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Completed

NCT Number: NCT05551585

Transcranial Pulse Stimulation for 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.

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Key information

Conditions

Major Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

MDD group

Inclusion criteria

  • 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.

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.

Treatment and study plan

Transcranial Pulse Stimulation

Device

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,

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in depressive symptoms in the follow-up stage

    Time frame: 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.

  2. Change in depressive symptoms

    Time frame: four weeks of treatment and at 3 months follow-up

    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

  3. Change in depressive symptoms

    Time frame: 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

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

A Randomized, Double-blind, Sham-controlled Clinical Trial of Transcranial Pulse Stimulation for the Treatment of Major Depression

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 22, 2022
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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