Transcranial Pulse Stimulation for Depression

Overview

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.

Full Title of Study: “A Randomized, Double-blind, Sham-controlled Clinical Trial of Transcranial Pulse Stimulation for the Treatment of Major Depression”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2025

Interventions

  • 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,

Arms, Groups and Cohorts

  • Experimental: Real TPS treatment group
    • Participants with MDD will receive TPS treatment lasting for 6 weeks (3 sessions per week). A follow-up assessment will be scheduled 3 months after the last REAL treatment day. 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)
  • Sham Comparator: Sham TPS treatment
    • Participants will receive sham TPS treatment lasting for 6 weeks (3 sessions per week, as done previously. After treatment end and completed assessments, the study will be unblinded and participants in the sham treatment arm will receive real TPS. A follow-up assessment will be scheduled 3 months after the last REAL treatment day. 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),

Clinical Trial Outcome Measures

Primary Measures

  • Change in depressive symptoms after the treatment
    • Time Frame: six 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 Measures

  • Change in depressive symptoms in the follow-up stage
    • Time Frame: 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
    • Time Frame: six weeks of treatment and at 3 months follow-up
    • Change of Hamilton Depression Rating Scale (HAMD17, range from 0-54) scores after six weeks of treatment and at 3-months follow-up. Higher scores indicative of greater depressive symptomology in HAMD-17
  • Change in depressive symptoms
    • Time Frame: six weeks of treatment and at 3 months follow-up.
    • Change of Patient Health Questionnaire (PHQ-9, range from 0-27) scores after six weeks of treatment and at 3-months follow-up. Higher scores indicative of greater depressive symptomology in PHQ-9

Participating in This Clinical Trial

MDD group Inclusion Criteria:

  • Age 18 to 60; – A clinical diagnosis of a MDD according to results of the Mini International Neuropsychiatric Interview (MINI) and a HAMD17 score ≥18; – 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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Hong Kong Polytechnic University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr Georg Kranz, Assistant Professor – The Hong Kong Polytechnic University
  • Overall Official(s)
    • Georg S. Kranz, PhD, Principal Investigator, The Kong Kong Polytechnic University
  • Overall Contact(s)
    • Georg Kranz, PhD, 27664838, georg.kranz@polyu.edu.hk

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