Efficacy and Safety of Non-Invasive Brain-Computer Interface Combined With Transcranial Electrical Stimulation in the Treatment of Peripheral Facial Palsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Improvement in House-Brackmann (HB) grading
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Group A: Standard Therapy
Standard therapy.
Intervention: Standard Therapy (Other)
Group B: Pulsed Radiofrequency + Standard Therapy
Standard Therapy and Pulsed Radiofrequency Therapy.
Intervention: Pulsed Radiofrequency （PRF） (Procedure)
Group B: Pulsed Radiofrequency + Standard Therapy
Standard Therapy and Pulsed Radiofrequency Therapy.
Intervention: Standard Therapy (Other)
Group C：BCI + tDCS + Pulsed Radiofrequency Treatment + Standard Therapy
BCI + tDCS + Pulsed Radiofrequency Treatment + Standard Therapy.
Intervention: Brain-Computer Interface （BCI） (Procedure)
Group C：BCI + tDCS + Pulsed Radiofrequency Treatment + Standard Therapy
BCI + tDCS + Pulsed Radiofrequency Treatment + Standard Therapy.
Intervention: Pulsed Radiofrequency （PRF） (Procedure)
Group C：BCI + tDCS + Pulsed Radiofrequency Treatment + Standard Therapy
BCI + tDCS + Pulsed Radiofrequency Treatment + Standard Therapy.
Intervention: Standard Therapy (Other)
Outcomes
Primary Outcomes
Improvement in House-Brackmann (HB) grading
Time Frame: At 0，2，4，8 and 12 weeks.
Static and dynamic facial symmetry scores.
Time Frame: At 0，2，4，8 and 12 weeks.
Sunnybrook Facial Grading System score.
Time Frame: At 0，2，4，8 and 12 weeks.
Degree of facial muscle EMG activation and changes in EEG functional connectivity.
Time Frame: At 0，2，4，8 and 12 weeks.
Secondary Outcomes
- Adverse events(At 0，2，4，8 and 12 weeks.)
Investigators
Fang Liu
phD
Nanjing Medical University