Botulinum Toxin Relieves Anxiety, Depression and Sleep Disorderes in Patients With Blepharospasm
Primary Purpose
Blepharospasm
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Botulinum toxin type A
Sponsored by
About this trial
This is an interventional treatment trial for Blepharospasm
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
Sites / Locations
- Juan YeRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients treated with Botulinum toxin type A
Arm Description
Patients were treated with Botulinum toxin type A
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04939909
First Posted
June 1, 2021
Last Updated
July 18, 2022
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04939909
Brief Title
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
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 12, 2021 (Actual)
Primary Completion Date
December 24, 2021 (Actual)
Study Completion Date
July 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharospasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients treated with Botulinum toxin type A
Arm Type
Other
Arm Description
Patients were treated with Botulinum toxin type A
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin type A
Intervention Description
Patients were treated with Botulinum toxin type A applications on the Orbicularis oculi and glabellar complex
Primary Outcome Measure Information:
Title
Change from baseline blepharospasm evaluation at 3 months
Description
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.
Time Frame
Through study completion, 3 months.
Secondary Outcome Measure Information:
Title
Change from baseline depression evaluation at 3 months
Description
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.
Time Frame
Through study completion, 3 months.
Title
Change from baseline anxiety evaluation at 3 months
Description
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.
Time Frame
Through study completion, 3 months.
Other Pre-specified Outcome Measures:
Title
Change from baseline sleep disorders evaluation at 3 months
Description
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).
Time Frame
Through study completion, 3 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Ye
Phone
057187783897
Email
yejuan@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Huina Zhang
Phone
0571-87783897
Email
zhanghuina@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Ye
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Huina Zhang
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Qi Gao
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jiajun Xie
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Juan Ye
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Ye
Phone
+81-0571-87783897
Email
yejuan@zju.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Botulinum Toxin Relieves Anxiety, Depression and Sleep Disorderes in Patients With Blepharospasm
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