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

N/AEnrolling By InvitationNCT07327710

Nanjing Medical University30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Brain-Computer Interface （BCI）PROCEDURE

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.

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Changzhou, Jiangsu, China