Efficacy and Safety of Non-Invasive Brain-Computer Interface Combined With Transcranial Electrical Stimulation in the Treatment of Peripheral Facial Palsy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement in House-Brackmann (HB) grading
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Group A: Standard Therapy
Standard therapy.
干预措施: Standard Therapy (Other)
Group B: Pulsed Radiofrequency + Standard Therapy
Standard Therapy and Pulsed Radiofrequency Therapy.
干预措施: Pulsed Radiofrequency （PRF） (Procedure)
Group B: Pulsed Radiofrequency + Standard Therapy
Standard Therapy and Pulsed Radiofrequency Therapy.
干预措施: Standard Therapy (Other)
Group C：BCI + tDCS + Pulsed Radiofrequency Treatment + Standard Therapy
BCI + tDCS + Pulsed Radiofrequency Treatment + Standard Therapy.
干预措施: Brain-Computer Interface （BCI） (Procedure)
Group C：BCI + tDCS + Pulsed Radiofrequency Treatment + Standard Therapy
BCI + tDCS + Pulsed Radiofrequency Treatment + Standard Therapy.
干预措施: Pulsed Radiofrequency （PRF） (Procedure)
Group C：BCI + tDCS + Pulsed Radiofrequency Treatment + Standard Therapy
BCI + tDCS + Pulsed Radiofrequency Treatment + Standard Therapy.
干预措施: Standard Therapy (Other)
结局指标
主要结局
Improvement in House-Brackmann (HB) grading
时间窗: At 0，2，4，8 and 12 weeks.
Static and dynamic facial symmetry scores.
时间窗: At 0，2，4，8 and 12 weeks.
Sunnybrook Facial Grading System score.
时间窗: At 0，2，4，8 and 12 weeks.
Degree of facial muscle EMG activation and changes in EEG functional connectivity.
时间窗: At 0，2，4，8 and 12 weeks.
次要结局
- Adverse events(At 0，2，4，8 and 12 weeks.)
研究者
Fang Liu
phD
Nanjing Medical University