Transcranial Pulse Stimulation for Depression

NCT05551585 | Completed

• 1 other identifier: HSEARS20220816001-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression

Keywords

Transcranial pulse stimulation; Brain stimulation; Major depression

Outcome Measures

Primary Outcomes (1)

• 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

  four weeks of treatment

Secondary Outcomes (3)

• Change in depressive symptoms in the follow-up stage

  at 3 months follow-up

• Change in depressive symptoms

  four weeks of treatment and at 3 months follow-up

• Change in depressive symptoms

  four weeks of treatment and at 3 months follow-up.

Study Arms (2)

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)

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),

Device: Transcranial pulse stimulation

Interventions

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,

Real TPS treatment group; Sham TPS treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Georg S. Kranz, PhD

  The Kong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 22, 2022
• Study Start: June 1, 2023
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)