Major Depressive DisorderNCT05523817
Targeting Specific Brain Networks to Treat Specific Symptoms in Depression
A study testing Intermittent Theta Burst Stimulation (iTBS) in people with Major Depressive Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Repetitive transcranial magnetic stimulation (rTMS) is a way of non-invasively stimulating specific brain networks and is an established treatment for Major Depressive Disorder (MDD). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Intermittent Theta Burst Stimulation (iTBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2024to 31 May 2029
- 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
- 18-65 years of age
- Capacity to provide informed consent form to participate in the study
- Inclusion Criteria for participants with Major Depressive Disorder (MDD):
- 18-65 years of age
- Capacity to provide informed consent form to participate in the study
- Currently in a major depressive episode. Comorbid anxiety disorders and personality disorders will be allowed provided that MDD is the primary diagnosis.
Who cannot join
- Meeting criteria, in the past or currently, for bipolar affective disorder, hypomania or mania.
- Meeting criteria, in the past or currently, for a primary psychotic disorder (e.g., schizophrenia).
- Neurological conditions with known structural brain lesions, e.g., intracranial masses, multiple sclerosis.
- Any personal history of seizures or a family history of epilepsy in a first-degree relative.
- Metal in the body that is ferromagnetic or metallic injury to the eyes.
- Implanted pacemakers, medication pumps, vagal stimulators, deep brain stimulators, or ventriculoperitoneal shunts, etc.
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- Substance abuse or dependence that is current and active within the last six months, as indicated by self-report (e.g., heroin, cocaine, methamphetamines).
- Inability to meet the safety criteria for MRI scanning for any other reason.
- Severe or unstable medical illness.
- Currently pregnant, as assessed with urine pregnancy test in women of childbearing age.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02129
Mark Eldaief, MD, 617-726-1728, meldaief@partners.org
About this study
Official title: Probing the Functional and Behavioral Impact of Precision Circuit Modulation in Neuropsychiatric Diseases
Repetitive transcranial magnetic stimulation (rTMS) is a way of non-invasively stimulating specific brain networks and is an established treatment for Major Depressive Disorder (MDD). This proposal will reveal network mechanisms of the therapeutic effects of rTMS by investigating how stimulating each network specifically changes network connectivity and behavior. This will be done in a highly individualized manner in depressed and healthy patients, leading to more effective and more individualized treatments for depression.
Read the detailed description
Network models are increasingly invoked to characterize the neurobiological underpinnings of mental illnesses. Dysfunction within specific circuits promotes the formation of specific symptoms. This suggests an opportunity to treat specific symptoms by modulating specific circuits. Repetitive transcranial magnetic stimulation (rTMS) is capable of circuit-specific neuromodulation. It is also an established treatment for Major Depressive Disorder (MDD). Clinical experience suggests that rTMS treats different symptom constructs by stimulating different circuits. However, there remains a critical lack of mechanistic evidence to support putative network mechanisms of rTMS, limiting its ability to treat patients with more personalized and optimized approaches. This mechanistic proposal will first use resting-state functional connectivity (FC) MRI and customized analytic pipelines to characterize functional network topography in healthy and depressed individuals at high resolution.This data will be used to derive rTMS targets functionally situated in discrete prefrontal networks (e.g., control, default, salience, limbic/reward). Next, patients will take part in a within-subject design in which they undergo rTMS to each target on separate days. Each target will be stimulated four times on a given day, and after each stimulation changes will be measured with: (1) REST-BOLD MRI (to assess FC changes), (2) TASK-BOLD MRI (to assess changes in BOLD activation on paradigms validated to test RDoC constructs), (3) state-based questionnaires or (4) neuropsychological tests. This work will facilitate individualized neuromodulation approaches based on network topography. This will pollinate large-scale clinical trials assessing the effects of differential circuit modulation. It will also illuminate circuit-construct relationships across neuropsychiatric disorders.
- Conditions
- Major Depressive Disorder
- Being tested
- Intermittent Theta Burst Stimulation (iTBS)
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Theta Burst Stimulation (iTBS)Device
Also called Repetitive Transcranial Magnetic Stimulation
iTBS is a form of non-invasive brain stimulation used to treat depression. It works on the principles of electromagnetic induction.
