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Clinical Trials/NCT06414213
NCT06414213
Completed
Not Applicable

Enhancing Locomotor Learning With Motor Imagery and Transcranial Direct Current Stimulation

Appalachian State University1 site in 1 country38 target enrollmentSeptember 20, 2022
ConditionsMotor Learning

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Motor Learning
Sponsor
Appalachian State University
Enrollment
38
Locations
1
Primary Endpoint
Prefrontal Cortical Activity
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 20, 2022
End Date
December 22, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jared W Skinner

Assistant Professor

Appalachian State University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Kinesthetic and Visual Imagery Questionnaire (KVIQ)(Baseline to 1 week follow up)

Study Sites (1)

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