Transcranial Pulse Stimulation for Depression

Major Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05551585
• Other study ID #: HSEARS20220816001
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: January 2025

Study information

• Verified date: November 2023
• Source: The Hong Kong Polytechnic University
• Contact: Georg Kranz, PhD
• Phone: 27664838
• Email: georg.kranz[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

MDD group

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Device:
• 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,

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in depressive symptoms in the follow-up stage	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.	at 3 months follow-up
Secondary	Change in depressive symptoms	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	four weeks of treatment and at 3 months follow-up
Secondary	Change in depressive symptoms	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	four weeks of treatment and at 3 months follow-up.