Enhancing Locomotor Learning With Motor Imagery and Transcranial Direct Current Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Prefrontal Cortical Activity
研究概览
简要总结
The primary goal of this research was to assess the practicality and initial effectiveness of a motor imagery (MI) intervention combined with elements of action observation (AO), alongside active or sham transcranial direct current stimulation (tDCS) over the prefrontal cortex (PFC), on locomotor learning in healthy adults. Feasibility was determined by examining recruitment rates, participant engagement, and safety measures. The efficacy of the intervention was gauged by analyzing the time taken to complete tasks and changes in cerebral blood flow immediately after the intervention and one week later. The study was guided by three main hypotheses: (1) the intervention techniques would be well-received and safe for the participants; (2) compared to a control group, MI training would lead to better learning outcomes and retention of learning; (3) in comparison to the control and sham tDCS groups, active tDCS would result in superior learning outcomes and retention of learning.
详细描述
The study implemented a double-blind, randomized, controlled trial design. Participants were tested three times over 7 days. After study enrollment, the participants were randomly assigned to one of three groups: MIActive (receiving active tDCS stimulation and participating in MI protocol), MISham (receiving sham tDCS stimulation and participating in MI protocol), and Control (receiving no stimulation and participating in an unrelated video-watching task) by a research member not associated with data collection. Allocation ratio was 1:1:1 and a block randomization approach was employed to maintain an equal distribution of participants across the three groups throughout the study. Study participants and assessors were blinded to assignment of active or sham tDCS. The independent variables were time (pre, post, and retention trials) and group (MIActive, MISham and Control), and the dependent variables were time to completion of a complex obstacle course and the amount of change in oxygenated hemoglobin (ΔO2Hb) during performance of that task.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female adults age 18 and older
- •Freely ambulatory (no assistive walking aids)
排除标准
- •Failure to meet specific inclusion criteria
- •History or presence of any neurological disease
- •Low visual ability, operationally defined as visual acuity less than 20/70 on the standard eye chart
- •Extreme difficulty performing walking tasks due to low visual ability
- •Clinical judgment of the investigative team
- •Additionally, subjects who are determined to be at increased risk for adverse events during the tDCS procedure, as determined by the tDCS screening questionnaire
结局指标
主要结局
Prefrontal Cortical Activity
时间窗: Baseline to 1 week follow up
Functional near infrared spectroscopy (fNIRS) monitor (OctaMon by Artinis Medical Systems), changes in oxygenated hemoglobin concentration (O2Hb) relative to a baseline task
Adherence to Interventions
时间窗: Baseline to 1 week follow up
number of sessions attended
Retention of Participants
时间窗: Baseline to 1 week follow up
number of participants completing intervention and follow-up assessment
Adverse Events in Each Study Arm
时间窗: Baseline to 1 week follow up
Number of unexpected and/or serious adverse events
Time to Completion
时间窗: Baseline to 1 week follow up
Recorded time to complete the obstacle course
次要结局
- Kinesthetic and Visual Imagery Questionnaire (KVIQ)(Baseline to 1 week follow up)
研究者
Jared W Skinner
Assistant Professor
Appalachian State University