Transcranial Pulse Stimulation for Depression

The Hong Kong Polytechnic University

Status: Completed

Conditions: Major Depression

Treatments: Device: Transcranial pulse stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05551585

HSEARS20220816001-02

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

80 participants in 2 patient groups

Real TPS treatment group

Experimental group

Description:

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)

Treatment:

Device: Transcranial pulse stimulation

Sham TPS treatment

Sham Comparator group

Description:

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),

Treatment:

Device: Transcranial pulse stimulation