EffectsOfTranscranialPulseStimulationOnDepression-PilotRCT (TPS)

March 11, 2025 updated by: The Hong Kong Polytechnic University

Effects of Transcranial Pulse Stimulation (TPS) on Young Adults with Symptoms of Depression - a Pilot Randomized Controlled Trial

The aim of this study is to evaluate the effects of transranial pulse stimulation (TPS) on young adults with symptoms of depression in Hong Kong. Methods: This is a single-blind randomized controlled trial design with two-armed repeated measures, and participants will be followed up at a 3-months post-stimulation period. Eligbility: 1) aged 18 or over; 2) able to understand/read Chinese; 3) HAM-D-17 score of ≥ 8; 4) provide written informed consent. Exclusion criteria includes: 1) individuals being prescribed a DSM-5 diagnosis other than major depressive disorder (e.g., bipolar affective disorder or schizophrenia); 2) Alcohol or substance dependence; 3) Concomitant unstable major medical conditions or major neurological conditions such as brain tumour, brain aneurysm; 4) Haemophilia or other blood clotting disorders or thrombosis; 5) Significant communicative impairments; 6) Participants with metal implant in brain or treated area of the head; 7) Participants who undertook corticosteroid treatment within the last six weeks before first TPS treatment; 8) Pregnant or breastfeeding women. Recruitment: A total of 30 subjects will be recruited from collaborative NGOs and PolyU and randomly assigned into the Intervention Group (TPS) and the Waitlist Control Group on a 1: 1 ratio. Intervention: All participants (both TPS group and the waitlist control group) will receive six 30 minute-TPS sessions (300 pulse in each session, total: 1800 pulse) in 2 weeks' time. Outcome measurements include depression, anhedonia, instrumental activities of daily living, cognition and neuroimaging.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. PRIMARY OBJECTIVE: To evaluate the effects of Transcranial Pulse Stimulation (TPS) on symptoms of depression among young adults in Hong Kong.

    SECONDARY OBJECTIVES:

  2. To improve young adults' Anhedonia symptoms after the 2-week TPS intervention and will be maintained at 3-month post-intervention follow-up
  3. To improve young adults' Instrumental Activities of Daily Living (IADL) after the 2-week TPS intervention and will be maintained at 3-month post-intervention follow-up.
  4. To improve young adults' Cognition after the 2-week TPS intervention and will be maintained at 3-month post-intervention follow-up.
  5. Post-MRI scan will show a remarkable structural and functional connectivity in participants' brain after the 2-week TPS intervention compared to pre-MRI scan.

Sample size estimation: To the best of investigator's knowledge, there is only one TPS uncontrolled pilot study conducted on 35 patients with AD in Austria and therefore, we cannot base on their effect size to estimate our sample size in this study. Considering the nature of this study is the first pilot RCT in using TPS in the treatment of depression,investigators aim at recruiting 30 subjects to evaluate the efficacy of our primary and secondary outcomes in this study.

Research plan and Methodology Methods Trial Design: In this study, the investigators will use a single-blind randomized controlled trial design with two-armed repeated measures. The trial design complies with the Consolidated Standards of Reporting Trials (CONSORT) statement. In this two-armed design, investigators will use TPS as an intervention group and a waitlist control group. A waitlist control group is appropriate for comparing the effect of the TPS on the intervention group to that of those not receiving the TPS treatment at the same timepoints Both groups will be measured at baseline (T1), immediately after the intervention (T2) and at the 3-month follow-up (T3). Based on the previous studies, a 3-month follow-up is sufficient to assess the long-term sustainability of the TPS intervention.

Intervention (Transcranial Pulse Stimulation) Purpose of the intervention: The key tenets of the TPS intervention is neuromodulation, i.e., using ultrasound-based brain stimulation techniques to modulate the human brain in a focal and targeted manner. Intervention dose: Each participant should have the pre-treatment MRI scan performed in the University Research Facility in Behavioural and Systems Neuroscience, PolyU prior coming to the first intervention session. All participants (both TPS group and the waitlist control group) will receive six 30 minute-TPS sessions (300 pulse in each session, total: 1800 pulse) in 2 weeks' time (i.e., 3 sessions (Monday, Wednesday, Friday) per week, total: 3 hours). Participants will be followed up at 3-month period after the intervention (Fig 1). The investigators believe that a 2-week TPS intervention is sufficient enough to test the effects of TPS on depressive symptoms.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • HongKong, Hong Kong
        • School of Nursing HongKongPolyU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 18 or over
  • Able to understand/read Chinese
  • A HAM-D-17 score of ≥ 8
  • Able to provide written informed consent

