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Improving Locomotor Learning With Brain Stimulation

Not Applicable
Completed
Conditions
Motor Learning
Interventions
Behavioral: Motor Imagery (MI)
Device: Active tDCS
Device: Sham tDCS
Registration Number
NCT06414213
Lead Sponsor
Appalachian State University
Brief 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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
38
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
MI/Active tDCSMotor Imagery (MI)The participants received active tDCS current and participated in the Motor Imagery intervention.
MI/Active tDCSActive tDCSThe participants received active tDCS current and participated in the Motor Imagery intervention.
MI/Sham tDCSMotor Imagery (MI)The participants received sham tDCS current and participated in the Motor Imagery intervention.
MI/Sham tDCSSham tDCSThe participants received sham tDCS current and participated in the Motor Imagery intervention.
Primary Outcome Measures
NameTimeMethod
Prefrontal Cortical ActivityBaseline 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 InterventionsBaseline to 1 week follow up

number of sessions attended

Retention of ParticipantsBaseline to 1 week follow up

number of participants completing intervention and follow-up assessment

Adverse Events in Each Study ArmBaseline to 1 week follow up

Number of unexpected and/or serious adverse events

Time to CompletionBaseline to 1 week follow up

Recorded time to complete the obstacle course

Secondary Outcome Measures
NameTimeMethod
Kinesthetic and Visual Imagery Questionnaire (KVIQ)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.

Trial Locations

Locations (1)

Appalachian State University

🇺🇸

Boone, North Carolina, United States

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