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Research on the Application of a Closed-loop Facial Nerve Electrical Stimulation System Based on TENG Sensors for Alleviating Hemifacial Spasm

Research on the Application of a Closed-loop Facial Nerve Electrical Stimulation System Based on TENG Sensors for Alleviating Hemifacial Spasm

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110009
Enrollment
Unknown
Registered
2025-09-28
Start date
2025-10-09
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemifacial spasm

Interventions

Intervention group:Based on the experimental spasm recognition model, when the TENG sensor detects facial muscle spasms, it initiates closed-loop electrical stimulation of the facial nerve.
Healthy control group:No

Sponsors

Tsinghua University Yuquan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 70 years (inclusive); 2. No restrictions on gender; 3. Diagnosis of moderate to severe primary hemifacial spasm (HFS), with a disease duration of at least 6 months and clinically stable symptoms; 4. Prior inadequate response to botulinum toxin injections, or patient refusal/intolerance to repeated injections, or contraindication/unwillingness to undergo microvascular decompression surgery; 5. Ability to comprehend the study procedures and provide voluntary informed consent; 6. Absence of implanted electronic medical devices (e.g., cardiac pacemakers), with intact facial skin and no open wounds or active infections; 7. Capacity to comply with the use of electro-stimulation glasses and complete all scheduled follow-up assessments.

Exclusion criteria

Exclusion criteria: 1. Refusal to sign the informed consent form or poor compliance; 2. Secondary hemifacial spasm (such as due to tumors, brainstem vascular lesions, etc.) or coexisting with other neurological disorders (such as epilepsy, Parkinson's disease, post-stroke sequelae, etc.); 3. Having participated in other interventional clinical trials within the recent 90 days (before the start of the study); 4. Having undergone facial nerve surgery or having any facial electrical stimulation device implanted; 5. Presence of severe dermatitis, infection, ulceration or skin lesions on the face that are not suitable for electrode placement; 6. Comorbid with severe cardiovascular disorders (such as recent myocardial infarction, refractory arrhythmia) or having an implanted cardiac electronic device; 7. Suffering from severe mental disorders (severe depression, schizophrenia, etc.) or cognitive dysfunction, unable to complete objective assessment; 8. Pregnant women or breastfeeding women, or planning to get pregnant during the study period; 9. Other situations that the researchers consider unsuitable for participating in this study (such as severe visual impairment affecting video assessment, inability to tolerate electrical stimulation, etc.).

Design outcomes

Primary

MeasureTime frame
Facial Skin Movement Signals ;Facial Electromyography (EMG) Data ;Video surveillance footage;Eye-tracking data;

Secondary

MeasureTime frame
Patient Self-Assessment Scale;

Countries

China

Contacts

Public ContactJinting Wu

Tsinghua University Yuquan Hospital

75510218@qq.com+86 152 1005 8656

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026