An interventional study of Brain-Computer Interface （BCI） and Pulsed Radiofrequency （PRF） in Peripheral Facial Palsy, Pulsed Radiofrequency and Brain-Computer Interface, sponsored by Nanjing Medical University. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Nanjing Medical University · Not applicable, Interventional, and Treatment
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).
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.
Nanjing Medical University is the lead sponsor of 169 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Standard therapy.
Other: Standard Therapy
Standard Therapy and Pulsed Radiofrequency Therapy.
Procedure: Pulsed Radiofrequency （PRF） · Other: Standard Therapy
BCI + tDCS + Pulsed Radiofrequency Treatment + Standard Therapy.
Procedure: Brain-Computer Interface （BCI） · Procedure: Pulsed Radiofrequency （PRF） · Other: Standard Therapy
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.
Also known as: transcranial Direct Current Stimulation （tDCS）
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.
Includes facial muscle function training, physiotherapy, hot and cold compresses, and neurotrophic drug treatment.
Improvement in House-Brackmann (HB) grading
Time frame: At 0，2，4，8 and 12 weeks.
Sunnybrook Facial Grading System score.
Time frame: At 0，2，4，8 and 12 weeks.
Static and dynamic facial symmetry scores.
Time frame: 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.
Adverse events
Adverse events included skin tingling at the electrode site, mild fatigue, burning sensation, itching, headache, and a potential risk of seizure induction.
Time frame: At 0，2，4，8 and 12 weeks.
Plan to share: No — 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.
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Nanjing Medical University