An interventional study of Motor Imagery (MI) and Active tDCS in Motor Learning, sponsored by Appalachian State University. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by Appalachian State University · Not applicable, Interventional, and Supportive care
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.
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.
Appalachian State University is the lead sponsor of 41 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
The participants received active tDCS current and participated in the Motor Imagery intervention.
Behavioral: Motor Imagery (MI) · Device: Active tDCS
The participants received sham tDCS current and participated in the Motor Imagery intervention.
Behavioral: Motor Imagery (MI) · Device: Sham tDCS
The control group watched an unrelated (non stimulating) video for a duration equal to the MI groups' intervention tasks.
Participants watched a standardized video sequence that consisted of an individual completing twenty walking trials (twenty video clips-each clip represents one trial). Participants were instructed to place their focus intently on the person performing the obstacle course and try to imagine themselves doing the skill. Periodically, a reminder would appear to help focus and redirect participant's attention to different aspects of the video or different versions of imagery (visual or kinesthetic). Participants will watch the video first at normal play speed and then in slow motion after a short break (30 secs to 1 min). Total training time will be approximately 20 mins which is consistent with the duration of the locomotor intervention and duration of stimulation.
The participants received a 20-minute "active" session of tDCS at a 2-milliamp current.
The participants received a 20-minute session of "sham" tDCS.
Prefrontal Cortical Activity
Functional near infrared spectroscopy (fNIRS) monitor (OctaMon by Artinis Medical Systems), changes in oxygenated hemoglobin concentration (O2Hb) relative to a baseline task
Time frame: Baseline to 1 week follow up
Adherence to Interventions
number of sessions attended
Time frame: Baseline to 1 week follow up
Retention of Participants
number of participants completing intervention and follow-up assessment
Time frame: Baseline to 1 week follow up
Adverse Events in Each Study Arm
Number of unexpected and/or serious adverse events
Time frame: Baseline to 1 week follow up
Time to Completion
Recorded time to complete the obstacle course
Time frame: Baseline to 1 week follow up
Kinesthetic and Visual Imagery Questionnaire (KVIQ)
The Kinesthetic and Visual Imagery Questionnaire (KVIQ-10) measures the ability to imagine movements. This test evaluates the subject's ability to see (visual imagery) and feel (kinesthetic imagery) movements. The KVIQ-10 total score ranges from 10 to 50 (visual and kinesthetic subscale scores each range from 5 to 25).The KVIQ consists of 10 items, (5 movements for each scale), each item being a separate movement followed by rating the ease or difficulty of generating those self-images on a 5-point Likert scale (where 1 = no image or sensation and 5 = Image as clear as seeing or as intense as executing the action). Higher scores reflect higher imagery abilities.
Time frame: Baseline to 1 week follow up
| Milestone | MI/Active tDCS | MI/Sham tDCS | Control |
|---|---|---|---|
| Started | 13 | 12 | 13 |
| Completed | 12 | 11 | 10 |
| Not completed | 1 | 1 | 3 |
| Withdrew: Lost to follow-up | 1 | 1 | 3 |
Functional near infrared spectroscopy (fNIRS) monitor (OctaMon by Artinis Medical Systems), changes in oxygenated hemoglobin concentration (O2Hb) relative to a baseline task
| μM | MI/Active tDCS | MI/Sham tDCS | Control |
|---|---|---|---|
| Baseline (Pre-Intervention) | 0.04 ± 0.47 | 0.11 ± 0.68 | 0.58 ± 0.50 |
| 20 minutes post Baseline (Post-Intervention) | -0.62 ± 0.70 | -0.19 ± 0.91 | 0.20 ± 0.81 |
| 1 Week Follow up | -0.61 ± 0.51 | 0.24 ± 1.11 | 0.12 ± 0.64 |
number of sessions attended
| Numbers of session completed | MI/Active tDCS | MI/Sham tDCS | Control |
|---|---|---|---|
| Adherence to Interventions | 1.92 ± 0.27 | 1.91 ± 0.28 | 1.77 ± .43 |
number of participants completing intervention and follow-up assessment
| Participants | MI/Active tDCS | MI/Sham tDCS | Control |
|---|---|---|---|
| Retention of Participants | 12 | 11 | 10 |
Number of unexpected and/or serious adverse events
| number of adverse events | MI/Active tDCS | MI/Sham tDCS | Control |
|---|---|---|---|
| Adverse Events in Each Study Arm | 0 | 0 | 0 |
Recorded time to complete the obstacle course
| seconds | MI/Active tDCS | MI/Sham tDCS | Control |
|---|---|---|---|
| Baseline/Pre | 46.60 ± 7.8 | 47.64 ± 6.42 | 39.27 ± 8.1 |
| Post-Test | 40.72 ± 3.45 | 47.21 ± 4.3 | 37.2 ± 7.8 |
| 1 Week Follow up | 39.1 ± 3.98 | 45.43 ± 3.8 | 36.1 ± 8.3 |
The Kinesthetic and Visual Imagery Questionnaire (KVIQ-10) measures the ability to imagine movements. This test evaluates the subject's ability to see (visual imagery) and feel (kinesthetic imagery) movements. The KVIQ-10 total score ranges from 10 to 50 (visual and kinesthetic subscale scores each range from 5 to 25).The KVIQ consists of 10 items, (5 movements for each scale), each item being a separate movement followed by rating the ease or difficulty of generating those self-images on a 5-point Likert scale (where 1 = no image or sensation and 5 = Image as clear as seeing or as intense as executing the action). Higher scores reflect higher imagery abilities.
| score on a scale | MI/Active tDCS | MI/Sham tDCS |
|---|---|---|
| External Imagery | 21.3 ± 4.1 | 22.7 ± 3.0 |
| Kinesthetic Imagery | 22.9 ± 4.7 | 21.7 ± 4.5 |
Collected over from baseline to follow-up. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MI/Active tDCS | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| MI/Sham tDCS | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Control | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
participants were excluded if they did not attend the follow up session
| Age, Categorical(Participants) | MI/Active tDCS | MI/Sham tDCS | Control | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 12 | 13 | 38 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | MI/Active tDCS | MI/Sham tDCS | Control | Total |
|---|---|---|---|---|
| Mean | 22.42 ± 1.98 | 22.36 ± 2.06 | 24.1 ± 4.04 | 22.96 ± 2.69 |
| Sex: Female, Male(Participants) | MI/Active tDCS | MI/Sham tDCS | Control | Total |
|---|---|---|---|---|
| Female | 11 | 11 | 10 | 32 |
| Male | 2 | 1 | 3 | 6 |
| Race and Ethnicity Not Collected(Participants) | MI/Active tDCS | MI/Sham tDCS | Control | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — There is not a plan to make Individual Participant Data (IPD) available.
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Appalachian State University