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

Official title

Efficacy and Safety of Non-Invasive Brain-Computer Interface Combined With Transcranial Electrical Stimulation in the Treatment of Peripheral Facial Palsy

Overview

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.

Interventions

• 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
• 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.

Primary outcome measures

• Improvement in House-Brackmann (HB) grading [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.]
• Static and dynamic facial symmetry scores. [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 outcome measures (1)

• Adverse events [Time frame: At 0，2，4，8 and 12 weeks.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Factorial

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The Second Peoples's Hospital of Changzhou, the Third Affiliated Hospital of Nanjing Medic — Changzhou

Publications

• Soekadar SR, Witkowski M, Birbaumer N, Cohen LG. Enhancing Hebbian Learning to Control Brain Oscillatory Activity. Cereb Cortex. 2015 Sep;25(9):2409-15. doi: 10.1093/cercor/bhu043. Epub 2014 Mar 13. PMID 24626608
• Jitsinthunun T, Li C, Ng TK, Zinboonyahgoon N. Pulsed Radiofrequency Treatment: Evidence for and Applications in Chronic Pain. Pain Physician. 2025 Nov;28(6):467-481. PMID 41337760
• Sam J, Catapano M, Sahni S, Ma F, Abd-Elsayed A, Visnjevac O. Pulsed Radiofrequency in Interventional Pain Management: Cellular and Molecular Mechanisms of Action - An Update and Review. Pain Physician. 2021 Dec;24(8):525-532. PMID 34793641
• Liu Z, Xie D, Wen X, Wang R, Yang Q, Liu H, Shao Y, Liu T. Peripheral Repetitive Transcranial Magnetic Stimulation(rTMS) for Idiopathic Facial Nerve Palsy: A Prospective, Randomized Controlled Trial. Neural Plast. 2022 Jul 13;2022:7536783. doi: 10.1155/2022/7536783. eCollection 2022. PMID 35875789
• Li D, Li R, Song Y, Qin W, Sun G, Liu Y, Bao Y, Liu L, Jin L. Effects of brain-computer interface based training on post-stroke upper-limb rehabilitation: a meta-analysis. J Neuroeng Rehabil. 2025 Mar 3;22(1):44. doi: 10.1186/s12984-025-01588-x. PMID 40033447
• Cervera MA, Soekadar SR, Ushiba J, Millan JDR, Liu M, Birbaumer N, Garipelli G. Brain-computer interfaces for post-stroke motor rehabilitation: a meta-analysis. Ann Clin Transl Neurol. 2018 Mar 25;5(5):651-663. doi: 10.1002/acn3.544. eCollection 2018 May. PMID 29761128
• Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Corrigendum to "Evidence-based PMID 32122766

Identifiers

NCT: NCT07327710 · [2025]YLJSA075

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