Changes in Brain-Muscle Coupling After Microneedle-Knife Therapy for Ankle Sprain
Changes in Corticomuscular Coupling After Microneedle-Knife Therapy in Patients With Ankle Sprain: An EEG-EMG caCOH Analysis
1 other identifier
interventional
11
1 country
1
Brief Summary
This study evaluated changes in brain-muscle coordination in patients with ankle sprain after one session of microneedle-knife therapy. Microneedle-knife therapy is a minimally invasive treatment applied to soft tissues related to the lower leg and foot. Eleven participants completed electroencephalography (EEG) and electromyography (EMG) recordings before and after treatment. During each recording, participants performed ankle dorsiflexion, eversion, and inversion or isometric contraction tasks. The primary analysis examined corticomuscular coupling, which reflects coordination between activity in motor-related brain regions and lower-limb muscles, particularly within the beta frequency band of 15 to 30 Hz.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
CompletedFirst Submitted
Initial submission to the registry
September 19, 2026
CompletedFirst Posted
Study publicly available on registry
September 24, 2026
CompletedSeptember 24, 2026
September 1, 2026
Same day
September 19, 2026
September 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Pre-Treatment in Mean Beta-Band Corticomuscular Coupling Measured by caCOH
Mean caCOH within the beta frequency band of 15 to 30 Hz was calculated from synchronized EEG and EMG recordings for each participant during ankle dorsiflexion, eversion, and inversion or isometric contraction tasks. The primary analysis focused on motor-related EEG channels C3 and C4 and task-relevant lower-limb muscles. Change in caCOH was calculated as the post-treatment value minus the pre-treatment value. A positive change indicates increased corticomuscular coupling after treatment.
Baseline and immediately after the single microneedle-knife therapy session
Study Arms (1)
Microneedle-Knife Therapy
EXPERIMENTALOne session of microneedle-knife therapy was administered to soft-tissue regions related to the affected lower leg and foot. No other therapeutic intervention was administered as part of the study during the treatment period.
Interventions
One session of microneedle-knife therapy was administered to soft-tissue regions related to the affected lower leg and foot. No other therapeutic intervention was administered as part of the study during the treatment period.
Eligibility Criteria
You may qualify if:
- Clinically diagnosed ankle sprain.
- Able to perform ankle dorsiflexion, eversion, and inversion or isometric contraction tasks according to the researchers' instructions.
- Able to complete synchronous EEG and EMG recordings before and after treatment.
- Willing to participate and able to provide written informed consent.
You may not qualify if:
- Severe neurological disease, osteoarticular disease, or another condition affecting lower-limb motor control.
- Severe cognitive impairment, impaired auditory comprehension, or inability to follow the experimental instructions.
- Recent receipt of another therapeutic intervention that could substantially affect lower-limb motor function.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Affiliated Dongyang Hospital of Wenzhou Medical University, Dongyang, Zhejiang, China
Dongyang, Zhejiang, 322100, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Chief Physician
Study Record Dates
First Submitted
September 19, 2026
First Posted
September 24, 2026
Study Start
January 1, 2023
Primary Completion
January 1, 2023
Study Completion
June 1, 2026
Last Updated
September 24, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share