Depression, UnipolarNCT06392867
Intermittent Theta-burst Stimulation for Major Depression: an Intensity-response Study
A study testing intermittent theta-burst stimulation (iTBS) in people with Depression, Unipolar, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The United States Food and Drug Administration (FDA) approved intermittent theta-burst stimulation (iTBS) in 2018 as a form of repetitive transcranial magnetic stimulation (rTMS). Hospitals worldwide use it to treat major depressive disorder (MDD). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depression, Unipolar
- 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
- 246 participants
- Where
- 1 siteHong Kong
- Study dates
- 8 Jan 2024to 26 Oct 2026
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are aged between 18 and 70;
- have a MDD diagnosis, single or recurrent episode, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, fifth edition criteria and confirmed by means of the Mini-International Neuropsychiatric Interview (MINI);
- have a score of at least 18 on the 17-item Hamilton Rating Scale for Depression (HDRS17) in their current episode;
- have failed to have a clinically significant response to two or more standard antidepressant treatments during their current episode;
- have received stable psychopharmacological treatment within 4 weeks prior to screening; and
- have normal thyroid function, Complete Blood Count, electrolytes, and liver enzyme levels based on pre-study blood work.
Who cannot join
- have a history of substance abuse or dependence in the past 3 months;
- have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump;
- show active suicidal intent (MADRS item 10 score >4);
- are pregnant;
- have a lifetime MINI diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms;
- have a metal implant or any other common MRI and TMS exclusion criteria;
Show all 9Show fewer
- take antiepileptic drugs or benzodiazepines corresponding to a dose of >1 mg lorazepam per day;
- have had initiation or dose change of any psychotropic medication in the 4 weeks prior to screening or
- have undergone TMS in the past.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong
Georg Kranz, PhD, 2766 ext. 4838, georg.kranz@polyu.edu.hk
About this study
The United States Food and Drug Administration (FDA) approved intermittent theta-burst stimulation (iTBS) in 2018 as a form of repetitive transcranial magnetic stimulation (rTMS). Hospitals worldwide use it to treat major depressive disorder (MDD). It is safe, effective, even for depressed patients unable to respond to standard pharmacological treatment and is more efficient than standard rTMS. In accordance with the approved treatment protocol, patients experience considerable sensory discomfort at a stimulation intensity of 120% of their resting motor threshold (rMT). Antidepressant effects of iTBS are believed to be mediated by modulating prefrontal excitability. There is still a lack of evidence to support the choice of 120% rMT as the optimal stimulation intensity, and the presumed superiority of higher stimulation intensities over lower intensities has yet to be proven. This knowledge gap has clinical implications since more tolerated treatments may lead to greater adherence, resulting in improved outcomes.
The current study proposes a randomized, triple-arm, controlled trial to compare the efficacy of iTBS at 75% (iTBS75) and 120% (iTBS120) rMT with sham iTBS (SiTBS). Based on the following considerations, SiTBS was selected to be compared with iTBS75 and iTBS120: SiTBS will reveal placebo antidepressant effects and serve as a control. iTBS75 is selected because iTBS at 80% aMT exhibits significant excitatory effects on the motor cortex and corresponds to approximately 70% rMT. There is however, a distance of about 12.7mm between the coil and the motor cortex, whereas 14.4mm separates the coil from the dorsolateral prefrontal cortex (DLPFC). Accordingly, a resting motor threshold of 70% at the motor cortex corresponds to a distance-adjusted rMT of 75% at the DLPFC. Lastly, iTBS120 is chosen as the standard stimulation intensity in current iTBS depression trials.
It is our intention to investigate the potential antidepressant effects of iTBS treatment at a much lower stimulation intensity than the one currently employed by most centers in the United States and approved in these centers. Thus, our study can contribute to establishing a treatment regimen with increased adherence and lower withdrawal rates.
Read the detailed description
Introduction:
Key issues and knowledge gaps Intermittent theta-burst stimulation (iTBS), a special form of patterned repetitive transcranial magnetic stimulation (rTMS) approved by the U.S. Food and Drug Administration in 2018, is frequently used in many hospitals worldwide for the treatment of major depressive disorder (MDD). For example, at the Department of Psychiatry and Psychotherapy, Medical University of Vienna, the investigators perform about four iTBS treatments daily, amounting to about 1000 treatments a year. iTBS is safe, effective even in depressed patients that are refractory to standard pharmacological treatments, and has the advantage of increased efficiency over standard rTMS. The approved treatment protocol involves a stimulation intensity of 120% of the individual's resting motor threshold (rMT), an intensity associated with considerable sensory discomfort for patients.
