Neuromodulation of Transcranial Pulse Stimulation on Primary Motor Cortex in Adults: A Randomized, Cross-over, Single-blind, Sham-controlled, Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in reaction time in Deary-Liewald reaction time task after TPS
研究概览
简要总结
Transcranial pulse stimulation (TPS) is a newly developed non-invasive brain stimulation (NIBS) technique from Austria & Germany with highly promising applicability in neuropsychiatric disorders. Clinical trials have shown a beneficial effect of TPS in patients with Alzheimer's disease and depression. However, the mechanism of action of TPS treatment is unknown. There is a lack of controlled studies with sufficient sample size to draw reliable conclusions on the modulatory effect of TPS. The primary motor cortex is a common target when investigating the neuromodulation effect of NIBS techniques. Here, a randomized, cross-over, single-blind, sham-controlled clinical trial is proposed to probe the effects of TPS over the primary motor cortex on modulating motor response and motor behavior.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- 是
入选标准
- •Age 18 to 65
- •No physical, neurological or psychiatric disorder
- •Right-handedness
排除标准
- •Background with neuroscience
- •TPS and TMS contraindications, including metal implants, pregnancy, coagulation disorders, thrombosis, brain tumor, cortisone therapy up to 6 weeks before first stimulation, pacemakers or cochlear implants.
研究组 & 干预措施
Real TPS group
- Healthy adults aged 18-65 years old will receive one single session of real TPS on the primary motor cortex.
- Before and after TPS, participants will perform two visuomotor tasks (a simple reaction time task and a nine-hole peg test).
- The stimulation target on the primary motor cortex will be determined by transcranial magnetic stimulation (TMS). Measurements of the resting motor threshold by TMS will be conducted for each participant before the real TPS session.
干预措施: Transcranial pulse stimulation (Device)
Sham TPS group
Sham stimulation comprises TPS on the vertex as the control region (sham control).
Stimulation duration, intensity, as well as pre- and post stimulation assessments are the same as in the experimental arm.
In this cross-over study, the order of the real and sham stimulation conditions will be randomized and separated by 24 hours.
干预措施: Transcranial pulse stimulation (Device)
结局指标
主要结局
Change in reaction time in Deary-Liewald reaction time task after TPS
时间窗: Immediately after the completion of the single session TPS, 10 minutes after the single session TPS, 20 minutes after the single session TPS, 30 minutes after the single session TPS, 40 minutes after the single session TPS
Primary clinical outcome measure will be a change in reaction time in Deary-Liewald reaction time task after TPS. Less reaction time is indicative of greater improvement in motor function.
Change in movement time in nine-hole peg test after TPS
时间窗: Immediately after the completion of the single session TPS, 10 minutes after the single session TPS, 20 minutes after the single session TPS, 30 minutes after the single session TPS, 40 minutes after the single session TPS
Primary clinical outcome measure will be a change in movement time in nine-hole peg test after TPS. Less movement time is indicative of greater improvement in hand dexterity and motor function.
次要结局
- The influence of motor excitability measured by resting motor threshold (RMT) on post-TPS motor performance(30 minutes before TPS session, immediately after the completion of the single session TPS, 10 minutes after the single session TPS, 20 minutes after the single session TPS, 30 minutes after the single session TPS, 40 minutes after the single session TPS)
研究者
Dr Georg Kranz
Principal Investigator
The Hong Kong Polytechnic University