Peripheral Facial PalsyNCT07327710
Non-Invasive Brain-Computer Interface Combined With Transcranial Electrical Stimulation for Peripheral Facial PalsyStimulation in the Treatment of Peripheral Facial Palsy
A study testing Brain-Computer Interface （BCI）, Pulsed Radiofrequency （PRF） and Standard Therapy in people with Peripheral Facial Palsy and Pulsed Radiofrequency, run by Nanjing Medical University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peripheral Facial Palsy, Pulsed Radiofrequency, Brain-Computer Interface
- What is being tested?
- Brain-Computer Interface （BCI）, Pulsed Radiofrequency （PRF） and Standard Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Peoples's Hospital of Changzhou, the Third Affiliated Hospital of Nanjing Medical University
Changzhou, Jiangsu, 213000
About this study
Official title: Efficacy and Safety of Non-Invasive Brain-Computer Interface Combined With Transcranial Electrical Stimulation in the Treatment of Peripheral Facial Palsy
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).
Read the 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
- Being tested
- Brain-Computer Interface （BCI）, Pulsed Radiofrequency （PRF）, Standard Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain-Computer Interface （BCI）Procedure or surgery
Also called transcranial Direct Current Stimulation （tDCS）
- 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.
- 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.
Pulsed Radiofrequency （PRF）Procedure or surgery
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.
Standard TherapyOther
Includes facial muscle function training, physiotherapy, hot and cold compresses, and neurotrophic drug treatment.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Standard Therapy | Placebo comparator | Standard therapy. Receives: Other: Standard Therapy |
| Group B: Pulsed Radiofrequency + Standard Therapy | Placebo comparator | Standard Therapy and Pulsed Radiofrequency Therapy. Receives: Procedure: Pulsed Radiofrequency （PRF）; Other: Standard Therapy |
| Group C：BCI + tDCS + Pulsed Radiofrequency Treatment + Standard Therapy | Experimental | BCI + tDCS + Pulsed Radiofrequency Treatment + Standard Therapy. Receives: Procedure: Brain-Computer Interface （BCI）; Procedure: Pulsed Radiofrequency （PRF）; Other: Standard Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in House-Brackmann (HB) grading
Measured: At 0，2，4，8 and 12 weeks.
Sunnybrook Facial Grading System score.
Measured: At 0，2，4，8 and 12 weeks.
Static and dynamic facial symmetry scores.
Measured: At 0，2，4，8 and 12 weeks.
Degree of facial muscle EMG activation and changes in EEG functional connectivity.
Measured: At 0，2，4，8 and 12 weeks.
Secondary outcomes (1)
Adverse events
Adverse events included skin tingling at the electrode site, mild fatigue, burning sensation, itching, headache, and a potential risk of seizure induction.
Measured: At 0，2，4，8 and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start30 Nov 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Peripheral Facial PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Liu, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327710
- Sponsor's protocol ID
- [2025]YLJSA075
- Status last verified
- Dec 2025
- First submitted
- 25 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared because the study involves sensitive clinical and neurophysiological data, and full de-identification cannot be guaranteed without compromising participant privacy. In addition, the informed consent obtained from participants did not include provisions for public data sharing.
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.
PubMed 24626608Jitsinthunun 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.
PubMed 41337760Sam 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.
PubMed 34793641Liu 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.
PubMed 35875789Li 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.
PubMed 40033447Cervera 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.
PubMed 29761128Lefaucheur 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.
PubMed 32122766
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Non-Invasive Brain-Computer Interface Combined With Transcranial Electrical Stimulation in the Treatment of Peripheral Facial Palsy
- ClinicalTrials.gov ID
- NCT07327710
- Acronym / sponsor ID
- [2025]YLJSA075
- Conditions
- Peripheral Facial Palsy, Pulsed Radiofrequency, Brain-Computer Interface, Transcranial Direct Current Stimulation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 30 Nov 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Standard Therapy | Placebo comparator | Other: Standard TherapyStandard therapy. |
| Group B: Pulsed Radiofrequency + Standard Therapy | Placebo comparator | Procedure: Pulsed Radiofrequency （PRF）, Other: Standard TherapyStandard Therapy and Pulsed Radiofrequency Therapy. |
| Group C：BCI + tDCS + Pulsed Radiofrequency Treatment + Standard Therapy | Experimental | Procedure: Brain-Computer Interface （BCI）, Procedure: Pulsed Radiofrequency （PRF）, Other: Standard TherapyBCI + tDCS + Pulsed Radiofrequency Treatment + Standard Therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain-Computer Interface （BCI）Also: transcranial Direct Current Stimulation （tDCS）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 or surgery | Group C：BCI + tDCS + Pulsed Radiofrequency Treatment + Standard Therapy |
| 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. | Procedure or surgery | Group B: Pulsed Radiofrequency + Standard Therapy, Group C：BCI + tDCS + Pulsed Radiofrequency Treatment + Standard Therapy |
| Standard TherapyIncludes facial muscle function training, physiotherapy, hot and cold compresses, and neurotrophic drug treatment. | Other | Group A: Standard Therapy, Group B: Pulsed Radiofrequency + Standard Therapy, Group C：BCI + tDCS + Pulsed Radiofrequency Treatment + Standard Therapy |
Primary outcome
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.
1 secondary outcome
Adverse events
Time frame: At 0，2，4，8 and 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Results publication: PubMed 24626608Soekadar 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.
- Results publication: PubMed 41337760Jitsinthunun 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.
- Results publication: PubMed 34793641Sam 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.
- Results publication: PubMed 35875789Liu 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.
- Results publication: PubMed 40033447Li 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.
- Results publication: PubMed 29761128Cervera 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.
- Results publication: PubMed 32122766Lefaucheur 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.
- Individual participant dataSharing planned: No. IPD will not be shared because the study involves sensitive clinical and neurophysiological data, and full de-identification cannot be guaranteed without compromising participant privacy. In addition, the informed consent obtained from participants did not include provisions for public data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain-Computer Interface （BCI）, Pulsed Radiofrequency （PRF） and Standard Therapy in people with Peripheral Facial Palsy and Pulsed Radiofrequency, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in House-Brackmann (HB) grading (time frame: At 0，2，4，8 and 12 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07327710, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026; AzTrials last refreshed its copy on 29 Oct 2026.