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A prospective, randomized, double-blind clinical study of two kinds of nerve substitution techniques in the treatment of peripheral facial paralysis

A prospective, randomized, double-blind clinical study of two kinds of nerve substitution techniques in the treatment of peripheral facial paralysis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034372
Enrollment
Unknown
Registered
2020-07-03
Start date
2020-07-01
Completion date
Unknown
Last updated
2020-07-06

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

Conditions

Facial paralysis

Interventions

Intervention group:Combination of both hypoglossal-facial nerve anastomosis and ansa cervicalis-hypoglossal nerve anastomosis
control group:Hypoglossal - facial nerve anastomosis

Sponsors

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Aged between 18-70 years, regardless of gender; (2) Meets the diagnostic criteria of "Peripheral Facial Paralysis" and the HB grade of facial paralysis is over Grade V; (3) If the anatomy continuity of patients' facial nerve is not interrupted, patients need underwent standardized conservative treatment for more than 6 months; (4) Before the operation, the amplitude of the electromyography on the affected side decreases by more than 70% compared with the healthy side; (5) The hypoglossal nerve function is normal; (6) Agree to participate in this topic and sign an informed letter.

Exclusion criteria

Exclusion criteria: (1) EMG indicates that the fibrillation potential disappears at rest, or the multiphase reaction potential cannot be induced during active exercise; (2) Patients with bilateral peripheral facial paralysis; (3) Patients with neurofibromatosis; (4) Patients with paralysis after poisoning and radiotherapy; (5) Severe systemic diseases such as circulation, breathing, blood, etc. are not suitable for general anesthesia; (6) Patients with mental illness; (7) Those who participated in other clinical trials within 3 months before the start of this study.

Design outcomes

Primary

MeasureTime frame
lingual atrophy grade ;

Secondary

MeasureTime frame
Tongue motor function score scale (ROM);Tongue disability index;Sunnybrook Score;Facial nerve evaluation system 2.0 (FNGS 2.0);17/5000 Nottingham facial nerve grading scale;FaCE scale;Neuroelectrophysiology;

Countries

China

Contacts

Public ContactShiting Li

Xinhua Hospital Affilated to Shanghai Jiaotong University School of Medicine

lishiting@xinhuamed.com.cn+86 021-25078001

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026