Clinical trial NCT04939909: Botulinum Toxin Relieves Anxiety, Depression and Sleep Disorderes in Patients With Blepharospasm
Official title: Botulinum Toxin Relieves Anxiety, Depression and Sleep Disorderes in Patients With Blepharospasm
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Blepharospasm
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline blepharospasm evaluation at 3 months
timeFrame: Through study completion, 3 months.
Secondary outcomes:
measure: Change from baseline depression evaluation at 3 months
timeFrame: Through study completion, 3 months.
measure: Change from baseline anxiety evaluation at 3 months
timeFrame: Through study completion, 3 months.
Other outcomes:
measure: Change from baseline sleep disorders evaluation at 3 months
timeFrame: Through study completion, 3 months.
Locations:
city: Hangzhou
country: China
facility: Juan Ye
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Juan Ye
role: STUDY_CHAIR
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Huina Zhang
role: STUDY_DIRECTOR
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Qi Gao
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Jiajun Xie
role: PRINCIPAL_INVESTIGATOR
References: