Two Different Surgical Methods of Blepharospasm

Early Phase 1

• Conditions: Blepharospasm
• Interventions: Procedure: Facial and Trigeminal nerve combing; Procedure: Facial nerve combing

• Registration Number: NCT02765113
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

1. Background: Blepharospasm refers to orbital and periorbital orbicularis muscle spontaneous spasmodic contraction. Continuous spasm can be long or short, the performance of non spasm will strongly closed repeatedly. At present, the pathogenesis of blepharospasm is not clear, in addition, there is no particularly effective treatment.

2. Purpose：compare two different surgical methods, observe the improvement of symptoms and prognosis of patients with blepharospasm.

3. Scientific hypothesis: At present, the pathogenesis of blepharospasm is not clear, but clinical patients with blepharospasm showed bilateral eyelid twitching, eyes open difficulties and the symptoms are worse when tension, anxiety, insomnia, light stimulation and wind outside stimulation. At the same time, in the clinic，the investigators found that facial nerve and trigeminal nerve combing can improve the clinical symptoms of the patients. Therefore, the investigators speculated that over activity were related to clinical symptoms and corneal reflex pathway of blepharospasm patients.

4. Research content: the blepharospasm patients were randomly divided into two groups, prospective comparative analysis of two different surgical methods for the treatment of blepharospasm. One group of patients were performed facial nerve combing and microvascular decompression, the other group of patients were performed facial nerve, trigeminal nerve combing with microvascular decompression, to observation of postoperative clinical improvement of two groups of patients.

5. Expected results:To define a surgical method for the treatment of blepharospasm, and to promote the use of the academic and clinical practice.

Detailed Description

Background: Blepharospasm refers to orbital and periorbital orbicularis muscle spontaneous spasmodic contraction. Continuous spasm can be long or short, the performance of non spasm will strongly closed repeatedly. At present, the pathogenesis of blepharospasm is not clear, in addition, there is no particularly effective treatment.

Purpose：compare two different surgical methods, observe the improvement of symptoms and prognosis of patients with blepharospasm.

Scientific hypothesis: At present, the pathogenesis of blepharospasm is not clear, but clinical patients with blepharospasm showed bilateral eyelid twitching, eyes open difficulties and the symptoms are worse when tension, anxiety, insomnia, light stimulation and wind outside stimulation. At the same time, in the clinic，the investigators found that facial nerve and trigeminal nerve combing can improve the clinical symptoms of the patients. Therefore, the investigators speculated that over activity were related to clinical symptoms and corneal reflex pathway of blepharospasm patients.

Research content: the blepharospasm patients were randomly divided into two groups, prospective comparative analysis of two different surgical methods for the treatment of blepharospasm. One group of patients were performed facial nerve combing and microvascular decompression, the other group of patients were performed facial nerve, trigeminal nerve combing with microvascular decompression, to observation of postoperative clinical improvement of two groups of patients.

Expected results:To define a surgical method for the treatment of blepharospasm, and to promote the use of the academic and clinical practice.

Study Timeline

• Status Verified: 2016-04
• Study First Submitted: 2016-04-14
• Study Start: 2016-05
• Study First Submitted QC: 2016-05-04
• Last Update Submitted: 2016-05-04
• Study First Posted: 2016-05-06
• Last Update Posted: 2016-05-06
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients with bilateral blepharospasm
2. Clinical symptoms more than 1 years.
3. Patients who are willing to undergo surgery.
4. Preoperative patients who had not been treated with botulinum toxin.

Exclusion Criteria

1. Patients with serious heart and lung dysfunction can not tolerate surgery.
2. The clinical symptoms of the patients less than 1 years.
3. Patients who received local botulinum toxin treatment for a long time.
4. Patients with severe mental disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Facial and Trigeminal nerve combing	Facial and Trigeminal nerve combing	Facial nerve combing、trigeminal nerve combing and Microvascular Decompression(MVD) was performed in all the patients in this group.
Facial nerve combing	Facial nerve combing	Facial nerve combing and Microvascular Decompression(MVD) was performed in all the patients in this group.

Primary Outcome Measures

Name	Time	Method
Improvement of symptoms in patients with blepharospasm	up to 12 months	Evaluation of patients with blepharospasm by rating scale.

Secondary Outcome Measures

Name	Time	Method
Incidence of facial numbness	up to 12 months
Incidence of facial paralysis	up to 12 months