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

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.

Study Overview

• Status: Recruiting
• Conditions: Blepharospasm
• Intervention / Treatment: Drug: Botulinum toxin type A

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Juan Ye; Phone Number: 057187783897; Email: yejuan@zju.edu.cn
• Study Contact Backup: Name: Huina Zhang; Phone Number: 0571-87783897; Email: zhanghuina@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Juan Ye
      • Contact: Juan Ye; Phone Number: +81-0571-87783897; Email: yejuan@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients treated with Botulinum toxin type A; Patients were treated with Botulinum toxin type A	Drug: Botulinum toxin type A; Patients were treated with Botulinum toxin type A applications on the Orbicularis oculi and glabellar complex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Chair: Juan Ye, Second Affiliated Hospital, School of Medicine, Zhejiang University; Study Director: Huina Zhang, Second Affiliated Hospital, School of Medicine, Zhejiang University; Principal Investigator: Qi Gao, Second Affiliated Hospital, School of Medicine, Zhejiang University; Principal Investigator: Jiajun Xie, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2021
• Primary Completion (Actual): December 24, 2021
• Study Completion (Anticipated): July 15, 2022

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 25, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Blepharospasm; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 2020-487

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No