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Transcranial Pulse Stimulation for Depression

NCT ID: NCT05551585

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-10-30

Brief Summary

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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

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Conditions

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Major Depression

Keywords

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Transcranial pulse stimulation Brain stimulation Major depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Real TPS treatment group

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)

Group Type EXPERIMENTAL

Transcranial pulse stimulation

Intervention Type 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,

Sham TPS treatment

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),

Group Type SHAM_COMPARATOR

Transcranial pulse stimulation

Intervention Type 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,

Interventions

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Transcranial pulse stimulation

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,

Intervention Type DEVICE

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Dr Georg Kranz

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Georg S. Kranz, PhD

Role: PRINCIPAL_INVESTIGATOR

The Kong Kong Polytechnic University

Locations

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The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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HSEARS20220816001-02

Identifier Type: -

Identifier Source: org_study_id