Transcranial pulse stimulation for treating major depression
A Randomized, Double-blind, Sham-controlled Clinical Trial of Transcranial Pulse Stimulation for the Treatment of Major Depression
NA · The Hong Kong Polytechnic University · NCT05551585
This study is testing a new brain stimulation treatment to see if it can help people with major depression who haven't found relief from regular antidepressants.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | The Hong Kong Polytechnic University (other) |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05551585 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of transcranial pulse stimulation (TPS), a novel brain stimulation therapy, in treating major depressive disorder (MDD). The study is designed as a randomized, double-blind, sham-controlled trial to ensure scientific rigor and reliability of results. Participants will be monitored for changes in depressive symptoms, with a focus on those who have not responded adequately to standard antidepressant treatments. The trial aims to provide evidence for TPS as a potential modern antidepressant option.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 60 with a clinical diagnosis of major depressive disorder and a HAMD17 score of 14 or higher.
Not a fit: Patients with severe internal diseases, neurological disorders, or current psychiatric comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new, effective option for patients suffering from major depression who do not respond to traditional therapies.
How similar studies have performed: While TPS is a novel approach, preliminary studies have indicated its potential efficacy in treating major depression, suggesting a promising avenue for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
MDD group Inclusion Criteria: * Age 18 to 60; * A clinical diagnosis of a MDD and a HAMD17 score ≥14; * Treatment naivety or stable (≥4 weeks) psychopharmacological medication. Exclusion Criteria: * 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.
Where this trial is running
Hong Kong
- The Hong Kong Polytechnic University — Hong Kong, Hong Kong (RECRUITING)
Study contacts
- Principal investigator: Georg S. Kranz, PhD — The Kong Kong Polytechnic University
- Study coordinator: Georg Kranz, PhD
- Email: georg.kranz@polyu.edu.hk
- Phone: 27664838
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Major Depression, Transcranial pulse stimulation, Brain stimulation, Major depression