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CompletedNCT06414213ELLMITSUpdated Feb 3, 2025Results posted

Improving Locomotor Learning With Brain Stimulation

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

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Sep 2022, registered May 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Motor Learning

Keywords

  • randomized
  • double-blinded
  • tDCS
  • motor imagery
  • functional near-infrared spectroscopy (fNIRS)
  • controlled trial
03

In context

Lead sponsor

Appalachian State University is the lead sponsor of 41 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male and female adults age 18 and older
  • Freely ambulatory (no assistive walking aids)

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    MI/Active tDCS

    The participants received active tDCS current and participated in the Motor Imagery intervention.

    Behavioral: Motor Imagery (MI) · Device: Active tDCS

  • Sham comparator
    MI/Sham tDCS

    The participants received sham tDCS current and participated in the Motor Imagery intervention.

    Behavioral: Motor Imagery (MI) · Device: Sham tDCS

  • No intervention
    Control

    The control group watched an unrelated (non stimulating) video for a duration equal to the MI groups' intervention tasks.

Interventions

  • BehavioralMotor 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.

  • DeviceActive tDCS

    The participants received a 20-minute "active" session of tDCS at a 2-milliamp current.

  • DeviceSham tDCS

    The participants received a 20-minute session of "sham" tDCS.

06

What researchers measure

Primary outcomes

  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

    Time frame: Baseline to 1 week follow up

  2. Adherence to Interventions

    number of sessions attended

    Time frame: Baseline to 1 week follow up

  3. Retention of Participants

    number of participants completing intervention and follow-up assessment

    Time frame: Baseline to 1 week follow up

  4. Adverse Events in Each Study Arm

    Number of unexpected and/or serious adverse events

    Time frame: Baseline to 1 week follow up

  5. Time to Completion

    Recorded time to complete the obstacle course

    Time frame: 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.

    Time frame: Baseline to 1 week follow up

07

Results

Posted Feb 3, 2025

Participant flow

Participant flow — Overall Study
MilestoneMI/Active tDCSMI/Sham tDCSControl
Started131213
Completed121110
Not completed113
Withdrew: Lost to follow-up113

Outcome measures

PrimaryPrefrontal 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
Reported as:
Mean · μM
Prefrontal Cortical Activity
μMMI/Active tDCSMI/Sham tDCSControl
Baseline (Pre-Intervention)0.04 ± 0.470.11 ± 0.680.58 ± 0.50
20 minutes post Baseline (Post-Intervention)-0.62 ± 0.70-0.19 ± 0.910.20 ± 0.81
1 Week Follow up-0.61 ± 0.510.24 ± 1.110.12 ± 0.64
PrimaryAdherence to Interventions

number of sessions attended

Time frame:
Baseline to 1 week follow up
Reported as:
Mean · Numbers of session completed
Adherence to Interventions
Numbers of session completedMI/Active tDCSMI/Sham tDCSControl
Adherence to Interventions1.92 ± 0.271.91 ± 0.281.77 ± .43
PrimaryRetention of Participants

number of participants completing intervention and follow-up assessment

Time frame:
Baseline to 1 week follow up
Reported as:
Count of participants · Participants
Retention of Participants
ParticipantsMI/Active tDCSMI/Sham tDCSControl
Retention of Participants121110
PrimaryAdverse Events in Each Study Arm

Number of unexpected and/or serious adverse events

Time frame:
Baseline to 1 week follow up
Reported as:
Number · number of adverse events
Adverse Events in Each Study Arm
number of adverse eventsMI/Active tDCSMI/Sham tDCSControl
Adverse Events in Each Study Arm000
PrimaryTime to Completion

Recorded time to complete the obstacle course

Time frame:
Baseline to 1 week follow up
Reported as:
Mean · seconds
Time to Completion
secondsMI/Active tDCSMI/Sham tDCSControl
Baseline/Pre46.60 ± 7.847.64 ± 6.4239.27 ± 8.1
Post-Test40.72 ± 3.4547.21 ± 4.337.2 ± 7.8
1 Week Follow up39.1 ± 3.9845.43 ± 3.836.1 ± 8.3
SecondaryKinesthetic 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
Reported as:
Mean · score on a scale
Kinesthetic and Visual Imagery Questionnaire (KVIQ)
score on a scaleMI/Active tDCSMI/Sham tDCS
External Imagery21.3 ± 4.122.7 ± 3.0
Kinesthetic Imagery22.9 ± 4.721.7 ± 4.5

Adverse events

Collected over from baseline to follow-up. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
MI/Active tDCS0/13 (0%)0/13 (0%)0/13 (0%)
MI/Sham tDCS0/12 (0%)0/12 (0%)0/12 (0%)
Control0/13 (0%)0/13 (0%)0/13 (0%)

Baseline characteristics

participants were excluded if they did not attend the follow up session

Age, Categorical
Age, Categorical(Participants)MI/Active tDCSMI/Sham tDCSControlTotal
<=18 years0000
Between 18 and 65 years13121338
>=65 years0000
Age, Continuous
Age, Continuous(years)MI/Active tDCSMI/Sham tDCSControlTotal
Mean22.42 ± 1.9822.36 ± 2.0624.1 ± 4.0422.96 ± 2.69
Sex: Female, Male
Sex: Female, Male(Participants)MI/Active tDCSMI/Sham tDCSControlTotal
Female11111032
Male2136
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)MI/Active tDCSMI/Sham tDCSControlTotal
Count of participants———0
08

Study locations

1 site
  • Appalachian State University
    Boone, North Carolina 28607, United States
09

References and documents

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 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — There is not a plan to make Individual Participant Data (IPD) available.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06414213
Lead sponsor
Appalachian State University
Responsible party
Jared W Skinner (Assistant Professor, Appalachian State University) — Principal investigator
First posted
May 16, 2024
Start date
Sep 20, 2022
Primary completion
Dec 22, 2022
Completion
Dec 22, 2022
Results posted
Feb 3, 2025
Last update
Feb 3, 2025

Study contacts

Jared W Skinner, PhD
principal investigator · Appalachian State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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