| Study group | Role | What they receive |
|---|---|---|
| DLPFC Salience network target | Experimental | iTBS delivered four times daily to an individually defined salience network representation in left dorsolateral prefrontal cortex (DLPFC). Receives: Device: Intermittent Theta Burst Stimulation (iTBS) |
| DLPFC Control network target | Experimental | iTBS delivered four times daily to an individually defined control network representation in left dorsolateral prefrontal cortex (DLPFC). Receives: Device: Intermittent Theta Burst Stimulation (iTBS) |
| DLPFC Default network A target | Experimental | iTBS delivered four times daily to an individually defined default network A representation in left dorsolateral prefrontal cortex (DLPFC). Receives: Device: Intermittent Theta Burst Stimulation (iTBS) |
| dmPFC Default network B target | Experimental | iTBS delivered four times daily to an individually defined default network B representation in left dorsomedial prefrontal cortex (DMPFC). Receives: Device: Intermittent Theta Burst Stimulation (iTBS) |
| vmPFC limbic-reward network target | Experimental | iTBS delivered four times daily to an individually defined reward network representation in left ventromedial prefrontal cortex (vMPFC). Receives: Device: Intermittent Theta Burst Stimulation (iTBS) |
| SHAM stimulation | Sham comparator | SHAM iTBS delivered four times daily to an individually defined SHAM region in left dorsolateral prefrontal cortex (DLPFC). Receives: Device: Intermittent Theta Burst Stimulation (iTBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting-state functional connectivity (FC)
Changes in connectivity within and between brain networks
Measured: 1 hour
Blood oxygenation level dependent (BOLD) activation
Changes in activation resulting from performing a specific functional MRI (fMRI) task
Measured: 1 hour
Applied Cognition-General Concerns scale
Subjects rate how statements about cognition and attention apply to them, e.g., "Thinking is foggy." Score range is 8-40, with higher scores indicating lesser cognitive concerns.
Measured: 10 minutes
Profile of Mood States Tension subscale
Subjects are asked to rate how much certain adjectives about their mood apply to them at that moment, e.g., "tense", "nervous", "shaky." Score range: 0-28, higher scores indicating more tension.
Measured: 5 minutes
Profile of Mood States Vigor subscale
Subjects rate how much mood adjectives apply to them at that moment, e.g., "full of pep," "energetic," "vigorous." Score range 0-28, higher scores indicating more vigor.
Measured: 5 minutes
Profile of Mood States Dejection subscale
Subjects rate how much mood adjectives apply to them at that moment, e.g., "unworthy." Score range 0-28, higher scores indicating higher dejection.
Measured: 5 minutes
State Shame and Guilt Scale
Subjects rate how much certain statements apply to them, e.g., "I feel regret." Score range is 10-50, higher scores indicate more shame/guilt.
Measured: 5-10 minutes
Fawcett-Clark Pleasure Capacity Scale
Subjects anticipate how much they would enjoy a certain scenario, e.g., "you sit watching a beautiful sunset in an isolated part of the world." Score range is 36 to 180, higher scores indicate higher pleasure capacity.
Measured: 5-10 minutes
Digit-Span Test
Subjects repeat number lists in forward or reverse order (maximum score is 8 forwards and 8 backwards, higher scores indicate better performance).
Measured: 5 minutes
Tower of London Task
Subjects plan a series of moves to match a start set to a goal set.
Measured: 5-10 minutes
Delayed Match to Sample Task
Subjects match patterns to a recently viewed sample pattern. Score ranges from 0-30, with higher scores indicating better performance.
Measured: 5 minutes
The Simon Test
Subjects press different buttons based on incongruent spatial and/or color cues. Scores range from 0-30, with higher scores indicating better performance.
Measured: 5 minutes
Face-name Associative Paradigm
Subjects must remember names paired with certain faces (DN-A). Scores range from 0-32, with higher scores indicating better performance.
Measured: 30 minutes
Reading the Mind Through the Eyes Test
Subjects judge another person's mental state by looking at pictures of only their eyes. Score ranges from 0-41, higher scores indicate better performance.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start12 Mar 2024
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Within-subject crossover study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Mark C. Eldaief, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523817
- Sponsor's protocol ID
- 2022P002110
- Other IDs
- 1R01MH129367-01A1
- Status last verified
- Oct 2026
- First submitted
- 14 Aug 2022
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This project will adhere to the NIH Grant Policy on Sharing of Unique Research Resources including the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources. The results of this research will be made available via publication in scientific journals and through scientific meetings where our findings are reported. Publication of data shall occur during the project, if appropriate, or at the end of the project, consistent with normal scientific practices. All publications will be made publicly available consistent with NIH policies. Such research data will be redacted to prevent the disclosure of personal identifiers.
Publications
Eldaief MC, Halko MA, Buckner RL, Pascual-Leone A. Transcranial magnetic stimulation modulates the brain's intrinsic activity in a frequency-dependent manner. Proc Natl Acad Sci U S A. 2011 Dec 27;108(52):21229-34. doi: 10.1073/pnas.1113103109. Epub 2011 Dec 12.
