Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MI/Active tDCS | Experimental | The participants received active tDCS current and participated in the Motor Imagery intervention. |
|
| MI/Sham tDCS | Sham Comparator | The participants received sham tDCS current and participated in the Motor Imagery intervention. |
|
| Control | No Intervention | The control group watched an unrelated (non stimulating) video for a duration equal to the MI groups' intervention tasks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motor Imagery (MI) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to 1 week follow up |
| Adherence to Interventions | number of sessions attended | Baseline to 1 week follow up |
| Retention of Participants | number of participants completing intervention and follow-up assessment | Baseline to 1 week follow up |
| Adverse Events in Each Study Arm | Number of unexpected and/or serious adverse events | Baseline to 1 week follow up |
| Time to Completion | Recorded time to complete the obstacle course | Baseline to 1 week follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jared W Skinner, PhD | Appalachian State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Appalachian State University | Boone | North Carolina | 28607 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32808403 | Background | Clark DJ, Chatterjee SA, Skinner JW, Lysne PE, Sumonthee C, Wu SS, Cohen RA, Rose DK, Woods AJ. Combining Frontal Transcranial Direct Current Stimulation With Walking Rehabilitation to Enhance Mobility and Executive Function: A Pilot Clinical Trial. Neuromodulation. 2021 Jul;24(5):950-959. doi: 10.1111/ner.13250. Epub 2020 Aug 18. | |
| 39799141 |
Not provided
Not provided
There is not a plan to make Individual Participant Data (IPD) available.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | MI/Active tDCS | The participants received active tDCS current and participated in the Motor Imagery intervention. Motor Imagery (MI): 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. Active tDCS: The participants received a 20-minute "active" session of tDCS at a 2-milliamp current. |
| FG001 | MI/Sham tDCS | The participants received sham tDCS current and participated in the Motor Imagery intervention. Motor Imagery (MI): 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. Sham tDCS: The participants received a 20-minute session of "sham" tDCS. |
| FG002 | Control | The control group watched an unrelated (non stimulating) video for a duration equal to the MI groups' intervention tasks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
participants were excluded if they did not attend the follow up session
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MI/Active tDCS | The participants received active tDCS current and participated in the Motor Imagery intervention. Motor Imagery (MI): 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. Active tDCS: The participants received a 20-minute "active" session of tDCS at a 2-milliamp current. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | μM | Baseline to 1 week follow up |
|
from baseline to follow-up
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MI/Active tDCS | The participants received active tDCS current and participated in the Motor Imagery intervention. Motor Imagery (MI): 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. Active tDCS: The participants received a 20-minute "active" session of tDCS at a 2-milliamp current. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jared Skinner | Appalachian State University | 828-262-2512 | skinnerjw@appstate.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2022 | May 22, 2024 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Active tDCS | Device | The participants received a 20-minute "active" session of tDCS at a 2-milliamp current. |
|
| Sham tDCS | Device | The participants received a 20-minute session of "sham" tDCS. |
|
| Baseline to 1 week follow up |
| Gamwell-Muscarello HE, Needle AR, Meucci M, Skinner JW. Improving locomotor performance with motor imagery and tDCS in young adults. Sci Rep. 2025 Jan 11;15(1):1748. doi: 10.1038/s41598-025-86039-2. |
| BG001 | MI/Sham tDCS | The participants received sham tDCS current and participated in the Motor Imagery intervention. Motor Imagery (MI): 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. Sham tDCS: The participants received a 20-minute session of "sham" tDCS. |
| BG002 | Control | The control group watched an unrelated (non stimulating) video for a duration equal to the MI groups' intervention tasks. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | MI/Sham tDCS | The participants received sham tDCS current and participated in the Motor Imagery intervention. Motor Imagery (MI): 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. Sham tDCS: The participants received a 20-minute session of "sham" tDCS. |
| OG002 | Control | The control group watched an unrelated (non stimulating) video for a duration equal to the MI groups' intervention tasks. |
|
|
| Primary | Adherence to Interventions | number of sessions attended | Posted | Mean | Standard Deviation | Numbers of session completed | Baseline to 1 week follow up |
|
|
|
| Primary | Retention of Participants | number of participants completing intervention and follow-up assessment | Posted | Count of Participants | Participants | Baseline to 1 week follow up |
|
|
|
| Primary | Adverse Events in Each Study Arm | Number of unexpected and/or serious adverse events | Posted | Number | number of adverse events | Baseline to 1 week follow up |
|
|
|
| Primary | Time to Completion | Recorded time to complete the obstacle course | Posted | Mean | Standard Deviation | seconds | Baseline to 1 week follow up |
|
|
|
| Secondary | 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. | The motor imagery/active tDCS and motor imagery/sham tDCS groups participated in the KVIQ-10 assessments, receiving motor imagery and active or sham transcranial direct current stimulation, respectively. These assessments evaluated their kinesthetic and visual imagery abilities, in order to compare their relative capabilities. The control group did not participate in the KVIQ-10 because they did not engage in motor imagery training, making the administration of the KVIQ-10 irrelevant for them. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 1 week follow up |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | MI/Sham tDCS | The participants received sham tDCS current and participated in the Motor Imagery intervention. Motor Imagery (MI): 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. Sham tDCS: The participants received a 20-minute session of "sham" tDCS. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | Control | The control group watched an unrelated (non stimulating) video for a duration equal to the MI groups' intervention tasks. | 0 | 13 | 0 | 13 | 0 | 13 |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
|
| 1 Week Follow up |
|