Exclusion Criteria:

  • Clinical Diagnosis of Major Depressive Disorder (e.g., bipolar affective disorder or schizophrenia)
  • Alcohol or substance dependence
  • Concomitant unstable major medical conditions or major neurological conditions such as brain tumor, brain aneurysm
  • Hemophilia or other blood clotting disorders or thrombosis
  • Significant communicative impairments
  • Participants with metal implant in brain or treated area of the head
  • Participants who undertook corticosteroid treatment within the last six weeks before first TPS treatment
  • Pregnant or breastfeeding women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcranial Pulse Stimulation
Investigators will use a single-blind randomized controlled trial design with two-armed repeated measures. The trial design complies with the Consolidated Standards of Reporting Trials (CONSORT) statement. The first arm is the Intervention Group (Transcranial Pulse Stimulation) (TPS group)
Device: Transcranial Pulse Stimulation
A total of 30 participants (both TPS group and the waitlist control group) will receive six 30 minute-TPS sessions (300 pulse in each session, total: 1800 pulse) in 2 weeks' time (i.e., 3 sessions (Monday, Wednesday, Friday) per week, total: 3 hours), on a 1: 1 allocation ratio. Participants will be followed up at 3-month period after the intervention. A 2-week TPS intervention alongside with 3-month follow-up is sufficient enough to test the effects of TPS on depressive symptoms.
Active Comparator: Waitlist Control Group
Second arm is the waitlist control group.
Device: Transcranial Pulse Stimulation
A total of 30 participants (both TPS group and the waitlist control group) will receive six 30 minute-TPS sessions (300 pulse in each session, total: 1800 pulse) in 2 weeks' time (i.e., 3 sessions (Monday, Wednesday, Friday) per week, total: 3 hours), on a 1: 1 allocation ratio. Participants will be followed up at 3-month period after the intervention. A 2-week TPS intervention alongside with 3-month follow-up is sufficient enough to test the effects of TPS on depressive symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: Participants will be measured the changes of HAM-D-17 scores at baseline, immediately after intervention and at 3-months follow-up
Hamilton Depression Rating Scale 17 (HAM-D-17) is a widely used reliable measurement. Scores range from 0 and 52, with higher scores indicating more severe depression.
Participants will be measured the changes of HAM-D-17 scores at baseline, immediately after intervention and at 3-months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anhedonia
Time Frame: Participants will be measured the changes of SHAPS score at baseline, immediately after intervention and at 3-months follow-up
The core symptom of depression will be assessed by the Chinese version of the Snaith-Hamilton Pleasure Scale (SHAPS). SHAPS is a self-report scale containing 14 items. Each item scores from 1 to 4. Total scores range from 14 to 56. A higher total SHAPS score indicates lower level of anhedonia.
Participants will be measured the changes of SHAPS score at baseline, immediately after intervention and at 3-months follow-up
Instrumental Activities of Daily Living (IADL)
Time Frame: Participants will be measured the changes of IADL score at baseline, immediately after intervention and at 3-months follow-up
IADL will be assessed by the 8-item Hong Kong Chinese version of the Lawton Instrumental Activities of Daily Living Scale. Each item scores from 0 or 1. Total score ranges from 0-8. A lower score indicates a higher level of dependence.
Participants will be measured the changes of IADL score at baseline, immediately after intervention and at 3-months follow-up
Cognition
Time Frame: Participants will be measured the changes of the MoCA scores at baseline, immediately after intervention and at 3-months follow-up
Global cognition will be measured using the Hong Kong Chinese version of the Montreal Cognitive Assessment (MoCA). Montreal Cognitive Assessment is a 30-point scale, with points awarded differently depending on the type of question asked. A score between 26 to 30 indicate normal cognitive abilities. A score of 19 to 25 indicates mild cognitive impairment. Scores of between 11 and 21 suggest mild Alzheimer's disease.
Participants will be measured the changes of the MoCA scores at baseline, immediately after intervention and at 3-months follow-up
Neuroimaging
Time Frame: Participants will be measured the changes at baseline, immediately after intervention and at 3-months follow-up
Participants will receive pre and post treatment MRI scan to measure any changes in structural and functional connectivity changes in the brain.
Participants will be measured the changes at baseline, immediately after intervention and at 3-months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Teris Cheung, PhD, HongKongPolyU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2021

Primary Completion (Actual)

May 31, 2022

Study Completion (Actual)

January 28, 2023

Study Registration Dates

First Submitted

August 3, 2021

First Submitted That Met QC Criteria

August 8, 2021

First Posted (Actual)

August 16, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HongKongPU_HSEARS20210608002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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