跳至主要内容
临床试验/NCT04321304
NCT04321304已完成不适用

Impact of Transcranial Direct Current Stimulation Intensity on Leg Muscle Fatigability in Healthy Adults

University of Iowa2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
2
主要终点
Distance walked in the 6 Minute Walk Test

研究概览

简要总结

Transcranial direct current stimulation (tDCS) is a painless,non-invasive means of increasing brain excitability. It has been used for several years and in many populations to improve physical and psychological outcomes. Although many tDCS devices are capable of a range of stimulation intensities (e.g., 0 mA - 5 mA), the intensities currently employed in most tDCS research are ≤ 2 mA, which are sufficient to elicit measurable improvements; but, these improvements might be expanded at higher intensities. In the beginning, when the safety of tDCS was still being established for human subjects, careful and moderate approaches to stimulation protocols were warranted. However, recent work using stimulation at higher intensities, i.e. up to 4 mA, has been performed in many populations and was found to have no additional negative side-effects. Now that the safety of tDCS at higher intensities is better established, work exploring the differences in performance between moderate (i.e. 2 mA) and higher (i.e. 4 mA) intensities is necessary to determine if increasing intensity increases the effectiveness of the desired outcome.

Prospective participants will include 40 healthy young adults (all right-side dominant) that will be recruited to complete four randomly ordered stimulation sessions (Baseline, 2 mA, 4 mA, and sham), separated by at least 5 days. Each session will involve one visit to the Integrative Neurophysiology Laboratory (INPL) and will last for approximately one hour. We expect data collection to last 6 months. The first session includes leg strength measurements and fatigue tasks of both legs, as well as a baseline 6 min walk test (6MWT) to determine fatigued walking characteristics. The following three sessions will include performing a random tDCS condition (2 mA, 4 mA, or sham) over the brain area that controls the participant's dominant leg for 15 minutes prior to and then throughout the duration of the fatigue task of the dominant leg (16-20 min total stimulation time). The fatigue task for the nondominant leg will be performed after a 10 minute energy recovery period. After the fatigue task has been completed for both legs, the participants will perform the 6MWT.

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, Investigator)

盲法说明

Double-blind

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Young adult (18-30 yrs)
  • right-side dominant
  • able to independently walk for 6 min
  • at least 30 min of moderate-intensity, physical activity on at least 3 days of the week for at least the last 3 months
  • without chronic neurological, psychiatric, or medical conditions
  • not taking any psychoactive medications

排除标准

  • known holes or fissures in the skull
  • metallic objects or implanted devices in the skull (e.g., metal plate)
  • current student of study personnel
  • under the direct supervision of study personnel

结局指标

主要结局

Distance walked in the 6 Minute Walk Test

时间窗: Through study completion, up to 6 months

Walk back and forth between two markers spaced 30 meters apart for six minutes

Fatigue index from the isokinetic fatigue test

时间窗: Through study completion, up to 6 months

Perform 40 consecutive flexion and extension repetitions of the knee on the dominant leg. After a 10 minute rest, do the same task on the the non-dominant leg.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Craig D. Workman, PhD

Postdoctoral Scholar

University of Iowa

研究点 (2)

Loading locations...

相似试验