Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414213
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2024-05-03
Brief Title:
Improving Locomotor Learning With Brain Stimulation
Sponsor:
Appalachian State University
Organization:
Appalachian State University
Study Overview
Official Title:
Enhancing Locomotor Learning With Motor Imagery and Transcranial Direct Current Stimulation
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELLMITS
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 111 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None