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

NCT04939909 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-07-19

No results posted yet for this study

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.

Conditions

  • Blepharospasm

Interventions

DRUG

Botulinum toxin type A

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

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Juan Ye · Second Affiliated Hospital, School of Medicine, Zhejiang University

  • Huina Zhang · Second Affiliated Hospital, School of Medicine, Zhejiang University

  • Qi Gao · Second Affiliated Hospital, School of Medicine, Zhejiang University

  • Jiajun Xie · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-12
Primary Completion
2021-12-24
Completion
2022-07-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04939909 on ClinicalTrials.gov