Bell's PalsyNCT07598175
Study on the Optimal Waveform Patterns of Electroacupuncture Targeted Intervention for Bell's Palsy Based on Surface Electromyography Characteristics
A study testing electroacupuncture waveform in people with Bell's Palsy, run by The Third Affiliated hospital of Zhejiang Chinese Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bell's Palsy
- What is being tested?
- electroacupuncture waveform
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 20 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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;
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- Uncontrolled diabetes, hypertension, severe cardiac, hepatic, or renal disease, cognitive impairment, aphasia, or mental disorders;
- Pacemaker use;
- Pregnant or lactating patients.
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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:
Read more
- 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
- Conditions
- Bell's Palsy
- Being tested
- electroacupuncture waveform
- Medical subject headings
- Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupuncture waveformProcedure or surgery
The non-severe injury group was randomly divided into two subgroups: one treated with low-frequency continuous wave and the other with intermittent wave.The severe injury group was also randomly divided into two subgroups: one treated with low-frequency continuous wave and the other with intermittent wave.
| Study group | Role | What they receive |
|---|---|---|
| Non-severe injury + Low-frequency continuous wave | Experimental | Not described Receives: Procedure: electroacupuncture waveform |
| Non-severe injury + Interrupted wave | Experimental | Not described Receives: Procedure: electroacupuncture waveform |
| Severe injury + Low-frequency continuous wave | Experimental | Not described Receives: Procedure: electroacupuncture waveform |
| Severe injury + Interrupted wave | Experimental | Not described Receives: Procedure: electroacupuncture waveform |
What is being measured
The primary outcome is the main question the study is designed to answer.
FNGS2.0
FNGS 2.0 stands for Facial Nerve Grading System 2.0, with a total score range of 4 to 24; lower scores indicate better facial nerve function (4 = normal), while higher scores indicate more severe facial paralysis (24 = complete facial palsy).
Measured: week4
Secondary outcomes (1)
Sunnybrook Facial Grading System,SBGS
1.SBGS：Score range: 0-100, with higher scores indicating better facial nerve function.
Measured: week4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start1 Sep 2026 (estimated)
- Primary completion20 Sep 2028 (estimated)
- Study completion20 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bell's PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Sun, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598175
- Sponsor's protocol ID
- GZY-KJS-ZJ-2026-056
- Status last verified
- Jun 2026
- First submitted
- 6 May 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Optimal Waveform Patterns of Electroacupuncture Targeted Intervention for Bell's Palsy Based on Surface Electromyography Characteristics
- ClinicalTrials.gov ID
- NCT07598175
- Acronym / sponsor ID
- GZY-KJS-ZJ-2026-056
- Conditions
- Bell's Palsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 20 Sep 2028 (estimated)
- Study completion
- 20 Nov 2028 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-severe injury + Low-frequency continuous wave | Experimental | Procedure: electroacupuncture waveform |
| Non-severe injury + Interrupted wave | Experimental | Procedure: electroacupuncture waveform |
| Severe injury + Low-frequency continuous wave | Experimental | Procedure: electroacupuncture waveform |
| Severe injury + Interrupted wave | Experimental | Procedure: electroacupuncture waveform |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- Do not meet the above Bell's palsy diagnostic criteria;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electroacupuncture waveformThe non-severe injury group was randomly divided into two subgroups: one treated with low-frequency continuous wave and the other with intermittent wave.The severe injury group was also randomly divided into two subgroups: one treated with low-frequency continuous wave and the other with intermittent wave. | Procedure or surgery | Non-severe injury + Interrupted wave, Non-severe injury + Low-frequency continuous wave, Severe injury + Interrupted wave, Severe injury + Low-frequency continuous wave |
Primary outcome
FNGS2.0
Time frame: week4
FNGS 2.0 stands for Facial Nerve Grading System 2.0, with a total score range of 4 to 24; lower scores indicate better facial nerve function (4 = normal), while higher scores indicate more severe facial paralysis (24 = complete facial palsy).
1 secondary outcome
Sunnybrook Facial Grading System,SBGS
Time frame: week4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture waveform in people with Bell's Palsy, run by The Third Affiliated hospital of Zhejiang Chinese Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Sun (13429610268, sunjing0268@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FNGS2.0 (time frame: week4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.