Transcranial Pulse Stimulation for Depression

Last updated: November 9, 2023
Sponsor: The Hong Kong Polytechnic University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression (Major/severe)

Depression (Adult And Geriatric)

Depression

Treatment

Transcranial pulse stimulation

Clinical Study ID

NCT05551585
HSEARS20220816001
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Severe internal diseases including blood clotting disorders;
  • Neurological disorders including bleeding prone micro-pathologies or a history ofsevere 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

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Transcranial pulse stimulation
Phase:
Study Start date:
June 01, 2023
Estimated Completion Date:
January 31, 2025

Connect with a study center

  • The Hong Kong Polytechnic University

    Hong Kong,
    Hong Kong

    Active - Recruiting

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