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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
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blepharospasm

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

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

    First Posted
    April 14, 2016
    Last Updated
    May 4, 2016
    Sponsor
    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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    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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