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临床试验/NCT04939909
NCT04939909Unknown早期 1 期

Botulinum Toxin Relieves Anxiety, Depression and Sleep Disorderes in Patients With Blepharospasm

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年7月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
发起方
入组人数
50
试验地点
1
主要终点
Change from baseline blepharospasm evaluation at 3 months

研究概览

简要总结

Blepharospasm (BSP) is a chronic, idiopathic, recurrent and progressive disease, which mostly occurs in both eyes. It is mainly manifested as involuntary spasm of muscles around the eyes, leading to uncontrollable narrowing or even closure of blepharospasm. Although there is no pain in BSP patients, it can cause social or psychological dysfunction, make patients feel difficult in driving, reading and working, and seriously affect the social, work and life of patients.

Depression and anxiety are common and harmful mental disorders. At present, less than 40% of patients with depression can get effective treatment. Using simple and effective screening tools can effectively improve the detection rate of depression, so that patients can get timely and effective treatment. It is also an effective measure to prevent suicide.

Botulinum toxin type A (BTX-A) has achieved gratifying results in the treatment of dyskinesia. It has been confirmed that BTX-A has a significant effect on BSP. The effective rate is 70% - 90%. About 50% of the patients can regain normal or near normal visual function. At present, no prospective studies have explored this association between blepharospasm and depression / anxiety, and whether BTX-A can improve this mood disorder. Therefore, our research goal is to further study the relationship between blepharospasm and depression / anxiety, sleep in a prospective way, and to determine whether BTX-A treatment will affect depression / anxiety symptoms, so as to provide more theoretical basis for clinical treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with blepharospasm who received botulinum toxin injection therapy
  • All patients must have had the symptoms of blepharospasm for over six months

排除标准

  • Age-related macular degeneration
  • Visual acuity of 20/200 or worse
  • Chronic obstructive pulmonary disease
  • Cardio cerebral diseases, psychosis
  • Loss of limb
  • Connective tissue diseases
  • Dialysis dependence
  • Anyone who was unable to cooperate with the examinations

研究组 & 干预措施

Patients treated with Botulinum toxin type A

Other

Patients were treated with Botulinum toxin type A

干预措施: Botulinum toxin type A (Drug)

结局指标

主要结局

Change from baseline blepharospasm evaluation at 3 months

时间窗: Through study completion, 3 months.

Patients will evaluated the Jankovic Rating scale (JRS),the total score of JRS is 8, and a change of 2 points in the JRS is clinically meaningful.

次要结局

  • Change from baseline anxiety evaluation at 3 months(Through study completion, 3 months.)
  • Change from baseline depression evaluation at 3 months(Through study completion, 3 months.)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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