The application of a stimulation intensity of 120% rMT is common practice in many psychiatric TMS clinics, and is based on research with conventional rTMS indicating higher clinical efficacy with higher stimulation intensity . However, neuroplastic effects of iTBS of the motor cortex are generally observed at much lower intensities. Researchers have observed significant excitatory effects of iTBS when the intensity is 80% of active motor threshold (aMT), which is approximately 70% of reactive motor threshold (rMT). Moreover, the assumption that the neuromodulatory effects are greater with increasing stimulation intensity is highly debated, and recent research indicates that a linear dose-response relationship for prefrontal iTBS is unfounded. Yet, modulation of prefrontal excitability is thought to underlie the antidepressant effect of iTBS. The investigators still lack evidence for the choice of 120% rMT as the optimal intensity and the presumed superiority of higher stimulation strengths over lower intensities is yet to be investigated. This is a knowledge gap that has important clinical implications because more tolerable treatments could result in greater adherence, and therefore ultimately better outcomes.
Here, the investigators propose a randomized, multicentre, triple-arm, controlled clinical trial to compare the efficacy of a 4-week treatment of daily iTBS at 75% (iTBS75) and 120% (iTBS120) rMT compared to sham iTBS (SiTBS). The choice to compare SiTBS with iTBS75 and iTBS120 is based on the following considerations: SiTBS will reveal placebo antidepressant effects and serves as a control condition. iTBS75 is chosen because iTBS at 80% aMT shows significant excitatory effects of the motor cortex and equals approximately 70% rMT. However, the distance from the coil to the motor cortex is on average 12.7mm whereas the distance to the dorsolateral prefrontal cortex (DLPFC) is about 14.4 mm. Hence, a resting motor threshold of 70% at the motor cortex corresponds to a distance-adjusted rMT of approximately 75% at the DLPFC. Finally, iTBS120 is chosen as it is the standard stimulation intensity in current iTBS trials for depression.
Our proposed study will elucidate the potential antidepressant effect of iTBS treatment at a much lower stimulation intensity than that currently employed by most centres and approved in the U.S. Hence, our study has a high potential to pave the way towards establishing a treatment regimen with increased adherence and lower rates of withdrawal.
Aims and Hypotheses to be tested:
This randomized, multicentre, triple-arm, controlled clinical trial aims to compare the efficacy of SiTBS with iTBS75 and iTBS120 after four weeks of daily treatments in patients with MDD. The investigators hypothesize that iTBS75 will be more effective in reducing depressive symptoms compared with SiTBS and iTBS120. More specifically, (1) the investigators hypothesize that the rate of response, defined as a reduction of Montgomery-Asberg Depression Rating Scale (MADRS) score to ≤50% of baseline values after treatment is significantly higher for iTBS75, compared to sham stimulation and iTBS120 (primary hypothesis). In a secondary analysis, the investigators will test the hypothesis that (2) the rate of remission, defined as a final MADRS score of ≤8, over the course of four weeks of treatment is significantly higher for iTBS75, compared to the other two arms. Similarly, the investigators hypothesise that the increase of (3) subjective mood and (4) happiness, assessed using PHQ-9 and SHS, respectively, is significantly higher for iTBS75, compared to the other two arms. Finally, the investigators hypothesize that (5) iTBS75 is more tolerable than iTBS120, as indicated by a lower reported pain sensation during iTBS75 compared to iTBS120.
- Conditions
- Depression, Unipolar
- Being tested
- intermittent theta-burst stimulation (iTBS)
- Keywords
- Transcranial magnetic stimulation, TMS, Major Depressive Disorder, iTBS, TMS treatment for depression
- Medical subject headings
- Depressive Disorder, 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
iTBS treatment will be performed as comprising 3-pulse 50-Hz bursts, applied every 200 ms (at 5 Hz). iTBS consists of 2-second trains with an inter-train-interval of 8 seconds. Repeat trains (30 pulses; 10 bursts) 20 times to reach a total number of 600 pulses (3x10x20) which equals the standard number of pulses in a daily iTBS treatment session, as approved by the FDA. The stimulation site over the left DLPFC will be determined using the international 10-20 system for EEG electrodes corresponding to the F3 location. 20 daily treatment sessions will be performed from Mondays to Fridays for four weeks for all included patients.