PubMed 22160708Fox MD, Halko MA, Eldaief MC, Pascual-Leone A. Measuring and manipulating brain connectivity with resting state functional connectivity magnetic resonance imaging (fcMRI) and transcranial magnetic stimulation (TMS). Neuroimage. 2012 Oct 1;62(4):2232-43. doi: 10.1016/j.neuroimage.2012.03.035. Epub 2012 Mar 19.
PubMed 22465297
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probing the Functional and Behavioral Impact of Precision Circuit Modulation in Neuropsychiatric Diseases
- ClinicalTrials.gov ID
- NCT05523817
- Acronym / sponsor ID
- 2022P002110
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 31 Aug 2022 (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.
Repetitive transcranial magnetic stimulation (rTMS) is a way of non-invasively stimulating specific brain networks and is an established treatment for Major Depressive Disorder (MDD). This proposal will reveal network mechanisms of the therapeutic effects of rTMS by investigating how stimulating each network specifically changes network connectivity and behavior. This will be done in a highly individualized manner in depressed and healthy patients, leading to more effective and more individualized treatments for depression.
Detailed description
Network models are increasingly invoked to characterize the neurobiological underpinnings of mental illnesses. Dysfunction within specific circuits promotes the formation of specific symptoms. This suggests an opportunity to treat specific symptoms by modulating specific circuits. Repetitive transcranial magnetic stimulation (rTMS) is capable of circuit-specific neuromodulation. It is also an established treatment for Major Depressive Disorder (MDD). Clinical experience suggests that rTMS treats different symptom constructs by stimulating different circuits. However, there remains a critical lack of mechanistic evidence to support putative network mechanisms of rTMS, limiting its ability to treat patients with more personalized and optimized approaches. This mechanistic proposal will first use resting-state functional connectivity (FC) MRI and customized analytic pipelines to characterize functional network topography in healthy and depressed individuals at high resolution.This data will be used to derive rTMS targets functionally situated in discrete prefrontal networks (e.g., control, default, salience, limbic/reward). Next, patients will take part in a within-subject design in which they undergo rTMS to each target on separate days. Each target will be stimulated four times on a given day, and after each stimulation changes will be measured with: (1) REST-BOLD MRI (to assess FC changes), (2) TASK-BOLD MRI (to assess changes in BOLD activation on paradigms validated to test RDoC constructs), (3) state-based questionnaires or (4) neuropsychological tests. This work will facilitate individualized neuromodulation approaches based on network topography. This will pollinate large-scale clinical trials assessing the effects of differential circuit modulation. It will also illuminate circuit-construct relationships across neuropsychiatric disorders.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
- Model description
- Within-subject crossover study
| Arm | Type | Receives |
|---|---|---|
| DLPFC Salience network target | Experimental | Device: Intermittent Theta Burst Stimulation (iTBS)iTBS delivered four times daily to an individually defined salience network representation in left dorsolateral prefrontal cortex (DLPFC). |
| DLPFC Control network target | Experimental | Device: Intermittent Theta Burst Stimulation (iTBS)iTBS delivered four times daily to an individually defined control network representation in left dorsolateral prefrontal cortex (DLPFC). |
| DLPFC Default network A target | Experimental | Device: Intermittent Theta Burst Stimulation (iTBS)iTBS delivered four times daily to an individually defined default network A representation in left dorsolateral prefrontal cortex (DLPFC). |
| dmPFC Default network B target | Experimental | Device: Intermittent Theta Burst Stimulation (iTBS)iTBS delivered four times daily to an individually defined default network B representation in left dorsomedial prefrontal cortex (DMPFC). |
| vmPFC limbic-reward network target | Experimental | Device: Intermittent Theta Burst Stimulation (iTBS)iTBS delivered four times daily to an individually defined reward network representation in left ventromedial prefrontal cortex (vMPFC). |
| SHAM stimulation | Sham comparator | Device: Intermittent Theta Burst Stimulation (iTBS)SHAM iTBS delivered four times daily to an individually defined SHAM region in left dorsolateral prefrontal cortex (DLPFC). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-65 years of age
- Capacity to provide informed consent form to participate in the study
- 18-65 years of age
- Capacity to provide informed consent form to participate in the study
- Currently in a major depressive episode. Comorbid anxiety disorders and personality disorders will be allowed provided that MDD is the primary diagnosis.
Key exclusion criteria (10 listed)
- Meeting criteria, in the past or currently, for bipolar affective disorder, hypomania or mania.
- Meeting criteria, in the past or currently, for a primary psychotic disorder (e.g., schizophrenia).
- Neurological conditions with known structural brain lesions, e.g., intracranial masses, multiple sclerosis.
- Any personal history of seizures or a family history of epilepsy in a first-degree relative.
- Metal in the body that is ferromagnetic or metallic injury to the eyes.
