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Clinical Trials in China / NCT07327710
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Non-Invasive Brain-Computer Interface Combined With Transcranial Electrical Stimulation for Peripheral Facial PalsyStimulation in the Treatment of Peripheral Facial Palsy

NCT07327710 · tracked via the Priya Life Science China tracker
Sponsor
Nanjing Medical University
Phase
Not applicable
Started
2025-11-30
Last updated
2026-01-08

Condition(s) studied

Peripheral Facial PalsyPulsed RadiofrequencyBrain-Computer InterfaceTranscranial Direct Current Stimulation

Investigational drug(s) / intervention(s)

Brain-Computer Interface (BCI)Pulsed Radiofrequency (PRF)Standard Therapy

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.

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.

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

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
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.

Primary outcome measure(s)

Trial sites (1)

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07327710 on ClinicalTrials.gov ↗ ← All trials in China