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临床试验/NCT06039605
NCT06039605已完成不适用

Effects of Modulating Expectations About Noninvasive Brain Stimulation on Motor Learning

Arizona State University2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2023年10月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
2
主要终点
Performance on Motor Task One Week After Final Training Session

研究概览

简要总结

The purpose of this study is to test if priming expectations of transcranial Direct Current Stimulation (tDCS) can improve the efficacy of tDCS in enhancing motor learning.

详细描述

Transcranial direct current stimulation (tDCS) is currently being investigated by the scientific community as an intervention to improve motor learning in the context of neurorehabilitation (e.g., recover lost motor function after stroke) and performance enhancement (e.g., improve sports or technical skill training). More importantly, consumers believe that tDCS works. The expectation surrounding the benefits of tDCS for skill enhancement is so pervasive that the technology is sold for less than $200 and highly rated by the general public on Amazon.com. At the same time, there is considerable skepticism within the motor control field regarding the efficacy and mechanism of action of tDCS on motor learning, driven by highly irreproducible and equivocal findings between and even within laboratories.

How effective is tDCS, and could the positive effects of tDCS be attributable in part to a strong placebo effect? Placebo effects (i.e., a positive expectation associated with positive treatment outcomes), are well documented in other interventions like surgeries and pharmaceuticals, but have not been investigated in detail for tDCS, particularly in the motor domain. The lack of knowledge or consideration of the placebo effect may therefore explain why tDCS findings are so inconsistent within motor learning. Thus, the overall aim of this project is to determine whether people's expectations about tDCS change as a function of information about tDCS itself, and whether these changed expectations modulate the effects of tDCS on motor learning.

Transcranial direct current stimulation (tDCS) is a noninvasive, safe cortical stimulation technique that has been effectively used for enhancing and inhibiting sensory and motor performance when applied to the responsible cortical areas in healthy adults. For instance, anodal tDCS of primary motor area can improve motor execution. Recent research has investigated whether it is the expectation of receiving tDCS that has a greater impact on behavioral outcomes compared to the actual application of tDCS. This is important as many domains of science are challenged to reproduce previous research demonstrating a positive effect of tDCS on behavior. Thus, to decipher legitimate effects of tDCS on behavior it is important to quantify and compare how changes in behavior are related to tDCS, a key metric related to strength of the placebo effect, and how malleable these placebo effects are.

Individuals may participate in this study for up to four sessions (up to 3 training sessions and up to 1 follow-up visit, as assigned) in the span of approximately one week. The investigators expect that individuals will spend up to one hour during the training sessions, and (if applicable) around 15 minutes to complete the follow-up visit, if assigned. The follow-up visit would occur one week after the final training session.

This is a double-blind study in which participants will be randomly assigned to specific intervention methods.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

盲法说明

Participants and Research Assistants will be blinded to the groups/treatment conditions unless the participant is a "control". The investigator and/or research administration team will screen, enroll and assign participants to groups.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Must be 18 or older. Right-hand dominant
  • •Right-hand dominant

排除标准

  • •Mixed-handed or ambidextrous
  • •Left-hand dominant
  • •Seizure(s)
  • •Head injury resulting in a loss of consciousness that has required further investigation (including neurosurgery)
  • •Migraines
  • •Current medical diagnosis of a phycological or neurological condition
  • •Any metal in head (outside of mouth) such as shrapnel or surgical clips
  • •Any implanted devices (e.g. cardiac pacemaker, brain stimulator)
  • •Skin condition on scalp (e.g. psoriasis)
  • •Head wound that has not completely healed
  • •Adverse reactions to tDCS or any other brain stimulation technique (e.g. TMS, tRNS)
  • •Currently taking prescription medications or are self-medicating (including recreational drug use), other than the contraceptive pill?

研究组 & 干预措施

Control

No Intervention

This group will only receive motor training, which consists of 10 trials of motor training per day across 3 days, followed by a one-week follow-up of 2 trials.

tDCS1

Experimental

This group will receive motor training concurrent with 20 minutes of either sham or active tDCS. Sham tDCS will be a 30-second ramp up from 0 to 2 milliamps (MA), then a 30-second ramp-down from 2 mA to 0 mA. The next 18 minutes will have no stimulation (0 mA), starting at minute 19 with 30-second ramp up from 0 to 2 milliamps (MA), then a 30-second ramp-down from 2 mA to 0 mA. Active tDCS will ramp up to 2 mA in the first 30 seconds, then stay at 2 mA for 19 minutes, then ramp down to 0 mA.

干预措施: Transcranial Direct Current Stimulation (Device)

tDCS2

Experimental

This group will first read some information about tDCS based on cited studies. They will then receive the same motor training and tDCS as the tDCS1 arm.

干预措施: Transcranial Direct Current Stimulation (Device)

tDCS3

Experimental

This group will first read some information about tDCS based on cited studies, but different cited studies than the tDCS2 arm. They will then receive the same motor training and tDCS as the tDCS1 and 2 arms.

干预措施: Transcranial Direct Current Stimulation (Device)

结局指标

主要结局

Performance on Motor Task One Week After Final Training Session

时间窗: One-Week Follow-Up visit (Day 10)

This will be calculated as the average of two trials of the motor task that are completed one week after the last training session. The motor task is a timed test that requires participants to spoon two beans (kidney, raw) at a time from a center proximal "start" cup to three distal "target" cups as fast as possible. In short, this task requires multijoint coordination and limb reversal, and performance for each trial is measured in seconds.

次要结局

  • Change in Motor Performance Over the Course of Training(Day 1, 2, and 3)
  • Change in tDCS Expectations From Day 1 to Day 10(Day 1 and Follow-Up (Day 10))
  • Average Dwell Time(One-Week Follow-Up (Day 10))
  • Average Peak Reach Velocity(One-Week Follow-Up (Day 10))
  • Variability in Transcranial Direct Current Stimulation Expectations(Days 1, 2, 3, and 10)
  • Post-tDCS Symptom Questionnaire Score(Days 1, 2, and 3)
  • tDCS Expectation Scores(Days 1, 2, 3, and 10)

研究者

发起方
Arizona State University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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