A Randomized, Double-blind, Sham-controlled Clinical Trial of Transcranial Pulse Stimulation for the Treatment of Major Depression
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• Age 18 to 60;
• A clinical diagnosis of a MDD and a HAMD17 score ≥14;
• Treatment naivety or stable (≥4 weeks) psychopharmacological medication.
Locations
Other Locations
Hong Kong Special Administrative Region
The Hong Kong Polytechnic University
RECRUITING
Hong Kong
Contact Information
Primary
Georg Kranz, PhD
georg.kranz@polyu.edu.hk
27664838
Time Frame
Start Date:2023-06-01
Estimated Completion Date:2025-12-30
Participants
Target number of participants:80
Treatments
Experimental: Real TPS treatment group
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)
Sham_comparator: Sham TPS treatment
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),