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