Major DepressionNCT05551585
Transcranial Pulse Stimulation for Depression
A study testing Transcranial pulse stimulation in people with Major Depression, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Transcranial pulse stimulation (TPS) is a newly developed brain stimulation therapy from Austria \& Germany with highly promising applicability in neuropsychiatric disorders. Major depressive disorder (MDD) is the world's leading cause of disability. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depression
- What is being tested?
- Transcranial pulse stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2023to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65;
- A clinical diagnosis of a MDD according to psychiatrist visit records or a clinical interview using the Chinese version of the Mini International Neuropsychiatric Interview (MINI)
- Baseline HAMD17 score ≥ 14;
- Treatment naivety or stable (≥4 weeks) psychopharmacological medication.
Who cannot join
- Severe internal diseases including blood clotting disorders;
- Neurological disorders including bleeding prone micro-pathologies or a history of severe head injuries;
- Current psychiatric comorbidities, including addiction;
- Pregnancy;
- Common NIBS exclusion criteria, such as a history of brain surgery, cardiac pacemaker, deep brain stimulation and intracranial metallic particles.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Sham-controlled Clinical Trial of Transcranial Pulse Stimulation for the Treatment of Major Depression
Transcranial pulse stimulation (TPS) is a newly developed brain stimulation therapy from Austria \& Germany with highly promising applicability in neuropsychiatric disorders. Major depressive disorder (MDD) is the world's leading cause of disability. Novel treatment approaches are urgently needed given that a significant fraction of patients does not sufficiently respond to standard antidepressant treatments. Our open-label pilot study using TPS in MDD indicates preliminary efficacy. However, experimental control is necessary to infer reliable scientific evidence for the efficacy of TPS. Here, we propose a randomized, double-blind, sham-controlled clinical trial to probe the utility of TPS as a modern antidepressant treatment.
- Conditions
- Major Depression
- Being tested
- Transcranial pulse stimulation
- Keywords
- Transcranial pulse stimulation, Brain stimulation, Major depression
- 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.
Transcranial pulse stimulationDevice
TPS will be performed in three treatment sessions per week, applying 1000 pulses per session (single ultrashort (3 μs) ultrasound pulses, 0.2-0.25 mJ mm-2, ~5 Hz pulse frequency,
| Study group | Role | What they receive |
|---|---|---|
| Real TPS treatment group | Experimental | 1. Participants with MDD will receive TPS treatment lasting for 4 weeks (3 sessions per week).
2. A follow-up assessment will be scheduled 3 months after the last REAL treatment day.
3. MRI measurements will be conducted before the start of treatment (within one week before treatment start), as well as after the last treatment day (within one week post-treatment) Receives: Device: Transcranial pulse stimulation |
| Sham TPS treatment | Sham comparator | 1. Participants will receive sham TPS treatment lasting for 4 weeks (3 sessions per week, as done previously.
2. After treatment end and completed assessments, the study will be unblinded and participants in the sham treatment arm will receive real TPS.
3. A follow-up assessment will be scheduled 3 months after the last REAL treatment day.
4. MRI measurements will be conducted before the start of treatment (within one week before treatment start), as well as after the last treatment day (within one week post-treatment), Receives: Device: Transcranial pulse stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptoms after the treatment
Primary clinical outcome measure will be a change in Montgomery-Åsberg Depression Rating Scale (MADRS) score (range from 0-60) after six weeks of treatment. Higher scores indicative of greater depressive symptomology in MADRS
Measured: four weeks of treatment
Secondary outcomes (3)
Change in depressive symptoms in the follow-up stage
Change of Montgomery-Åsberg Depression Rating Scale (MADRS) score (range from 0-60) at 3-months follow-up. Higher scores indicative of greater depressive symptomology in MADRS.
Measured: at 3 months follow-up
Change in depressive symptoms
Change of Hamilton Depression Rating Scale (HAMD17, range from 0-54) scores after four weeks of treatment and at 3-months follow-up. Higher scores indicative of greater depressive symptomology in HAMD-17
Measured: four weeks of treatment and at 3 months follow-up
Change in depressive symptoms
Change of Patient Health Questionnaire (PHQ-9, range from 0-27) scores after four weeks of treatment and at 3-months follow-up. Higher scores indicative of greater depressive symptomology in PHQ-9
Measured: four weeks of treatment and at 3 months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start1 Jun 2023
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Georg Kranz, The Hong Kong Polytechnic University
- Investigators
- Georg S. Kranz, PhD, Principal investigator, The Kong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551585
- Sponsor's protocol ID
- HSEARS20220816001-02
- Status last verified
- Dec 2025
- First submitted
- 14 Sep 2022
- Last updated
- 24 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qin PP, Jin M, Kan RL, Chak I, Zhang BB, Chau W, Li A, Lin TT, Xia AW, Wang SX, Yuan T, Cheung T, Beisteiner R, Sun L, Padberg F, Kranz GS. Prefrontal Transcranial Pulse Stimulation for Major Depressive Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jul 1;9(7):e2621592. doi: 10.1001/jamanetworkopen.2026.21592.
