NCT07598175

Brief 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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
31mo left

Started May 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
May 2026Nov 2028

First Submitted

Initial submission to the registry

May 6, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

May 15, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2028

Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

2.4 years

First QC Date

May 6, 2026

Last Update Submit

May 19, 2026

Conditions

Bell's Palsy

Outcome Measures

Primary Outcomes (1)

  • FNGS2.0

    week4

Secondary Outcomes (1)

  • Sunnybrook Facial Grading System,SBGS

    week4

Study Arms (4)

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

Interventions

electroacupuncture waveformPROCEDURE

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.

Non-severe injury + Interrupted waveNon-severe injury + Low-frequency continuous waveSevere injury + Interrupted waveSevere injury + Low-frequency continuous wave

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bell Palsy

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsMouth DiseasesStomatognathic DiseasesFacial Nerve DiseasesCranial Nerve DiseasesNervous System Diseases

Central Study Contacts

Jing Sun

CONTACT

13429610268sunjing0268@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 6, 2026

First Posted

May 20, 2026

Study Start

May 15, 2026

Primary Completion (Estimated)

September 20, 2028

Study Completion (Estimated)

November 20, 2028

Last Updated

May 20, 2026

Record last verified: 2026-05