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NCT Number: NCT07839260

Changes in Brain-Muscle Coupling After Microneedle-Knife Therapy for Ankle Sprain

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Affiliated Dongyang Hospital of Wenzhou Medical University, Dongyang, Zhejiang, China

Dongyang, Zhejiang, 322100, China

About this study

This was a single-group, pre-post interventional study involving participants with ankle sprain. Each participant received one session of microneedle-knife therapy targeting relevant soft-tissue regions of the lower leg and foot. No other therapeutic intervention was administered as part of the study during the treatment period.

Synchronous EEG and EMG recordings were performed before and after microneedle-knife therapy. EEG signals were recorded using a NeuSen W64 wireless EEG acquisition system at a sampling frequency of 1,000 Hz. EMG signals were recorded using a Trigno Wireless EMG System. A common trigger was used to temporally align the EEG and EMG signals.

The motor assessment included three ankle tasks: dorsiflexion, eversion, and inversion or isometric contraction. Participants performed the tasks while seated and began each movement after an instruction from the researcher. Each movement lasted approximately 3 seconds and was repeated at least five times. A 1-minute rest period was provided between tasks to reduce fatigue. The tasks were performed in a fixed order: dorsiflexion, eversion, and inversion or isometric contraction.

EEG signals from frontal, central, and parietal scalp regions were analyzed, with particular attention to the motor-related C3, C4, and Cz channels. EMG signals were recorded from the tibialis anterior, peroneus longus, extensor digitorum longus, medial gastrocnemius, lateral gastrocnemius, and soleus muscles.

For each movement event, the signal segment from 0.5 to 2.0 seconds after the movement instruction was used for analysis. Corticomuscular coupling was assessed using the covariance-based coherence (caCOH) index. The principal analysis focused on mean caCOH within the beta frequency band of 15 to 30 Hz and compared measurements obtained before and after treatment across the three ankle motor tasks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Microneedle-Knife Therapy

Procedure

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.

Primary outcomes

  1. Change From Pre-Treatment in Mean Beta-Band Corticomuscular Coupling Measured by caCOH

    Time frame: Baseline and immediately after the single microneedle-knife therapy session

    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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Affiliated Dongyang Hospital of Wenzhou Medical University

Other

Collaborators

  • Hangzhou Dianzi University

Registry information

Official study title

Changes in Corticomuscular Coupling After Microneedle-Knife Therapy in Patients With Ankle Sprain: An EEG-EMG caCOH Analysis

Important dates

Study start
2023
Primary completion
2023
Study completion
2026
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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