Two Different Surgical Methods of Blepharospasm
Primary Purpose
Blepharospasm
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Facial nerve combing
Facial and Trigeminal nerve combing
Sponsored by
About this trial
This is an interventional treatment trial for Blepharospasm
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Facial nerve combing
Facial and Trigeminal nerve combing
Arm Description
Facial nerve combing and Microvascular Decompression(MVD) was performed in all the patients in this group.
Facial nerve combing、trigeminal nerve combing and Microvascular Decompression(MVD) was performed in all the patients in this group.
Outcomes
Primary Outcome Measures
Improvement of symptoms in patients with blepharospasm
Evaluation of patients with blepharospasm by rating scale.
Secondary Outcome Measures
Incidence of facial numbness
Incidence of facial paralysis
Full Information
NCT ID
NCT02765113
First Posted
April 14, 2016
Last Updated
May 4, 2016
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02765113
Brief Title
Two Different Surgical Methods of Blepharospasm
Official Title
Effect of Two Different Surgical Methods on the Prognosis of Patients With Blepharospasm
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharospasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Facial nerve combing
Arm Type
Active Comparator
Arm Description
Facial nerve combing and Microvascular Decompression(MVD) was performed in all the patients in this group.
Arm Title
Facial and Trigeminal nerve combing
Arm Type
Active Comparator
Arm Description
Facial nerve combing、trigeminal nerve combing and Microvascular Decompression(MVD) was performed in all the patients in this group.
Intervention Type
Procedure
Intervention Name(s)
Facial nerve combing
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Facial and Trigeminal nerve combing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement of symptoms in patients with blepharospasm
Description
Evaluation of patients with blepharospasm by rating scale.
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Incidence of facial numbness
Time Frame
up to 12 months
Title
Incidence of facial paralysis
Time Frame
up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Two Different Surgical Methods of Blepharospasm
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