Transcranial Pulse Stimulation for Depression

Not Applicable

Recruiting

• Conditions: Major Depression

• Registration Number: NCT05551585
• Lead Sponsor: The Hong Kong Polytechnic University

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-09-20
• Study First Posted: 2022-09-22
• Study Start: 2023-06-01
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-29
• Last Update Posted: 2025-07-02
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in depressive symptoms after the treatment	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

Secondary Outcome Measures

Name	Time	Method
Change in depressive symptoms in the follow-up stage	at 3 months follow-up	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.
Change in depressive symptoms	four weeks of treatment and at 3 months follow-up.	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

Trial Locations

Locations (1)

The Hong Kong Polytechnic University; 🇭🇰 Hong Kong, Hong Kong