Trials / Enrolling By Invitation
Enrolling By InvitationNCT07327710
Non-Invasive Brain-Computer Interface Combined With Transcranial Electrical Stimulation for Peripheral Facial PalsyStimulation in the Treatment of Peripheral Facial Palsy
Efficacy and Safety of Non-Invasive Brain-Computer Interface Combined With Transcranial Electrical Stimulation in the Treatment of Peripheral Facial Palsy
- Status
- Enrolling By Invitation
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Nanjing Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Peripheral Facial Palsy
- Pulsed Radiofrequency
- Brain-Computer Interface
- Transcranial Direct Current Stimulation
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | 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. |
| 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. |
| OTHER | Standard Therapy | Includes facial muscle function training, physiotherapy, hot and cold compresses, and neurotrophic drug treatment. |
Timeline
- Start date
- 2025-11-30
- Primary completion
- 2027-12-31
- Completion
- 2028-12-31
- First posted
- 2026-01-08
- Last updated
- 2026-01-08
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07327710. Inclusion in this directory is not an endorsement.