Improving Locomotor Learning With Brain Stimulation

NCT06414213 | Completed Results FDA Device

• 1 other identifier: IRB-21-0198
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Motor Learning

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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

  Baseline to 1 week follow up

• Adherence to Interventions

  number of sessions attended

  Baseline to 1 week follow up

• Retention of Participants

  number of participants completing intervention and follow-up assessment

  Baseline to 1 week follow up

• Adverse Events in Each Study Arm

  Number of unexpected and/or serious adverse events

  Baseline to 1 week follow up

• Time to Completion

  Recorded time to complete the obstacle course

  Baseline to 1 week follow up

Secondary Outcomes (1)

• Kinesthetic and Visual Imagery Questionnaire (KVIQ)

  Baseline to 1 week follow up

Study Arms (3)

MI/Active tDCS

EXPERIMENTAL

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

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

MI/Sham tDCS

SHAM COMPARATOR

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

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

Control

NO INTERVENTION

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

Interventions

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.

MI/Active tDCS; MI/Sham tDCS

Active tDCS DEVICE

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

MI/Active tDCS

Sham tDCS DEVICE

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

MI/Sham tDCS

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Appalachian State University: lead

Study Sites (1)

Appalachian State University

Boone, North Carolina, 28607, United States

Location

Related Publications (2)

• 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.

  PMID: 32808403 BACKGROUND

• 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.

  PMID: 39799141 DERIVED

Results Point of Contact

• Title: Dr. Jared Skinner
• Organization: Appalachian State University

skinnerjw@appstate.edu

828-262-2512

Study Officials

• Jared W Skinner, PhD

  Appalachian State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 16, 2024
• Study Start: September 20, 2022
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: February 3, 2025
• Results First Posted: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)