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Not yet recruitingNCT07598175Updated Sep 2, 2026

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

An interventional study of electroacupuncture waveform in Bell's Palsy, sponsored by The Third Affiliated hospital of Zhejiang Chinese Medical University. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by The Third Affiliated hospital of Zhejiang Chinese Medical University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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
02

Conditions studied

  • Bell's Palsy

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03

In context

Bell Palsy

85 studies on the registry are indexed under Bell Palsy; 30 are open to participants now.

This study's planned enrollment of 100 is above the median of 42 across 70 interventional studies indexed under Bell Palsy.

Browse Bell Palsy studies →

Lead sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University is the lead sponsor of 45 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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 .

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Non-severe injury + Low-frequency continuous wave

    Procedure: electroacupuncture waveform

  • Experimental
    Non-severe injury + Interrupted wave

    Procedure: electroacupuncture waveform

  • Experimental
    Severe injury + Low-frequency continuous wave

    Procedure: electroacupuncture waveform

  • Experimental
    Severe injury + Interrupted wave

    Procedure: electroacupuncture waveform

Interventions

  • Procedureelectroacupuncture waveform

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: week4

Secondary outcomes

  1. Sunnybrook Facial Grading System,SBGS

    1.SBGS：Score range: 0-100, with higher scores indicating better facial nerve function.

    Time frame: week4

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2028, 24 months later.

Of 38 non-industry interventional studies with no phase under Bell Palsy, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 25. This study's planned 24 months is above that.

Counting every sponsor, half of 40 studies reached it within 10 months; a quarter within 3 and three quarters within 21.

How these figures are worked out, and which studies are left out of them.

Registered
May 6, 2026
First posted
May 20, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Sep 20, 2028
CompletionEst.
Nov 20, 2028
Last update
Sep 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07598175
Lead sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University
Responsible party
Jing Sun (Associate Professor, The Third Affiliated hospital of Zhejiang Chinese Medical University) — Principal investigator
First posted
May 20, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 20, 2028 (estimated)
Completion
Nov 20, 2028 (estimated)
Last update
Sep 2, 2026

Study contacts

Jing Sun
Contact
sunjing0268@163.com
13429610268

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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