The Trans-cutaneous Effects on Physiological Tremor Entertainment During tACS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in tremor-stimulation phase entrainment- Session 1
研究概览
简要总结
Transcranial alternating current stimulation (tACS) is a noninvasive neuromodulation method that works by passing alternating electric current between electrodes where at least one of them is attached to the head. This has been shown to have effects on the motor system, cognition and behavior. The exact mechanism by which tACS causes such effects is not fully understood. Some studies suggests a contribution from the stimulated peripheral nerves present in the scalp rather than direct brain effects. To test this hypothesis two arms will be done. First, 12 subjects (arm 1) will be stimulated using focused 4x1 montage with gel-filled cup-electrodes over the motor cortex and the effects will be compared between anesthetized and non-anesthetized scalp. The effects of anesthetizing the scalp will be tested on three different stimulation amplitudes off (0 mA), low (0.5 mA) and high (2.5 mA). Then, 10 subjects (arm 2) will be stimulated over the contralateral arm to exclude any direct brain stimulation effects and to test if peripheral nerve stimulation can entrain the tremor. Three outcome measurements will be measured during the experiments which are: tremor entrainment, sensation intensity and sensation threshold.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consents
排除标准
- •Pregnancy
- •History of Epilepsy
- •Family history of Epilepsy
研究组 & 干预措施
Head stimulation
Each subject will be stimulated at two different days. One day with the presence of topical anesthetic cream on the scalp above the MC and in the other day with absence of the anesthetic cream. Stimulation frequency is set similar to that of the tremor. Three stimulation amplitudes will be tested (0 mA, 0.5 mA and 2.5 mA -reduced if not uncomfortable). A set of 4*1 gel-filled cup-electrodes is placed over each of motor cortex. Each subject follows three sessions of 12 min length each day. During each session the tremor is measured while interleaving between low amplitude stimulation, high amplitude stimulation and No stimulation. By the end of each session we get 3 min of Low amplitude stimulation, 3 min of high amplitude stimulation and 6 min of No stimulation.
干预措施: tACS at tremor frequency (Device)
Arm stimulation
Each subject will be stimulated on only one day. Stimulation frequency is set similar to that of the tremor. Three stimulation amplitudes will be tested (0 mA, 0.5 mA and 2.5 mA -reduced if not uncomfortable). A set of 2*1 gel-filled cup-electrodes is placed over the contralateral arm. Each subject follows three sessions of 12 min length. During each session the tremor is measured while interleaving between low amplitude stimulation, high amplitude stimulation and No stimulation. By the end of each session we get 3 min of Low amplitude stimulation, 3 min of high amplitude stimulation and 6 min of No stimulation.
干预措施: tACS at tremor frequency (Device)
结局指标
主要结局
Change in tremor-stimulation phase entrainment- Session 1
时间窗: During session one of 12 minutes length (6 minutes with stimulation ON and 6 minutes with stimulation OFF)
phase locking value was calculated between the tremor signal measured using accelerometer and the stimulation signal
Change in tremor-stimulation phase entrainment- Session 3
时间窗: During session three of 12 minutes length (6 minutes with stimulation ON and 6 minutes with stimulation OFF)
phase locking value was calculated between the tremor signal measured using accelerometer and the stimulation signal
Change in tremor-stimulation phase entrainment- Session 2
时间窗: During session two of 12 minutes length (6 minutes with stimulation ON and 6 minutes with stimulation OFF)
phase locking value was calculated between the tremor signal measured using accelerometer and the stimulation signal
次要结局
- Sensation rating(Measured up to 5 minutes before the start of the stimulation sessions and lasts for 10 seconds of stimulation after which the subject gives the rating)
- Sensation threshold(Measured 3 minutes before the start of the stimulation sessions and lasts up to 2 minutes. Stimulation at each amplitude lasts for 10 seconds)
研究者
Myles Mc Laughlin
Principal Investigator
KU Leuven