Brain-Computer Interface, Peripheral Facial Palsy, Pulsed Radiofrequency, Transcranial Direct Current Stimulation
Conditions
Brief summary
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).
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.
Interventions
PROCEDUREBrain-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.
PROCEDUREPulsed 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.
OTHERStandard Therapy
Includes facial muscle function training, physiotherapy, hot and cold compresses, and neurotrophic drug treatment.
Sponsors
Nanjing Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Static and dynamic facial symmetry scores. | At 0，2，4，8 and 12 weeks. |
| Degree of facial muscle EMG activation and changes in EEG functional connectivity. | At 0，2，4，8 and 12 weeks. |
| Improvement in House-Brackmann (HB) grading | At 0，2，4，8 and 12 weeks. |
| Sunnybrook Facial Grading System score. | At 0，2，4，8 and 12 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 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. |
Countries
China
Outcome results
None listed