Motor LearningELLMITSNCT06414213
Improving Locomotor Learning With Brain Stimulation
A study testing Motor Imagery (MI) and Active tDCS in people with Motor Learning, run by Appalachian State University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Learning
- What is being tested?
- Motor Imagery (MI) and Active tDCS
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2022to 22 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female adults age 18 and older
- Freely ambulatory (no assistive walking aids)
Who cannot join
- Failure to meet specific inclusion criteria
- History or presence of any neurological disease
- Low visual ability, operationally defined as visual acuity less than 20/70 on the standard eye chart
- Extreme difficulty performing walking tasks due to low visual ability
- Clinical judgment of the investigative team
- Additionally, subjects who are determined to be at increased risk for adverse events during the tDCS procedure, as determined by the tDCS screening questionnaire
Trial locations and contacts
1 site in 1 country.
United States1 site
Appalachian State University
Boone, North Carolina, 28607
About this study
Official title: Enhancing Locomotor Learning With Motor Imagery and Transcranial Direct Current Stimulation
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.
Read the detailed description
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.
- Conditions
- Motor Learning
- Being tested
- Motor Imagery (MI), Active tDCS, Sham tDCS
- Keywords
- randomized, double-blinded, tDCS, motor imagery, functional near-infrared spectroscopy (fNIRS), controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Imagery (MI)Behavioural
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 tDCSDevice
The participants received a 20-minute "active" session of tDCS at a 2-milliamp current.
Sham tDCSDevice
The participants received a 20-minute session of "sham" tDCS.
| Study group | Role | What they receive |
|---|---|---|
| MI/Active tDCS | Experimental | The participants received active tDCS current and participated in the Motor Imagery intervention. Receives: Behavioral: Motor Imagery (MI); Device: Active tDCS |
| MI/Sham tDCS | Sham comparator | The participants received sham tDCS current and participated in the Motor Imagery intervention. Receives: Behavioral: Motor Imagery (MI); Device: Sham tDCS |
| Control | No intervention | The control group watched an unrelated (non stimulating) video for a duration equal to the MI groups' intervention tasks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 1 week follow up
Adherence to Interventions
number of sessions attended
Measured: Baseline to 1 week follow up
Retention of Participants
number of participants completing intervention and follow-up assessment
Measured: Baseline to 1 week follow up
Adverse Events in Each Study Arm
Number of unexpected and/or serious adverse events
Measured: Baseline to 1 week follow up
Time to Completion
Recorded time to complete the obstacle course
Measured: Baseline to 1 week follow up
Secondary outcomes (1)
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.
Measured: Baseline to 1 week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start20 Sep 2022
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Motor LearningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Appalachian State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jared W Skinner, Appalachian State University
- Investigators
- Jared W Skinner, PhD, Principal investigator, Appalachian State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414213
- Sponsor's protocol ID
- IRB-21-0198
- Acronym
- ELLMITS
- Status last verified
- Jan 2025
- First submitted
- 3 May 2024
- Last updated
- 3 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is not a plan to make Individual Participant Data (IPD) available.
Publications
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.
PubMed 32808403Gamwell-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.
PubMed 39799141
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Locomotor Learning With Motor Imagery and Transcranial Direct Current Stimulation
- ClinicalTrials.gov ID
- NCT06414213
- Acronym / sponsor ID
- ELLMITS / IRB-21-0198
- Conditions
- Motor Learning
- Keywords
- randomized, double-blinded, tDCS, motor imagery, functional near-infrared spectroscopy (fNIRS), controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Appalachian State UniversityUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 16 May 2024 (actual)
- Results
- Posted 3 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MI/Active tDCS | Experimental | Behavioral: Motor Imagery (MI), Device: Active tDCSThe participants received active tDCS current and participated in the Motor Imagery intervention. |
| MI/Sham tDCS | Sham comparator | Behavioral: Motor Imagery (MI), Device: Sham tDCSThe 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female adults age 18 and older
- Freely ambulatory (no assistive walking aids)
Key exclusion criteria (6 listed)
- Failure to meet specific inclusion criteria
- History or presence of any neurological disease
- Low visual ability, operationally defined as visual acuity less than 20/70 on the standard eye chart
- Extreme difficulty performing walking tasks due to low visual ability
- Clinical judgment of the investigative team
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | MI/Active tDCS, MI/Sham tDCS |
| Active tDCSThe participants received a 20-minute "active" session of tDCS at a 2-milliamp current. | Device | MI/Active tDCS |
| Sham tDCSThe participants received a 20-minute session of "sham" tDCS. | Device | MI/Sham tDCS |
Primary outcome
Prefrontal Cortical Activity
Time frame: Baseline to 1 week follow up
Functional near infrared spectroscopy (fNIRS) monitor (OctaMon by Artinis Medical Systems), changes in oxygenated hemoglobin concentration (O2Hb) relative to a baseline task
Adherence to Interventions
Time frame: Baseline to 1 week follow up
number of sessions attended
Retention of Participants
Time frame: Baseline to 1 week follow up
number of participants completing intervention and follow-up assessment
Adverse Events in Each Study Arm
Time frame: Baseline to 1 week follow up
Number of unexpected and/or serious adverse events
Time to Completion
Time frame: Baseline to 1 week follow up
Recorded time to complete the obstacle course
1 secondary outcome
Kinesthetic and Visual Imagery Questionnaire (KVIQ)
Time frame: Baseline to 1 week follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32808403Clark 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.
- Derived from this study: PubMed 39799141Gamwell-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.
- Individual participant dataSharing planned: No. There is not a plan to make Individual Participant Data (IPD) available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jared W Skinner, PhD principal investigator
Appalachian State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor Imagery (MI) and Active tDCS in people with Motor Learning, run by Appalachian State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prefrontal Cortical Activity (time frame: Baseline to 1 week follow up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06414213, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.