DepressionNCT05977439
RECOVERS - Realigning Emotion and COgnition Via prEcision Regulation networkS
A study testing Single-Pulse Transcranial Magnetic Stimulation, EEG-Synchronized Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive Behavioral Therapy (CBT) in people with Depression and Major Depressive Disorder, run by Medical University of South Carolina at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Major Depressive Disorder, Suicidal Ideation
- What is being tested?
- Single-Pulse Transcranial Magnetic Stimulation, EEG-Synchronized Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive Behavioral Therapy (CBT)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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)
Show all 17Show fewer
- Pregnancy or plans to become pregnant during study participation
- Inability to complete study procedures
- Studies 2, 3, and 4 (Participants With Depression)
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jayce Doose contact
United States1 site, 1 recruiting
- Recruiting
Medical Univeristy of South Carolina
Charleston, South Carolina, 29425
Lisa M McTeague, PhD, 843-792-8274, mcteague@musc.edu
Christina Marsicano, chm275@musc.edu
About this study
Official title: A Multiphase Program of Multimodal Computational Modeling and Hybrid Interventions Including EEG-Synchronized Transcranial Magnetic Stimulation and Cognitive Behavioral Therapy
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.
Read the detailed description
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.
- Conditions
- Depression, Major Depressive Disorder, Suicidal Ideation
- Being tested
- Single-Pulse Transcranial Magnetic Stimulation, EEG-Synchronized Repetitive Transcranial Magnetic Stimulation (rTMS), Cognitive Behavioral Therapy (CBT), Cognitive Flexibility and Emotion Regulation Tasks
- Keywords
- transcranial magnetic stimulation, EEG-synchronized rTMS, closed-loop neurostimulation, depression, suicide prevention, cognitive behavioral therapy (CBT), neuroplasticity
- Medical subject headings
- Depression, Depressive Disorder, Major, Suicidal Ideation, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Pulse Transcranial Magnetic StimulationDevice
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)Behavioural
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 TasksBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participants (Study 1) | Experimental | 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. Receives: Device: Single-Pulse Transcranial Magnetic Stimulation; Behavioral: Cognitive Flexibility and Emotion Regulation Tasks |
| Depressed Participants - EEG-Synchronized rTMS (Studies 2 and 3) | Experimental | 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. Receives: 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 |
| Depressed Participants - Cognitive Behavioral Therapy Only (Study 4) | Experimental | 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. Receives: Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Cognitive Flexibility and Emotion Regulation Tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline to Day 7
Secondary outcomes (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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 Feb 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Groups described in this record correspond to cohorts within multiple related sub-studies and are not randomized arms of a single trial.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, University of Oklahoma, Defense Advanced Research Projects Agency, University of Wisconsin, Madison
- Responsible party
- Sponsor
- Investigators
- Lisa McTeague, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977439
- Sponsor's protocol ID
- 00129566
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2023
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiphase Program of Multimodal Computational Modeling and Hybrid Interventions Including EEG-Synchronized Transcranial Magnetic Stimulation and Cognitive Behavioral Therapy
- ClinicalTrials.gov ID
- NCT05977439
- Acronym / sponsor ID
- 00129566
- Conditions
- Depression, Major Depressive Disorder, Suicidal Ideation
- Keywords
- transcranial magnetic stimulation, EEG-synchronized rTMS, closed-loop neurostimulation, depression, suicide prevention, cognitive behavioral therapy (CBT), neuroplasticity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Columbia University, University of Oklahoma, Defense Advanced Research Projects Agency, University of Wisconsin, Madison
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Groups described in this record correspond to cohorts within multiple related sub-studies and are not randomized arms of a single trial.
| Arm | Type | Receives |
|---|---|---|
| Healthy Participants (Study 1) | Experimental | Device: Single-Pulse Transcranial Magnetic Stimulation, Behavioral: Cognitive Flexibility and Emotion Regulation TasksHealthy 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. |
| Depressed Participants - EEG-Synchronized rTMS (Studies 2 and 3) | Experimental | 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 TasksParticipants 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. |
| Depressed Participants - Cognitive Behavioral Therapy Only (Study 4) | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT), Behavioral: Cognitive Flexibility and Emotion Regulation TasksParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-Pulse Transcranial Magnetic StimulationSingle-pulse transcranial magnetic stimulation delivered during EEG or neuroimaging sessions for non-therapeutic mapping of cortical excitability and functional connectivity. | Device | Depressed Participants - EEG-Synchronized rTMS (Studies 2 and 3), Healthy Participants (Study 1) |
| EEG-Synchronized Repetitive Transcranial Magnetic Stimulation (rTMS)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. | Device | Depressed Participants - EEG-Synchronized rTMS (Studies 2 and 3) |
| Cognitive Behavioral Therapy (CBT)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. | Behavioural | Depressed Participants - Cognitive Behavioral Therapy Only (Study 4), Depressed Participants - EEG-Synchronized rTMS (Studies 2 and 3) |
| Cognitive Flexibility and Emotion Regulation TasksBehavioral 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. | Behavioural | Depressed Participants - Cognitive Behavioral Therapy Only (Study 4), Depressed Participants - EEG-Synchronized rTMS (Studies 2 and 3), Healthy Participants (Study 1) |
Primary outcome
Change in Hamilton Depression Rating Scale (HAM-D) Score
Time frame: Baseline to Day 7
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.
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Time frame: Baseline to Day 7
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.
Change in Suicide Cognitions (Brief Suicide Cognitions Scale [B-SCS])
Time frame: Baseline to Day 7
Change in suicide-related cognitions measured using the Brief Suicide Cognitions Scale (B-SCS). Higher scores indicate greater severity of maladaptive suicide-related cognitions.
7 secondary outcomes
Change in Reaction Time During Cognitive Flexibility Tasks
Time frame: Baseline to Day 7
Change in Accuracy on Cognitive Flexibility Tasks
Time frame: Baseline to Day 7
Change in Generalized Anxiety Disorder-7 (GAD-7) Score
Time frame: Baseline to Day 7
Change in EEG Alpha Phase Synchronization
Time frame: Baseline to Day 7
Change in Functional Connectivity Strength (fMRI)
Time frame: Baseline to Day 7
Proportion of Participants With ≥50% Change 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
Time frame: Day 28.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Depression
RecruitingPhase 2
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Anxiety Disorders, Major Depressive Disorder
Recruiting
Virtual Reality Intervention to Improve Psychological Symptom Burden for Cancer Patients Undergoing Treatment
Adjustment Disorder, Anxiety Disorder
Recruiting
Teenthrive 2: Treatments for Improving Mood in Teens
Depression in Adolescence
Active, not recruiting
Developing and Testing an Online Pathway From Screening to Treatment for Depression in Oncology: iPath*D (Aim 2)
Cancer, Depression
RecruitingPhase 2
Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder
Major Depressive Disorder (MDD), Alcohol Use Disorder (AUD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jayce Doose contact
Lisa McTeague, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-Pulse Transcranial Magnetic Stimulation, EEG-Synchronized Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive Behavioral Therapy (CBT) in people with Depression and Major Depressive Disorder, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa McTeague, PhD (843-792-8274, MCTEAGUE@MUSC.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamilton Depression Rating Scale (HAM-D) Score (time frame: Baseline to Day 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.