral Therapy (CBT) · Behavioral: Cognitive Flexibility and Emotion Regulation Tasks
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.
Behavioral: Cognitive Behavioral Therapy (CBT) · Behavioral: Cognitive Flexibility and Emotion Regulation Tasks
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Day 7
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 7
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 7
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 7
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 7
Change in Functional Connectivity Strength (fMRI)
Change in functional connectivity within cognitive flexibility and emotion regulation networks measured using resting-state functional magnetic resonance imaging (fMRI), quantified as correlation coefficients between predefined brain regions.
Time frame: Baseline to Day 7
Proportion of Participants With ≥50% Change in Hamilton Depression Rating Scale (HAM-D) Score
Clinical response defined as a ≥50% change from baseline in Hamilton Depression Rating Scale (HAM-D) score.
Time frame: Day 28
Proportion of Participants With ≥50% Change in Brief Suicide Cognitions Scale (B-SCS) Score
Clinical response defined as a ≥50% change from baseline in Brief Suicide Cognitions Scale (B-SCS) score.
Time frame: Day 28.
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2024 (actual). Primary completion is estimated for Oct 2027, 44 months after the start.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 44 months is above that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medical University of South Carolina →