Transcranial Pulse Stimulation for Depression

A Randomized, Double-blind, Sham-controlled Clinical Trial of Transcranial Pulse Stimulation for the Treatment of Major Depression

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.

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 exclusion criteria, such as a history of brain surgery, cardiac pacemaker, deep brain stimulation and intracranial metallic particles.