Major Depression
Conditions
Keywords
Transcranial pulse stimulation, Brain stimulation, Major depression
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.
Interventions
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,
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
MDD group Inclusion Criteria: * Age 18 to 65; * A clinical diagnosis of a MDD according to psychiatrist visit records or a clinical interview using the Chinese version of the Mini International Neuropsychiatric Interview (MINI) * Baseline 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in depressive symptoms after the treatment | four 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
| Measure | Time frame | Description |
|---|---|---|
| Change in depressive symptoms in the follow-up stage | 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 | four weeks of treatment and at 3 months follow-up | Change of Hamilton Depression Rating Scale (HAMD17, range from 0-54) scores after four weeks of treatment and at 3-months follow-up. Higher scores indicative of greater depressive symptomology in HAMD-17 |
Countries
Hong Kong
Outcome results
None listed