Two Different Surgical Methods of Blepharospasm

Shanghai Jiao Tong University

Status and phase: Unknown; Early Phase 1

Conditions: Blepharospasm

Treatments: Procedure: Facial nerve combing; Procedure: Facial and Trigeminal nerve combing

Study type: Interventional

Funder types: Other

Identifiers

NCT02765113

XH-16-008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Facial nerve combing

Active Comparator group

Description:

Facial nerve combing and Microvascular Decompression(MVD) was performed in all the patients in this group.

Treatment:

Procedure: Facial nerve combing

Facial and Trigeminal nerve combing

Active Comparator group

Description:

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

Treatment:

Procedure: Facial and Trigeminal nerve combing