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 |
|---|---|---|
| Intermittent Theta Burst Stimulation (iTBS)Also: Repetitive Transcranial Magnetic StimulationiTBS is a form of non-invasive brain stimulation used to treat depression. It works on the principles of electromagnetic induction. | Device | DLPFC Control network target, DLPFC Default network A target, DLPFC Salience network target, SHAM stimulation, dmPFC Default network B target, vmPFC limbic-reward network target |
Primary outcome
Resting-state functional connectivity (FC)
Time frame: 1 hour
Changes in connectivity within and between brain networks
Blood oxygenation level dependent (BOLD) activation
Time frame: 1 hour
Changes in activation resulting from performing a specific functional MRI (fMRI) task
Applied Cognition-General Concerns scale
Time frame: 10 minutes
Subjects rate how statements about cognition and attention apply to them, e.g., "Thinking is foggy." Score range is 8-40, with higher scores indicating lesser cognitive concerns.
Profile of Mood States Tension subscale
Time frame: 5 minutes
Subjects are asked to rate how much certain adjectives about their mood apply to them at that moment, e.g., "tense", "nervous", "shaky." Score range: 0-28, higher scores indicating more tension.
Profile of Mood States Vigor subscale
Time frame: 5 minutes
Subjects rate how much mood adjectives apply to them at that moment, e.g., "full of pep," "energetic," "vigorous." Score range 0-28, higher scores indicating more vigor.
Profile of Mood States Dejection subscale
Time frame: 5 minutes
Subjects rate how much mood adjectives apply to them at that moment, e.g., "unworthy." Score range 0-28, higher scores indicating higher dejection.
State Shame and Guilt Scale
Time frame: 5-10 minutes
Subjects rate how much certain statements apply to them, e.g., "I feel regret." Score range is 10-50, higher scores indicate more shame/guilt.
Fawcett-Clark Pleasure Capacity Scale
Time frame: 5-10 minutes
Subjects anticipate how much they would enjoy a certain scenario, e.g., "you sit watching a beautiful sunset in an isolated part of the world." Score range is 36 to 180, higher scores indicate higher pleasure capacity.
Digit-Span Test
Time frame: 5 minutes
Subjects repeat number lists in forward or reverse order (maximum score is 8 forwards and 8 backwards, higher scores indicate better performance).
Tower of London Task
Time frame: 5-10 minutes
Subjects plan a series of moves to match a start set to a goal set.
Delayed Match to Sample Task
Time frame: 5 minutes
Subjects match patterns to a recently viewed sample pattern. Score ranges from 0-30, with higher scores indicating better performance.
The Simon Test
Time frame: 5 minutes
Subjects press different buttons based on incongruent spatial and/or color cues. Scores range from 0-30, with higher scores indicating better performance.
Face-name Associative Paradigm
Time frame: 30 minutes
Subjects must remember names paired with certain faces (DN-A). Scores range from 0-32, with higher scores indicating better performance.
Reading the Mind Through the Eyes Test
Time frame: 10 minutes
Subjects judge another person's mental state by looking at pictures of only their eyes. Score ranges from 0-41, higher scores indicate better performance.
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 9 Oct 2026.
- Background: PubMed 22160708Eldaief MC, Halko MA, Buckner RL, Pascual-Leone A. Transcranial magnetic stimulation modulates the brain's intrinsic activity in a frequency-dependent manner. Proc Natl Acad Sci U S A. 2011 Dec 27;108(52):21229-34. doi: 10.1073/pnas.1113103109. Epub 2011 Dec 12.
- Background: PubMed 22465297Fox MD, Halko MA, Eldaief MC, Pascual-Leone A. Measuring and manipulating brain connectivity with resting state functional connectivity magnetic resonance imaging (fcMRI) and transcranial magnetic stimulation (TMS). Neuroimage. 2012 Oct 1;62(4):2232-43. doi: 10.1016/j.neuroimage.2012.03.035. Epub 2012 Mar 19.
- Individual participant dataSharing planned: No. This project will adhere to the NIH Grant Policy on Sharing of Unique Research Resources including the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources. The results of this research will be made available via publication in scientific journals and through scientific meetings where our findings are reported. Publication of data shall occur during the project, if appropriate, or at the end of the project, consistent with normal scientific practices. All publications will be made publicly available consistent with NIH policies. Such research data will be redacted to prevent the disclosure of personal identifiers.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Theta Burst Stimulation (iTBS) in people with Major Depressive Disorder, run by Massachusetts General Hospital 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 6 inclusion and 10 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 9 Oct 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting-state functional connectivity (FC) (time frame: 1 hour). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05523817, which also lists 2 linked publications.
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 9 Oct 2026.