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

NCT04939909 | Unknown Early Phase 1

• 1 other identifier: 2020-487
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Blepharospasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from baseline depression evaluation at 3 months

  Through study completion, 3 months.

• Change from baseline anxiety evaluation at 3 months

  Through study completion, 3 months.

Other Outcomes (1)

• Change from baseline sleep disorders evaluation at 3 months

  Through study completion, 3 months.

Study Arms (1)

Patients treated with Botulinum toxin type A

OTHER

Patients were treated with Botulinum toxin type A

Drug: Botulinum toxin type A

Interventions

Botulinum toxin type A DRUG

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

Patients treated with Botulinum toxin type A

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Juan Ye

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Blepharospasm

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Juan Ye

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

• Huina Zhang

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY DIRECTOR

• Qi Gao

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

• Jiajun Xie

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Ye

CONTACT

057187783897; yejuan@zju.edu.cn

Huina Zhang

CONTACT

0571-87783897; zhanghuina@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 25, 2021
• Study Start: July 12, 2021
• Primary Completion: December 24, 2021
• Study Completion: July 15, 2022
• Last Updated: July 19, 2022

Record last verified: 2021-07

Locations

CN (1)