An Early Phase 1 interventional study of Facial nerve combing and Facial and Trigeminal nerve combing in Blepharospasm, sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Status unknown. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-05-06.
Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Early Phase 1, Interventional, and Treatment
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.
42 studies on the registry are indexed under Blepharospasm; 1 is open to participants now.
This study's planned enrollment of 40 is close to the median of 40 across 28 interventional studies indexed under Blepharospasm.
Browse Blepharospasm studies →Xinhua Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 225 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
Facial nerve combing and Microvascular Decompression(MVD) was performed in all the patients in this group.
Procedure: Facial 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. MVD: explore the facial nerve and trigeminal nerve and then perform microvascular decompression.
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.
Improvement of symptoms in patients with blepharospasm
Evaluation of patients with blepharospasm by rating scale.
Time frame: up to 12 months
Incidence of facial numbness
Time frame: up to 12 months
Incidence of facial paralysis
Time frame: up to 12 months
No study locations are listed for this record.
Plan to share: Yes
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine →