Transcranial Pulse Stimulation for Depression

Not Applicable

Recruiting

• Conditions: Major Depression
• Interventions: Device: Transcranial pulse stimulation

• Registration Number: NCT05551585
• Lead Sponsor: The Hong Kong Polytechnic University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-09-20
• Study First Posted: 2022-09-22
• Study Start: 2023-06-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-09
• Last Update Posted: 2023-11-13
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sham TPS treatment	Transcranial pulse stimulation	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),
Real TPS treatment group	Transcranial pulse stimulation	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)

Primary Outcome Measures

Name	Time	Method
Change in depressive symptoms after the treatment	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 Outcome Measures

Name	Time	Method
Change in depressive symptoms in the follow-up stage	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.
Change in depressive symptoms	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

Trial Locations

Locations (1)

The Hong Kong Polytechnic University; 🇭🇰 Hong Kong, Hong Kong