NCT05551585Completed
Transcranial Pulse Stimulation for Depression
A Randomized, Double-blind, Sham-controlled Clinical Trial of Transcranial Pulse Stimulation for the Treatment of Major Depression
Source: ClinicalTrials.gov · Last updated 24 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 14 Sept 2022
- Start date
- 1 Jun 2023
- Primary completion date
- 30 Oct 2025
- Lead sponsor
- The Hong Kong Polytechnic University
- Diseases
- Depression
- NCT number
- NCT05551585
What you commit to
- Study type: Interventional
- Participants enrolled: 80
- From 1 Jun 2023 to the primary completion date, 30 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
- Common NIBS exclusion criteria, such as a history of brain surgery, cardiac pacemaker, deep brain stimulation and intracranial metallic particles.
Other
- Pregnancy;
Who the study is looking for
- 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.
Criteria the registry did not label
- MDD group
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Hong Kong Polytechnic University Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
Related publications
- Prefrontal Transcranial Pulse Stimulation for Major Depressive Disorder: A Randomized Clinical Trial.JAMA Netw Open · 2026 · PMID 42406402
This page is information, not medical advice. Discuss any trial with your doctor.