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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2028-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A: Standard Therapy

Standard therapy.

Group Type PLACEBO_COMPARATOR

Standard Therapy

Intervention Type OTHER

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

Group B: Pulsed Radiofrequency + Standard Therapy

Standard Therapy and Pulsed Radiofrequency Therapy.

Group Type PLACEBO_COMPARATOR

Pulsed Radiofrequency （PRF）

Intervention Type 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

Intervention Type OTHER

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

Group C：BCI + tDCS + Pulsed Radiofrequency Treatment + Standard Therapy

BCI + tDCS + Pulsed Radiofrequency Treatment + Standard Therapy.

Group Type EXPERIMENTAL

Brain-Computer Interface （BCI）

Intervention Type 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）

Intervention Type 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

Intervention Type OTHER

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

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Standard Therapy

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

Intervention Type OTHER

Other Intervention Names

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transcranial Direct Current Stimulation （tDCS）

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No