Non-Invasive Brain-Computer Interface Combined With Transcranial Electrical Stimulation for Peripheral Facial PalsyStimulation in the Treatment of Peripheral Facial Palsy

December 25, 2025 updated by: Fang Liu, Nanjing Medical University

Efficacy and Safety of Non-Invasive Brain-Computer Interface Combined With Transcranial Electrical Stimulation in the Treatment of Peripheral Facial Palsy

To evaluate the efficacy and safety of treating peripheral facial palsy using a non-invasive brain-computer interface combined with transcranial direct current stimulation (tDCS).

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This study is mainly designed to compare the therapeutic efficacy of non-invasive brain-computer interface combined with transcranial direct current stimulation (tDCS), pulsed radiofrequency, and pharmacological treatment versus pulsed radiofrequency combined with pharmacological treatment in patients with peripheral facial palsy.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Changzhou, Jiangsu, China, 213000
        • The Second Peoples's Hospital of Changzhou, the Third Affiliated Hospital of Nanjing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Aged 18-70 years, regardless of sex.

Unilateral peripheral facial nerve palsy.

House-Brackmann (HB) grade II-VI.

Able to cooperate with target facial movement tasks and provide written informed consent, with intact cognitive function and good communication ability.

Good skin condition, with no severe skin lesions or facial skin grafts; no implanted electronic devices such as cardiac pacemakers or deep brain stimulators, to avoid electrophysiological interference.

Non-pregnant and non-lactating women, in accordance with regulatory requirements for minimal-risk research.

Exclusion Criteria:

Open facial wounds, active infections, significant skin lesions, or a history of severe allergy.

Severe cognitive impairment, psychiatric disorders, or inability to comply with study procedures.

Occurrence of serious adverse events or withdrawal at the patient's request.

Pregnant or lactating women, or patients unable to use appropriate contraceptive measures during the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group A: Standard Therapy
Standard therapy.
Other: Standard Therapy
Includes facial muscle function training, physiotherapy, hot and cold compresses, and neurotrophic drug treatment.
Placebo Comparator: Group B: Pulsed Radiofrequency + Standard Therapy
Standard Therapy and Pulsed Radiofrequency Therapy.
Other: Standard Therapy
Includes facial muscle function training, physiotherapy, hot and cold compresses, and neurotrophic drug treatment.
Procedure: Pulsed Radiofrequency （PRF）

Acute-phase "shock" protocol: Within 7 days of onset, a single pulsed radiofrequency treatment is applied to the extracranial segment of the facial nerve. Depending on recovery, the treatment may be repeated 1-2 weeks later.

Chronic-phase (sequelae) "shock" protocol: Administered once every 1-4 weeks, for a total of 1-4 sessions.
Experimental: Group C：BCI + tDCS + Pulsed Radiofrequency Treatment + Standard Therapy
BCI + tDCS + Pulsed Radiofrequency Treatment + Standard Therapy.
Other: Standard Therapy
Includes facial muscle function training, physiotherapy, hot and cold compresses, and neurotrophic drug treatment.
Procedure: Pulsed Radiofrequency （PRF）

Acute-phase "shock" protocol: Within 7 days of onset, a single pulsed radiofrequency treatment is applied to the extracranial segment of the facial nerve. Depending on recovery, the treatment may be repeated 1-2 weeks later.

Chronic-phase (sequelae) "shock" protocol: Administered once every 1-4 weeks, for a total of 1-4 sessions.

Procedure: Brain-Computer Interface （BCI）

  1. BCI Therapy:

    Real-time feedback drives NMES (neuromuscular electrical stimulation) of the target facial muscles.

    Each session lasts 30 minutes, 3-5 times per week, for a total of 4 weeks.

  2. tDCS Therapy: Applied to the regions corresponding to the branches of the facial nerve. A constant current (usually 0.5-2 mA) is delivered for 20-30 minutes per session, 5-20 sessions per course.

Standard treatment frequency is once daily, 5-6 times per week, with a continuous course of 2-4 weeks. Each stimulation session typically lasts 20-30 minutes.

Other Names:
  • transcranial Direct Current Stimulation （tDCS）

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in House-Brackmann (HB) grading
Time Frame: At 0，2，4，8 and 12 weeks.
At 0，2，4，8 and 12 weeks.
Sunnybrook Facial Grading System score.
Time Frame: At 0，2，4，8 and 12 weeks.
At 0，2，4，8 and 12 weeks.
Static and dynamic facial symmetry scores.
Time Frame: At 0，2，4，8 and 12 weeks.
At 0，2，4，8 and 12 weeks.
Degree of facial muscle EMG activation and changes in EEG functional connectivity.
Time Frame: At 0，2，4，8 and 12 weeks.
At 0，2，4，8 and 12 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: At 0，2，4，8 and 12 weeks.
Adverse events included skin tingling at the electrode site, mild fatigue, burning sensation, itching, headache, and a potential risk of seizure induction.
At 0，2，4，8 and 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

December 25, 2025

First Submitted That Met QC Criteria

December 25, 2025

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

December 25, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • [2025]YLJSA075

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared because the study involves sensitive clinical and neurophysiological data, and full de-identification cannot be guaranteed without compromising participant privacy. In addition, the informed consent obtained from participants did not include provisions for public data sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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