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Not Yet Recruiting NCT07598175

Study on the Optimal Waveform Patterns of Electroacupuncture Targeted Intervention for Bell's Palsy Based on Surface Electromyography Characteristics

Conditions: Bell's Palsy

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 100
Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University

Summary

The goal of this clinical study is to find out whether different electronic acupuncture wave forms can effectively treat recovery-stage Bell's palsy in adults and evaluate their safety. The main questions it aims to answer are: * Can targeted electronic acupuncture wave forms improve facial nerve function in patients with Bell's palsy? * What is the optimal electronic acupuncture waveform for different degrees of facial nerve injury? * What adverse events may occur during electronic acupuncture treatment? Researchers will compare low-frequency continuous wave electronic acupuncture and intermittent wave electronic acupuncture to determine which waveform works better for recovery-stage Bell's palsy. Participants will: * Receive either low-frequency continuous wave electronic acupuncture or intermittent wave electronic acupuncture every other day for 4 weeks * Undergo surface sEMG and ENoG examinations at baseline, Week 2, and Week 4 * Complete facial function assessments and safety evaluations at each clinic visit

Eligibility Criteria

Inclusion Criteria for Bell's Palsy Subjects: * Meet the above Bell's palsy diagnostic criteria; * Age 18-65 years, either gender; * Disease course in recovery phase (21 days ≤ course ≤ 6 months) and not recovered (FNGS 2.0 score \>4); * Voluntarily participate in this study and sign informed consent. Inclusion Criteria for Healthy Subjects: * Do not meet the above Bell's palsy diagnostic criteria; * Age 18-65 years, either gender, matched to Bell's palsy subjects within 5 years for age and gender; * Normal facial nerve function, FNGS 2.0 score = 4; * Voluntarily participate in this study and sign informed consent. Exclusion Criteria for Bell's Palsy Subjects: * Facial trauma, skin lesions, or other diseases that may cause facial paralysis symptoms; * Diagnosed with Ramsay Hunt syndrome (herpes zoster oticus); * Bilateral facial paralysis; * Previous history of facial paralysis; * Facial synkinesis, contracture, or spasm already present; * History of facial surgery; * Uncontrolled diabetes, hypertension, severe cardiac, hepatic, or renal disease, cognitive impairment, aphasia, or mental disorders; * Pacemaker use; * Pregnant or lactating patients. Exclusion Criteria for Healthy Subjects: * Facial trauma, skin lesions, or other diseases that may affect facial muscle activity; * Previous history of facial paralysis; * History of facial surgery; * Uncontrolled diabetes, hypertension, severe cardiac, hepatic, or renal disease, cognitive impairment, aphasia, or mental disorders; * Pacemaker use; * Pregnant or lactating patients.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07598175). StuddyBuddy aggregates publicly available trial information.