Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with Botulinum toxin type A | Other | Patients were treated with Botulinum toxin type A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Drug | Patients were treated with Botulinum toxin type A applications on the Orbicularis oculi and glabellar complex |
|
| 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. |
| 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 |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Ye | Contact | 057187783897 | yejuan@zju.edu.cn | |
| Huina Zhang | Contact | 0571-87783897 | zhanghuina@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Juan Ye | Second Affiliated Hospital, School of Medicine, Zhejiang University | Study Chair |
| Huina Zhang | Second Affiliated Hospital, School of Medicine, Zhejiang University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Juan Ye | Recruiting | Hangzhou | Zhejiang | 310000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001764 | Blepharospasm |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
| Qi Gao | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Jiajun Xie | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |