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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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 groups in NCT06414213
Study groupRoleWhat they receive
MI/Active tDCSExperimentalThe participants received active tDCS current and participated in the Motor Imagery intervention.
Receives: Behavioral: Motor Imagery (MI); Device: Active tDCS
MI/Sham tDCSSham comparatorThe participants received sham tDCS current and participated in the Motor Imagery intervention.
Receives: Behavioral: Motor Imagery (MI); Device: Sham tDCS
ControlNo interventionThe 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.

  1. 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

  2. Adherence to Interventions

    number of sessions attended

    Measured: Baseline to 1 week follow up

  3. Retention of Participants

    number of participants completing intervention and follow-up assessment

    Measured: Baseline to 1 week follow up

  4. Adverse Events in Each Study Arm

    Number of unexpected and/or serious adverse events

    Measured: Baseline to 1 week follow up

  5. Time to Completion

    Recorded time to complete the obstacle course

    Measured: Baseline to 1 week follow up

Secondary outcomes (1)

  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.

  1. First posted16 May 2024
  2. Study start20 Sep 2022
  3. Primary completion22 Dec 2022
  4. Study completion22 Dec 2022

Resources

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)
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
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 32808403

  • 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.

    PubMed 39799141

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.

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