Arizona State University
Tempe, Arizona, 85281, United States
NCT Number: NCT06039605
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Tempe, Arizona, 85281, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Transcranial Direct Current Stimulation (tDCS) is a minimal risk, non-invasive, neuromodulatory technique that involves the emission of a weak electrical current, traditionally via the placement of two electrodes attached to the scalp of a participant. tDCS is widely used for research purposes, the US FDA considers trials of tDCS as non-significant-risk. There are several review articles supporting the safety of tDCS usage in controlled human trials. According to a published meta-analysis , the use of conventional tDCS protocols in human trials (≤40 min, ≤4 mA) has not produced any reports of a Serious Adverse Effect or irreversible injury across over 33,200 sessions.
Other names: tDCS
Time frame: Change from Baseline to One-Week Follow Up visit (10 days)
This will be calculated as the average of two trials of the motor task that are completed one week after the last training session, after controlling for baseline. 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.
Time frame: Three days
This outcome measure will be measured as the slope of the line fitted to the motor task performance across all 30 training trials, when trial is transformed to a logarithmic scale. This transformation is done to account for the fact that change in performance is non-linear. 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.
Time frame: 7 days
This will be the change (Day 1 minus Day 7) in expectations of tDCS. The tDCS expectation scores are taken from a 1-item survey adapted from the Expectation Assessment Scale, where scores range from 0 (no expectation) to 8 (high expectations); a score of 4 is considered neutral.
Time frame: 10 days
This is the average amount of time spent in the home cup for each repetition, averaged across the two follow-up trials, controlling for baseline.
Time frame: 10 days
his is the average peak velocity for the outward portion of each repetition, averaged across the two follow-up trials, controlling for baseline.
Time frame: 10 days
This is the coefficient of variation for tDCS expectation scores across the 4 study days (Days 1, 2, 3, and 10). The tDCS expectation scores are taken from a 1-item survey adapted from the Expectation Assessment Scale, where scores range from 0 (no expectation) to 8 (high expectations); a score of 4 is considered neutral.
Time frame: 10 days
This is calculated as the total number of points self-rated by the participant on a 14-item questionnaire with answers for each item ranging from 1 ("absent") to 10 ("severe").
Arizona State University
Other
Effects of Modulating Expectations About Noninvasive Brain Stimulation on Motor Learning
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05019612
Endometriosis, Expectations
Hamburg, Germany
View Trial DetailsNCT05733039
Agnosia, Expectations
Bern, Canton of Bern, Switzerland
View Trial DetailsNCT05191277
Antidepressants, Behavior
Hamburg, Free and Hanseatic City of Hamburg, Germany
View Trial DetailsNCT06493630
Behavior, Breast Feeding
Amasya, Turkey (Türkiye)
View Trial Details