Transcranial Magnetic Stimulation, RepetitiveTMS-DEP-2024NCT07207239
Effect of Theta-burst rTMS Therapy on the Clinical and Cognitive Symptoms of Patients With Therapy Resistant Depression and Response Prediction With Neuroimaging Methods.
A study testing repetative Transcranial Magnetic Stimulation (rTMS), theta-burst protocol in people with Transcranial Magnetic Stimulation, Repetitive and Depression - Major Depressive Disorder, run by Semmelweis University at 1 site in Hungary.
Trial summary
The primary aim of the study is to find the combination of neuroimaging-related markers, demographics, and clinical characteristics that predict the response of patients with therapy-resistant depression to theta-burst rTMS treatment. The secondary aim is to monitor the cognitive effects of TMS therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transcranial Magnetic Stimulation, Repetitive, Depression - Major Depressive Disorder
- What is being tested?
- repetative Transcranial Magnetic Stimulation (rTMS), theta-burst protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteHungary
- Study dates
- 13 Jun 2025to 13 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of depression
- 18 years of age
- Beck depression inventory score above 12 (screening)
- MADRS score above 6 (baseline)
Who cannot join
- serious cognitive impairment
- mental retardation
- history of head injury with loss of consciousness for more than 1 hour
- alcohol or drug abuse within the past 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site
Department of Psychiatry and Psychotherapy
Budapest, Pest County, 1083
About this study
The primary aim of the study is to find the combination of neuroimaging-related markers, demographics, and clinical characteristics that predict the response of patients with therapy-resistant depression to theta-burst rTMS treatment. The secondary aim is to monitor the cognitive effects of TMS therapy.
- Being tested
- repetative Transcranial Magnetic Stimulation (rTMS), theta-burst protocol
- Keywords
- TMS, therapy resistant depression, EEG, MRI, neuroimaging
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetative Transcranial Magnetic Stimulation (rTMS), theta-burst protocolDevice
Theta-burst rTMS treatment stimulates the left Dorsolateral Prefrontal Cortex (DLPFC). The TBS parameters the investigators adopted follows the standard TBS protocols, with 3-pulse 50-Hz bursts given every 200 ms (at 5 Hz) and an intensity of 100% active motor threshold. The investigators plan to deliver 1800 stimuli to the left DLPFC daily in 9.5-minute blocks for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| TB-rTMS | Experimental | Not described Receives: Device: repetative Transcranial Magnetic Stimulation (rTMS), theta-burst protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical symptoms
The primary outcome measures are the clinical symptoms of depression measured by a clinician with the Montgomery-Åsberg Depression Rating Scale.
Measured: 120 days
Secondary outcomes (6)
Neuroimaging characteristics
A secondary outcome measure is neuroimaging characteristics including the alpha peaks measured by EEG, the nonoscillatory component (1/f) calculated from resting EEG, and connectivity parameters measured by fMRI. These markers will play a part in response prediction.
Measured: 120 days
Patient profile
The patient profile encompasses demographics and clinical characteristics, namely age, sex, level of education, history of other psychiatric conditions, comorbidities, and medications. Together with neuroimaging characteristics, these will be used for response prediction.
Measured: 120 days
Cognitive functioning/Spatial working Memory
The test will be used measure spatial working memory. Memory span is the major outcome variable of this test (the longest number of elements correctly retraced). Higher values indicate better outcomes. Its minimum value is 0 and it has no theoretical maximum value.
Measured: 120 days
Cognitive functioning/Executive function
The test will be used measure executive functioning. Number of mistakes is the major outcome variable of this test (mistakes arise when subjects fail to differentiate a distractor from the continuous task). Higher values indicate worse outcomes. Its minimum value is 0 and it has no theoretical maximum value.
Time Frame: 120 days
Measured: 120 days
Cognitive functioning/reaction time
The test will be used measure executive functioning and reaction time. Average reaction time is the major outcome variable of this test. Higher values indicate worse outcomes.
Measured: 120 days
Clinical symptoms based on self-report questionnaires
Beck depression inventories are to be used to monitor clinical symptoms of depression
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start13 Jun 2025
- Primary completion13 Jun 2028 (estimated)
- Study completion13 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Magnetic Stimulation, RepetitiveStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gábor Csukly, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207239
- Sponsor's protocol ID
- TMS-DEP-2024
- Acronym
- TMS-DEP-2024
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Theta-burst rTMS Therapy on the Clinical and Cognitive Symptoms of Patients With Therapy Resistant Depression and Response Prediction With Neuroimaging Methods.
- ClinicalTrials.gov ID
- NCT07207239
- Acronym / sponsor ID
- TMS-DEP-2024 / TMS-DEP-2024
- Keywords
- TMS, therapy resistant depression, EEG, MRI, neuroimaging
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 13 Jun 2028 (estimated)
- Study completion
- 13 Jun 2028 (estimated)
- First posted
- 3 Oct 2025 (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.
The primary aim of the study is to find the combination of neuroimaging-related markers, demographics, and clinical characteristics that predict the response of patients with therapy-resistant depression to theta-burst rTMS treatment. The secondary aim is to monitor the cognitive effects of TMS therapy.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TB-rTMS | Experimental | Device: repetative Transcranial Magnetic Stimulation (rTMS), theta-burst protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of depression
- 18 years of age
- Beck depression inventory score above 12 (screening)
- MADRS score above 6 (baseline)
Key exclusion criteria (4 listed)
- serious cognitive impairment
- mental retardation
- history of head injury with loss of consciousness for more than 1 hour
- alcohol or drug abuse within the past 3 months
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 |
|---|---|---|
| repetative Transcranial Magnetic Stimulation (rTMS), theta-burst protocolTheta-burst rTMS treatment stimulates the left Dorsolateral Prefrontal Cortex (DLPFC). The TBS parameters the investigators adopted follows the standard TBS protocols, with 3-pulse 50-Hz bursts given every 200 ms (at 5 Hz) and an intensity of 100% active motor threshold. The investigators plan to deliver 1800 stimuli to the left DLPFC daily in 9.5-minute blocks for four weeks. | Device | TB-rTMS |
Primary outcome
Clinical symptoms
Time frame: 120 days
The primary outcome measures are the clinical symptoms of depression measured by a clinician with the Montgomery-Åsberg Depression Rating Scale.
6 secondary outcomes
Neuroimaging characteristics
Time frame: 120 days
Patient profile
Time frame: 120 days
Cognitive functioning/Spatial working Memory
Time frame: 120 days
Cognitive functioning/Executive function
Time frame: 120 days
Cognitive functioning/reaction time
Time frame: 120 days
Clinical symptoms based on self-report questionnaires
Time frame: 120 days
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 3 Oct 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetative Transcranial Magnetic Stimulation (rTMS), theta-burst protocol in people with Transcranial Magnetic Stimulation, Repetitive and Depression - Major Depressive Disorder, run by Semmelweis University at 1 site in Hungary.
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 4 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 3 Oct 2025. 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 Hungary. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical symptoms (time frame: 120 days). 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 3 Oct 2025.