Back to resultsTranscranial Pulse Stimulation for Depression
Primary Purpose
Major Depression
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Transcranial pulse stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Major Depression focused on measuring Transcranial pulse stimulation, Brain stimulation, Major depression
Eligibility Criteria
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.
Sites / Locations
- The Hong Kong Polytechnic UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Real TPS treatment group
Sham TPS treatment
Arm Description
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)
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),
Outcomes
Primary Outcome Measures
Change in depressive symptoms after the 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
Change in depressive symptoms in the follow-up stage
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
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
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
Full Information
NCT ID
NCT05551585
First Posted
September 14, 2022
Last Updated
September 20, 2023
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT05551585
Brief Title
Transcranial Pulse Stimulation for Depression
Official Title
A Randomized, Double-blind, Sham-controlled Clinical Trial of Transcranial Pulse Stimulation for the Treatment of Major Depression
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
Transcranial pulse stimulation, Brain stimulation, Major depression
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Real TPS treatment group
Arm Type
Experimental
Arm Description
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)
Arm Title
Sham TPS treatment
Arm Type
Sham Comparator
Arm Description
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),
Intervention Type
Device
Intervention Name(s)
Transcranial pulse stimulation
Intervention Description
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,
Primary Outcome Measure Information:
Title
Change in depressive symptoms after the treatment
Description
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
Time Frame
six weeks of treatment
Secondary Outcome Measure Information:
Title
Change in depressive symptoms in the follow-up stage
Description
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.
Time Frame
at 3 months follow-up
Title
Change in depressive symptoms
Description
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
Time Frame
six weeks of treatment and at 3 months follow-up
Title
Change in depressive symptoms
Description
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
Time Frame
six weeks of treatment and at 3 months follow-up.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Georg Kranz, PhD
Phone
27664838
Email
georg.kranz@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg S. Kranz, PhD
Organizational Affiliation
The Kong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georg S Kranz, PhD
Phone
2766
Ext
4838
Email
georg.kranz@polyu.edu.hk
12. IPD Sharing Statement
Plan to Share IPD
No
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Transcranial Pulse Stimulation for Depression
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