Treatments will be performed at the brain stimulation laboratory at the Hong Kong Polytechnic University. Stimulation will be delivered using a MagPro X100 model (details about MagPro X100: magventure.com/en_eur/products/magpro-x100/ ) and a Cool-B65 A/P Butterfly Coil is used in this study.
| Study group | Role | What they receive |
|---|---|---|
| SiTBS | Sham comparator | The participants will not receive any benefit from the intermittent theta-burst stimulation (iTBS) if they use the inactive side of the coil. Receives: Device: intermittent theta-burst stimulation (iTBS) |
| iTBS75 | Active comparator | The intensity of intermittent theta-burst stimulation (iTBS) applied to the participant will be 75% of their individual rest motor threshold (rMT). Receives: Device: intermittent theta-burst stimulation (iTBS) |
| iTBS120 | Active comparator | The intensity of intermittent theta-burst stimulation (iTBS) applied to the participant will be 120% of their individual rest motor threshold (rMT). Receives: Device: intermittent theta-burst stimulation (iTBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg depression rating scale (MADRS)
The Montgomery-Åsberg Depression Rating Scale is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Response rate after treatment (Montgomery-Asberg depression rating scale, MADRS reduction ≥50% of baseline)
0 to 6: normal /symptom absent. 7 to 19: mild depression. 20 to 34: moderate depression. 35 to 60: severe depression.
Measured: through study completion, an average of 1 month
Secondary outcomes (3)
Patient Health Questionnaire-9 (PHQ-9)
The nine-item Patient Health Questionnaire is a depressive symptom scale
PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.
Measured: through study completion, an average of 1 month
Subjective Happiness Scale (SHS)
The Subjective Happiness Scale seeks to conduct a global, subjective assessment of whether a person is happy or unhappy.
A final score of subjective happiness is calculated by averaging the responses to the four items, with the 4th item's response being reverse coded (i.e., 7 turns to a 1, 6 turns to a 2, etc.). The final scores range from 1.0 to 7.0. Higher scores reflect greater subjective happiness.
Measured: through study completion, an average of 1 month
Verbal Analogue Scale (VAS) Pain level
To ensure tolerability, the stimulation intensity will be adaptively titrated upward during the initial sessions of treatment to the target intensity without exceeding pain levels of 7, rated on a verbal analogue scale (VAS) ranging from 0 (no pain) to 10 (intolerable pain).
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start8 Jan 2024
- Primary completion26 Apr 2026 (estimated)
- Study completion26 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, UnipolarStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with Major Depressive Disorder will undergo daily intermittent theta-burst stimulation (iTBS) at left DLPFC, 20 sessions in 4 weeks. It is to investigate the potential antidepressant effects of iTBS treatment at a much lower stimulation intensity than the one currently employed by most centers in the United States and approved in these centers. The current study proposes a randomized, triple-arm, controlled trial to compare the efficacy of iTBS at 75% (iTBS75) and 120% (iTBS120) rMT with sham iTBS (SiTBS). Based on the following considerations, SiTBS was selected to be compared with iTBS75 and iTBS120: SiTBS will reveal placebo antidepressant effects and serve as a control.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Health and Medical Research Fund
- Responsible party
- Principal investigator, Dr Georg Kranz, The Hong Kong Polytechnic University
- Investigators
- Georg Kranz, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392867
- Sponsor's protocol ID
- HSEARS20221101008
- Status last verified
- Mar 2025
- First submitted
- 23 Apr 2024
- Last updated
- 14 Mar 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 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Theta-burst Stimulation for Major Depression: an Intensity-response Study
- ClinicalTrials.gov ID
- NCT06392867
- Acronym / sponsor ID
- HSEARS20221101008
- Conditions
- Depression, Unipolar
- Keywords
- Transcranial magnetic stimulation, TMS, Major Depressive Disorder, iTBS, TMS treatment for depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Health and Medical Research Fund
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 26 Apr 2026 (estimated)
- Study completion
- 26 Oct 2026 (estimated)
- First posted
- 1 May 2024 (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 United States Food and Drug Administration (FDA) approved intermittent theta-burst stimulation (iTBS) in 2018 as a form of repetitive transcranial magnetic stimulation (rTMS). Hospitals worldwide use it to treat major depressive disorder (MDD). It is safe, effective, even for depressed patients unable to respond to standard pharmacological treatment and is more efficient than standard rTMS. In accordance with the approved treatment protocol, patients experience considerable sensory discomfort at a stimulation intensity of 120% of their resting motor threshold (rMT). Antidepressant effects of iTBS are believed to be mediated by modulating prefrontal excitability. There is still a lack of evidence to support the choice of 120% rMT as the optimal stimulation intensity, and the presumed superiority of higher stimulation intensities over lower intensities has yet to be proven. This knowledge gap has clinical implications since more tolerated treatments may lead to greater adherence, resulting in improved outcomes.
