Clinical trial NCT06414213: Improving Locomotor Learning With Brain Stimulation
Official title: Enhancing Locomotor Learning With Motor Imagery and Transcranial Direct Current Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motor Learning
Keywords: randomized
double-blinded
tDCS
motor imagery
functional near-infrared spectroscopy (fNIRS)
controlled trial
Lead sponsor: Appalachian State University
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Prefrontal Cortical Activity
timeFrame: Baseline to 1 week follow up
measure: Adherence to Interventions
timeFrame: Baseline to 1 week follow up
measure: Retention of Participants
timeFrame: Baseline to 1 week follow up
measure: Adverse Events in Each Study Arm
timeFrame: Baseline to 1 week follow up
measure: Time to Completion
timeFrame: Baseline to 1 week follow up
Secondary outcomes:
measure: Kinesthetic and Visual Imagery Questionnaire (KVIQ)
timeFrame: Baseline to 1 week follow up
Other outcomes:
Locations:
city: Boone
country: United States
facility: Appalachian State University
state: North Carolina
Study officials:
affiliation: Appalachian State University
name: Jared W Skinner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.