PubMed 42406402
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Sham-controlled Clinical Trial of Transcranial Pulse Stimulation for the Treatment of Major Depression
- ClinicalTrials.gov ID
- NCT05551585
- Acronym / sponsor ID
- HSEARS20220816001-02
- Conditions
- Major Depression
- Keywords
- Transcranial pulse stimulation, Brain stimulation, Major depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 22 Sep 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.
Transcranial pulse stimulation (TPS) is a newly developed brain stimulation therapy from Austria \& Germany with highly promising applicability in neuropsychiatric disorders. Major depressive disorder (MDD) is the world's leading cause of disability. Novel treatment approaches are urgently needed given that a significant fraction of patients does not sufficiently respond to standard antidepressant treatments. Our open-label pilot study using TPS in MDD indicates preliminary efficacy. However, experimental control is necessary to infer reliable scientific evidence for the efficacy of TPS. Here, we propose a randomized, double-blind, sham-controlled clinical trial to probe the utility of TPS as a modern antidepressant treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real TPS treatment group | Experimental | Device: Transcranial pulse stimulation1. Participants with MDD will receive TPS treatment lasting for 4 weeks (3 sessions per week). 2. A follow-up assessment will be scheduled 3 months after the last REAL treatment day. 3. MRI measurements will be conducted before the start of treatment (within one week before treatment start), as well as after the last treatment day (within one week post-treatment) |
| Sham TPS treatment | Sham comparator | Device: Transcranial pulse stimulation1. Participants will receive sham TPS treatment lasting for 4 weeks (3 sessions per week, as done previously. 2. After treatment end and completed assessments, the study will be unblinded and participants in the sham treatment arm will receive real TPS. 3. A follow-up assessment will be scheduled 3 months after the last REAL treatment day. 4. MRI measurements will be conducted before the start of treatment (within one week before treatment start), as well as after the last treatment day (within one week post-treatment), |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 65;
- A clinical diagnosis of a MDD according to psychiatrist visit records or a clinical interview using the Chinese version of the Mini International Neuropsychiatric Interview (MINI)
- Baseline HAMD17 score ≥ 14;
- Treatment naivety or stable (≥4 weeks) psychopharmacological medication.
Key exclusion criteria (5 listed)
- Severe internal diseases including blood clotting disorders;
- Neurological disorders including bleeding prone micro-pathologies or a history of severe head injuries;
- Current psychiatric comorbidities, including addiction;
- Pregnancy;
- Common NIBS exclusion criteria, such as a history of brain surgery, cardiac pacemaker, deep brain stimulation and intracranial metallic particles.
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 |
|---|---|---|
| Transcranial pulse stimulationTPS will be performed in three treatment sessions per week, applying 1000 pulses per session (single ultrashort (3 μs) ultrasound pulses, 0.2-0.25 mJ mm-2, ~5 Hz pulse frequency, | Device | Real TPS treatment group, Sham TPS treatment |
Primary outcome
Change in depressive symptoms after the treatment
Time frame: four weeks of treatment
Primary clinical outcome measure will be a change in Montgomery-Åsberg Depression Rating Scale (MADRS) score (range from 0-60) after six weeks of treatment. Higher scores indicative of greater depressive symptomology in MADRS
3 secondary outcomes
Change in depressive symptoms in the follow-up stage
Time frame: at 3 months follow-up
Change in depressive symptoms
Time frame: four weeks of treatment and at 3 months follow-up
Change in depressive symptoms
Time frame: four weeks of treatment and at 3 months follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Derived from this study: PubMed 42406402Qin PP, Jin M, Kan RL, Chak I, Zhang BB, Chau W, Li A, Lin TT, Xia AW, Wang SX, Yuan T, Cheung T, Beisteiner R, Sun L, Padberg F, Kranz GS. Prefrontal Transcranial Pulse Stimulation for Major Depressive Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jul 1;9(7):e2621592. doi: 10.1001/jamanetworkopen.2026.21592.
- 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. This study is not recruiting at the moment.
Georg S. Kranz, PhD principal investigator
The Kong 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 Transcranial pulse stimulation in people with Major Depression, 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 24 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in depressive symptoms after the treatment (time frame: four weeks of treatment). 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 NCT05551585, which also lists 1 linked publication.
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 24 Dec 2025.