The current study proposes a randomized, triple-arm, controlled trial to compare the efficacy of iTBS at 75% (iTBS75) and 120% (iTBS120) rMT with sham iTBS (SiTBS). Based on the following considerations, SiTBS was selected to be compared with iTBS75 and iTBS120: SiTBS will reveal placebo antidepressant effects and serve as a control. iTBS75 is selected because iTBS at 80% aMT exhibits significant excitatory effects on the motor cortex and corresponds to approximately 70% rMT. There is however, a distance of about 12.7mm between the coil and the motor cortex, whereas 14.4mm separates the coil from the dorsolateral prefrontal cortex (DLPFC). Accordingly, a resting motor threshold of 70% at the motor cortex corresponds to a distance-adjusted rMT of 75% at the DLPFC. Lastly, iTBS120 is chosen as the standard stimulation intensity in current iTBS depression trials.
It is our intention to investigate the potential antidepressant effects of iTBS treatment at a much lower stimulation intensity than the one currently employed by most centers in the United States and approved in these centers. Thus, our study can contribute to establishing a treatment regimen with increased adherence and lower withdrawal rates.
Detailed description
Introduction:
Key issues and knowledge gaps Intermittent theta-burst stimulation (iTBS), a special form of patterned repetitive transcranial magnetic stimulation (rTMS) approved by the U.S. Food and Drug Administration in 2018, is frequently used in many hospitals worldwide for the treatment of major depressive disorder (MDD). For example, at the Department of Psychiatry and Psychotherapy, Medical University of Vienna, the investigators perform about four iTBS treatments daily, amounting to about 1000 treatments a year. iTBS is safe, effective even in depressed patients that are refractory to standard pharmacological treatments, and has the advantage of increased efficiency over standard rTMS. The approved treatment protocol involves a stimulation intensity of 120% of the individual's resting motor threshold (rMT), an intensity associated with considerable sensory discomfort for patients.
The application of a stimulation intensity of 120% rMT is common practice in many psychiatric TMS clinics, and is based on research with conventional rTMS indicating higher clinical efficacy with higher stimulation intensity . However, neuroplastic effects of iTBS of the motor cortex are generally observed at much lower intensities. Researchers have observed significant excitatory effects of iTBS when the intensity is 80% of active motor threshold (aMT), which is approximately 70% of reactive motor threshold (rMT). Moreover, the assumption that the neuromodulatory effects are greater with increasing stimulation intensity is highly debated, and recent research indicates that a linear dose-response relationship for prefrontal iTBS is unfounded. Yet, modulation of prefrontal excitability is thought to underlie the antidepressant effect of iTBS. The investigators still lack evidence for the choice of 120% rMT as the optimal intensity and the presumed superiority of higher stimulation strengths over lower intensities is yet to be investigated. This is a knowledge gap that has important clinical implications because more tolerable treatments could result in greater adherence, and therefore ultimately better outcomes.
Here, the investigators propose a randomized, multicentre, triple-arm, controlled clinical trial to compare the efficacy of a 4-week treatment of daily iTBS at 75% (iTBS75) and 120% (iTBS120) rMT compared to sham iTBS (SiTBS). The choice to compare SiTBS with iTBS75 and iTBS120 is based on the following considerations: SiTBS will reveal placebo antidepressant effects and serves as a control condition. iTBS75 is chosen because iTBS at 80% aMT shows significant excitatory effects of the motor cortex and equals approximately 70% rMT. However, the distance from the coil to the motor cortex is on average 12.7mm whereas the distance to the dorsolateral prefrontal cortex (DLPFC) is about 14.4 mm. Hence, a resting motor threshold of 70% at the motor cortex corresponds to a distance-adjusted rMT of approximately 75% at the DLPFC. Finally, iTBS120 is chosen as it is the standard stimulation intensity in current iTBS trials for depression.
Our proposed study will elucidate the potential antidepressant effect of iTBS treatment at a much lower stimulation intensity than that currently employed by most centres and approved in the U.S. Hence, our study has a high potential to pave the way towards establishing a treatment regimen with increased adherence and lower rates of withdrawal.
