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Two Different Surgical Methods of Blepharospasm

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ClinicalTrials.gov Identifier: NCT02765113
Recruitment Status : Unknown
Verified April 2016 by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Not yet recruiting
First Posted : May 6, 2016
Last Update Posted : May 6, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Blepharospasm Procedure: Facial nerve combing Procedure: Facial and Trigeminal nerve combing Early Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Two Different Surgical Methods on the Prognosis of Patients With Blepharospasm
Study Start Date : May 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
Active Comparator: Facial nerve combing
Facial nerve combing and Microvascular Decompression(MVD) was performed in all the patients in this group.
Procedure: Facial nerve combing

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.


Active Comparator: Facial and Trigeminal nerve combing
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

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 Measures :
  1. Improvement of symptoms in patients with blepharospasm [ Time Frame: up to 12 months ]
    Evaluation of patients with blepharospasm by rating scale.


Secondary Outcome Measures :
  1. Incidence of facial numbness [ Time Frame: up to 12 months ]
  2. Incidence of facial paralysis [ Time Frame: up to 12 months ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Responsible Party: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02765113     History of Changes
Other Study ID Numbers: XH-16-008
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: May 6, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Blepharospasm
Eyelid Diseases
Eye Diseases