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

NCT07327710 | Enrolling By Invitation DMC

• 1 other identifier: [2025]YLJSA075
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Improvement in House-Brackmann (HB) grading

  At 0，2，4，8 and 12 weeks.

• Sunnybrook Facial Grading System score.

  At 0，2，4，8 and 12 weeks.

• Static and dynamic facial symmetry scores.

  At 0，2，4，8 and 12 weeks.

• Degree of facial muscle EMG activation and changes in EEG functional connectivity.

  At 0，2，4，8 and 12 weeks.

Secondary Outcomes (1)

• Adverse events

  At 0，2，4，8 and 12 weeks.

Study Arms (3)

Group A: Standard Therapy

PLACEBO COMPARATOR

Standard therapy.

Other: Standard Therapy

Group B: Pulsed Radiofrequency + Standard Therapy

PLACEBO COMPARATOR

Standard Therapy and Pulsed Radiofrequency Therapy.

Procedure: Pulsed Radiofrequency （PRF）; Other: Standard Therapy

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

EXPERIMENTAL

BCI + tDCS + Pulsed Radiofrequency Treatment + Standard Therapy.

Procedure: Brain-Computer Interface （BCI）; Procedure: Pulsed Radiofrequency （PRF）; Other: Standard Therapy

Interventions

Brain-Computer Interface （BCI） 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.

Also known as: transcranial Direct Current Stimulation （tDCS）

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

Pulsed Radiofrequency （PRF） 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.

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

Standard Therapy OTHER

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

Group A: Standard Therapy; Group B: Pulsed Radiofrequency + Standard Therapy; Group C：BCI + tDCS + Pulsed Radiofrequency Treatment + Standard Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

The Second Peoples's Hospital of Changzhou, the Third Affiliated Hospital of Nanjing Medical University

Changzhou, Jiangsu, 213000, China

Location

Related Publications (7)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018)" [Clin. Neurophysiol. 131 (2020) 474-528]. Clin Neurophysiol. 2020 May;131(5):1168-1169. doi: 10.1016/j.clinph.2020.02.003. Epub 2020 Feb 19. No abstract available.

  PMID: 32122766 RESULT

MeSH Terms

Interventions

Brain-Computer Interfaces; Transcranial Direct Current Stimulation; Standard of Care

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies; Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: phD

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 8, 2026
• Study Start: November 30, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)