A Randomized, Double-blind, Sham-controlled Clinical Trial of Transcranial Pulse Stimulation for the Treatment of Major Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in depressive symptoms after the treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Real TPS treatment group
- Participants with MDD will receive TPS treatment lasting for 4 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)
干预措施: Transcranial pulse stimulation (Device)
Sham TPS treatment
- Participants will receive sham TPS treatment lasting for 4 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),
干预措施: Transcranial pulse stimulation (Device)
结局指标
主要结局
Change in depressive symptoms after the treatment
时间窗: 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
次要结局
- Change in depressive symptoms in the follow-up stage(at 3 months follow-up)
- Change in depressive symptoms(four weeks of treatment and at 3 months follow-up.)
- Change in depressive symptoms(four weeks of treatment and at 3 months follow-up)
研究者
Dr Georg Kranz
Assistant Professor
The Hong Kong Polytechnic University