Two Different Surgical Methods of Blepharospasm

NCT02765113 | Unknown Early Phase 1 DMC

• 1 other identifier: XH-16-008
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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. 2.Purpose：compare two different surgical methods, observe the improvement of symptoms and prognosis of patients with blepharospasm.
3. 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. 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. 5.Expected results:To define a surgical method for the treatment of blepharospasm, and to promote the use of the academic and clinical practice.

Conditions

Blepharospasm

Outcome Measures

Primary Outcomes (1)

• Improvement of symptoms in patients with blepharospasm

  Evaluation of patients with blepharospasm by rating scale.

  up to 12 months

Secondary Outcomes (2)

• Incidence of facial numbness

  up to 12 months

• Incidence of facial paralysis

  up to 12 months

Study Arms (2)

Facial nerve combing

ACTIVE COMPARATOR

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

Procedure: Facial nerve combing

Facial and Trigeminal nerve combing

ACTIVE COMPARATOR

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

Procedure: Facial and Trigeminal nerve combing

Interventions

Facial nerve combing PROCEDURE

Facial nerve combing:To sort out the facial nerve using the nerve combing knife. MVD: explore the facial nerve and trigeminal nerve and then perform microvascular decompression.

Facial nerve combing

Facial and Trigeminal nerve combing PROCEDURE

Facial nerve combing:To sort out the facial nerve using the nerve combing knife. Trigeminal nerve combing:To sort out the trigeminal nerve using the nerve combing knife. MVD: explore the facial nerve and trigeminal nerve and then perform microvascular decompression.

Facial and Trigeminal nerve combing

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

MeSH Terms

Conditions

Blepharospasm

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: May 6, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 6, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share