Effects of Cerebellar Transcranial Direct Current Stimulation (ctDCS) on Motor Learning of Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Changes on implicit motor learning
研究概览
简要总结
A crossover trial with healthy volunteers will be conducted. Three sessions will be performed with at least 48 hours washout period to minimize carry-over effects. In each session, volunteers will be submitted to: fatigue and attention levels evaluation, handwriting test, serial reaction time task (SRTT) before and after ctDCS conditions and after session, a performance perception evaluation.
详细描述
A crossover, pseudo-randomized, sham-controlled and triple blind will be performed in order to evaluate ctDCS effects on motor learning, since evidence pointed to the crucial role of cerebellum on motor behavior. A non-involved research will conduct a pseudo-randomization (www.randomization.com) to warrant the counterbalanced sessions order and the allocation concealment. Volunteers, researchers and statistical analysis will be blinded to ctDCS condition.
After given prior informed consent, volunteers will be submitted to three experimental sessions: anodal ctDCS, cathodal ctDCS and sham ctDCS. Fatigue and attention levels, handwriting test and SRTT will be performed before and after stimulation. In addition, performance perception evaluation will be assessed at the end of session.
Electrical current will be delivered through a DC stimulator (NeuroConn Plus, Germany) using a pair of saline-soaked sponge electrodes (surface 35cm²). The active electrode (anode or cathode) will be placed over the left cerebellum (3 cm lateral to the inion) and the reference, over the left arm with current intensity of 2mA, fade in and fade out of 10 seconds, during 20 minutes. Sham tDCS has been used in several studies to evaluate active tDCS effects.
Sham ctDCS will be applied using the same electrodes placement and parameter settings of cathodal ctDCS however, stimulation will last only 30 seconds but volunteers will be with electrodes montage for 20 minutes. Because the device will be automatically turned off without volunteer's perception, early sensations (mild to moderate tingling) on stimulation site will be experienced without inducing any modulatory effects. Moreover, after each ctDCS session, an adverse effects questionnaire will be applied.
Fatigue and attention levels will be measured through an analogue scale graded from 0 to 10, where 0 means lower fatigue or attention levels and 10, the higher fatigue or attention levels.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Right-handed (assessed by Edinburgh Handedness Inventory)
- •Healthy volunteers (self report)
- •Absence of neurological and psychiatric diseases
- •No history of severe musculoskeletal injury on wrists and fingers
- •Without using drugs or neuroactive substances regularly
排除标准
- •Pregnancy
- •Presence of metallic implant in close contact to the target stimulation area
- •Acute eczema under the target stimulation area
- •Pacemaker
- •History of seizures or epilepsy
- •Hemodynamic instability
研究组 & 干预措施
anodal ctDCS
Volunteers will be submitted to anodal ctDCS + motor learning assessments (SRTT and Handwriting test).
干预措施: tDCS (Device)
cathodal ctDCS
Volunteers will be submitted to cathodal ctDCS + motor learning assessments (SRTT and Handwriting test).
干预措施: tDCS (Device)
sham ctDCS
Volunteers will be submitted to sham ctDCS + motor learning assessments (SRTT and Handwriting test)
干预措施: tDCS (Device)
结局指标
主要结局
Changes on implicit motor learning
时间窗: One week (before and after ctDCS)
Serial reaction time task evaluates implicit motor learning through software with visual stimuli presented on a computer screen in four different positions. Volunteer must press, with the non-dominant hand, a corresponding key with predetermined fingers as soon as possible when a highlighted star appears on the screen. The test comprises eight blocks with 120 trials each.
次要结局
- Changes on fatigue levels(One week (before and after ctDCS))
- Changes on explicit motor learning(One week (before and after ctDCS))
- Changes on attention levels(One week (before and after ctDCS))
研究者
Kátia Monte-Silva
PhD
Universidade Federal de Pernambuco