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

Blepharospasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04939909
• Other study ID #: 2020-487
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 12, 2021
• Est. completion date: July 15, 2022

Study information

• Verified date: July 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Juan Ye
• Phone: 057187783897
• Email: yejuan[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 15, 2022
• Est. primary completion date: December 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Blepharospasm

Intervention

Drug:
• Botulinum toxin type A
Patients were treated with Botulinum toxin type A applications on the Orbicularis oculi and glabellar complex

Locations

Country	Name	City	State
China	Juan Ye	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline sleep disorders evaluation at 3 months	Patients will evaluated the Athens insomnia scale (AIS) questionnaires, the severity criteria of the AIS are capable of categorizing insomnia severity as follows: absence of insomnia (0-5), mild insomnia (6-9), moderate insomnia (10-15), and severe insomnia (16-24).	Through study completion, 3 months.
Primary	Change from baseline blepharospasm evaluation at 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.	Through study completion, 3 months.
Secondary	Change from baseline depression evaluation at 3 months	Patients will evaluated the personal Health Questionnaire Depression Scale (PHQ-8) with a total score of 24, cut-points of 5, 10, and 15 represent mild, moderate, and severe levels of depressive symptoms.	Through study completion, 3 months.
Secondary	Change from baseline anxiety evaluation at 3 months	Patients will evaluated the Generalized Anxiety Disorder 7-item scale (GAD-7) questionnaires with a total score of 21, cut-points of 5, 10, and 15 represent mild, moderate, and severe levels of anxiety symptoms.	Through study completion, 3 months.