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NCT Number: NCT07327710

Non-Invasive Brain-Computer Interface Combined With Transcranial Electrical Stimulation for Peripheral Facial PalsyStimulation 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).

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Key information

Conditions

Peripheral Facial Palsy Brain-Computer Interface Pulsed Radiofrequency Transcranial Direct Current Stimulation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Peoples's Hospital of Changzhou, the Third Affiliated Hospital of Nanjing Medical University

Changzhou, Jiangsu, 213000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brain-Computer Interface （BCI）

Procedure
  • 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.

  • 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）

Pulsed Radiofrequency （PRF）

Procedure

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.

Standard therapy

Other

Includes facial muscle function training, physiotherapy, hot and cold compresses, and neurotrophic drug treatment.

Primary outcomes

  1. Improvement in House-Brackmann (HB) grading

    Time frame: At 0，2，4，8 and 12 weeks.

  2. Sunnybrook Facial Grading System score.

    Time frame: At 0，2，4，8 and 12 weeks.

  3. Static and dynamic facial symmetry scores.

    Time frame: At 0，2，4，8 and 12 weeks.

  4. Degree of facial muscle EMG activation and changes in EEG functional connectivity.

    Time frame: At 0，2，4，8 and 12 weeks.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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