Aims and Hypotheses to be tested:
This randomized, multicentre, triple-arm, controlled clinical trial aims to compare the efficacy of SiTBS with iTBS75 and iTBS120 after four weeks of daily treatments in patients with MDD. The investigators hypothesize that iTBS75 will be more effective in reducing depressive symptoms compared with SiTBS and iTBS120. More specifically, (1) the investigators hypothesize that the rate of response, defined as a reduction of Montgomery-Asberg Depression Rating Scale (MADRS) score to ≤50% of baseline values after treatment is significantly higher for iTBS75, compared to sham stimulation and iTBS120 (primary hypothesis). In a secondary analysis, the investigators will test the hypothesis that (2) the rate of remission, defined as a final MADRS score of ≤8, over the course of four weeks of treatment is significantly higher for iTBS75, compared to the other two arms. Similarly, the investigators hypothesise that the increase of (3) subjective mood and (4) happiness, assessed using PHQ-9 and SHS, respectively, is significantly higher for iTBS75, compared to the other two arms. Finally, the investigators hypothesize that (5) iTBS75 is more tolerable than iTBS120, as indicated by a lower reported pain sensation during iTBS75 compared to iTBS120.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients with Major Depressive Disorder will undergo daily intermittent theta-burst stimulation (iTBS) at left DLPFC, 20 sessions in 4 weeks. It is to investigate the potential antidepressant effects of iTBS treatment at a much lower stimulation intensity than the one currently employed by most centers in the United States and approved in these centers. The current study proposes a randomized, triple-arm, controlled trial to compare the efficacy of iTBS at 75% (iTBS75) and 120% (iTBS120) rMT with sham iTBS (SiTBS). Based on the following considerations, SiTBS was selected to be compared with iTBS75 and iTBS120: SiTBS will reveal placebo antidepressant effects and serve as a control.
| Arm | Type | Receives |
|---|---|---|
| SiTBS | Sham comparator | Device: intermittent theta-burst stimulation (iTBS)The participants will not receive any benefit from the intermittent theta-burst stimulation (iTBS) if they use the inactive side of the coil. |
| iTBS75 | Active comparator | Device: intermittent theta-burst stimulation (iTBS)The intensity of intermittent theta-burst stimulation (iTBS) applied to the participant will be 75% of their individual rest motor threshold (rMT). |
| iTBS120 | Active comparator | Device: intermittent theta-burst stimulation (iTBS)The intensity of intermittent theta-burst stimulation (iTBS) applied to the participant will be 120% of their individual rest motor threshold (rMT). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- are aged between 18 and 70;
- have a MDD diagnosis, single or recurrent episode, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, fifth edition criteria and confirmed by means of the Mini-International Neuropsychiatric Interview (MINI);
- have a score of at least 18 on the 17-item Hamilton Rating Scale for Depression (HDRS17) in their current episode;
- have failed to have a clinically significant response to two or more standard antidepressant treatments during their current episode;
- have received stable psychopharmacological treatment within 4 weeks prior to screening; and
Key exclusion criteria (9 listed)
- have a history of substance abuse or dependence in the past 3 months;
- have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump;
- show active suicidal intent (MADRS item 10 score >4);
- are pregnant;
- have a lifetime MINI diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms;
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)iTBS treatment will be performed as comprising 3-pulse 50-Hz bursts, applied every 200 ms (at 5 Hz). iTBS consists of 2-second trains with an inter-train-interval of 8 seconds. Repeat trains (30 pulses; 10 bursts) 20 times to reach a total number of 600 pulses (3x10x20) which equals the standard number of pulses in a daily iTBS treatment session, as approved by the FDA. The stimulation site over the left DLPFC will be determined using the international 10-20 system for EEG electrodes corresponding to the F3 location. 20 daily treatment sessions will be performed from Mondays to Fridays for four weeks for all included patients. Treatments will be performed at the brain stimulation laboratory at the Hong Kong Polytechnic University. Stimulation will be delivered using a MagPro X100 model (details about MagPro X100: magventure.com/en_eur/products/magpro-x100/ ) and a Cool-B65 A/P Butterfly Coil is used in this study. | Device | SiTBS, iTBS120, iTBS75 |
Primary outcome
Montgomery-Asberg depression rating scale (MADRS)
Time frame: through study completion, an average of 1 month
The Montgomery-Åsberg Depression Rating Scale is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Response rate after treatment (Montgomery-Asberg depression rating scale, MADRS reduction ≥50% of baseline) 0 to 6: normal /symptom absent. 7 to 19: mild depression. 20 to 34: moderate depression. 35 to 60: severe depression.
3 secondary outcomes
Patient Health Questionnaire-9 (PHQ-9)
Time frame: through study completion, an average of 1 month
Subjective Happiness Scale (SHS)
Time frame: through study completion, an average of 1 month
Verbal Analogue Scale (VAS) Pain level
Time frame: through study completion, an average of 1 month
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 14 Mar 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.
Georg Kranz, PhD principal investigator
The Hong Kong Polytechnic University
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 Depression, Unipolar, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 9 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 14 Mar 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 Hong Kong. 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?
Contact Georg Kranz, PhD (27664838, georg.kranz@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Asberg depression rating scale (MADRS) (time frame: through study completion, an average of 1 month). 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 14 Mar 2025.