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Completed

NCT Number: NCT06414213

Improving Locomotor Learning With Brain 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.

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Key information

Conditions

Motor Learning

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Appalachian State University

Boone, North Carolina, 28607, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  2. Adherence to Interventions

    Time frame: Baseline to 1 week follow up

    number of sessions attended

  3. Retention of Participants

    Time frame: Baseline to 1 week follow up

    number of participants completing intervention and follow-up assessment

  4. Adverse Events in Each Study Arm

    Time frame: Baseline to 1 week follow up

    Number of unexpected and/or serious adverse events

  5. Time to Completion

    Time frame: Baseline to 1 week follow up

    Recorded time to complete the obstacle course

Secondary outcomes

  1. Kinesthetic and Visual Imagery Questionnaire (KVIQ)

    Time frame: Baseline to 1 week follow up

    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.

Sponsors and collaborators

Lead sponsor

Appalachian State University

Other

Registry information

Official study title

Enhancing Locomotor Learning With Motor Imagery and Transcranial Direct Current Stimulation

Acronym: ELLMITS

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 16, 2024
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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