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NCT05551585 | Recruiting | Major Depression

Transcranial Pulse Stimulation for Depression
Sponsor:

The Hong Kong Polytechnic University

Information provided by (Responsible Party):

Dr Georg Kranz

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.

Condition or disease

Major Depression

Intervention/treatment

Transcranial pulse stimulation

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 80 participants
Masking : None (Open Label)
Primary Purpose : Basic Science
Official Title : A Randomized, Double-blind, Sham-controlled Clinical Trial of Transcranial Pulse Stimulation for the Treatment of Major Depression
Actual Study Start Date : June 1, 2023
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025
Arm Intervention/treatment

Experimental: Real TPS treatment group

Participants with MDD will receive TPS treatment lasting for 4 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)

Device: Transcranial pulse stimulation

Sham Comparator: Sham TPS treatment

Participants will receive sham TPS treatment lasting for 4 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),

Device: Transcranial pulse stimulation
Ages Eligible for Study: 18 Years to 60 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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.
    • Transcranial Pulse Stimulation for Depression

    Location Details

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    Transcranial Pulse Stimulation for Depression

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    Recruiting

    Hong Kong,

    The Hong Kong Polytechnic University

    Hong Kong, Hong Kong,