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

Zhejiang University

Status and phase: Unknown; Early Phase 1

Conditions: Blepharospasm

Treatments: Drug: Botulinum toxin type A

Study type: Interventional

Funder types: Other

Identifiers

NCT04939909

2020-487

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Glaucoma
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Patients treated with Botulinum toxin type A

Other group

Description:

Patients were treated with Botulinum toxin type A

Treatment:

Drug: Botulinum toxin type A