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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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11 December 2017 |
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Main ID: |
ChiCTR-ONN-17013806 |
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Date of registration:
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2017-12-10 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Prospective study on the efficacy of botulinum toxin A injection and deep brain stimulation in the treatment of primary Meige syndrome
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Scientific title:
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Prospective study on the efficacy of botulinum toxin A injection and deep brain stimulation in the treatment of primary Meige syndrome |
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Date of first enrolment:
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2018-01-01 |
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Target sample size:
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treatment group:50;control group:50; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=23708 |
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Study type:
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Observational study |
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Study design:
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Non randomized control
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Phase:
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New Treatment Measure Clinical Study
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Countries of recruitment
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China
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Contacts
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Name:
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Fu Jing
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Address:
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1 Dong Jiao Min Xiang, Beijing, China
100730
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Telephone:
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+86 13801218591 |
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Email:
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fu_jing@126.com |
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Affiliation:
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Bei Jing Tong Ren hospital, Capital Medical University |
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Name:
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Fu Jing
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Address:
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1 Dong Jiao Min Xiang, Beijing, China
100730
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Telephone:
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+86 13801218591 |
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Email:
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fu_jing@126.com |
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Affiliation:
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Bei Jing Tong Ren hospital, Capital Medical University |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients diagnosed with primary Meige syndrome;
2. Patients who have failed to effectively control symptoms and seriously affect quality of life through botulinum A toxin treatment;
3. Good health conditions except the symptoms of dystonia;
4. The results of the simple mental state scale (MMSE) screening were normal;
5. The subjects or their families can fully understand the therapy and sign the informed consent;
6. The subjects have good compliance and can cooperate with the follow-up requirements after the operation.
Exclusion criteria: 1. Imaging examination of patients with abnormal changes in the basal ganglia;
2. Patients had a serious progressive nervous system, a cardiovascular system, a respiratory system, or a digestive system disease; the patient's mental state is unstable;
3. Patients have surgical or anesthetic contraindications, such as long-term anticoagulant, antiplatelet drugs, etc;
4. Women who are planning to be pregnant, or are in pregnancy and breast-feeding;
5. Patients had or needs other implants, such as the cardiac pacemaker, defibrillator, cochlear, and the root electric stimulator;
6. Patients need multiple 3.0T MRI tests during future clinical trials for their own reasons;
7. Patient had taken part in other clinical trials.
Age minimum:
35
Age maximum:
80
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Primary Meige syndrome
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Intervention(s)
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treatment group:Deep brain stimulation;control group:Botulinum toxin type A injection;
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Primary Outcome(s)
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Burke-Fahn-Marsden DystoniaRating Scale;
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Secondary Outcome(s)
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Adverse reaction and Quality of life scale;HAMA and HAMD Scale;
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Source(s) of Monetary Support
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13th Five-Year National Science and technology support program
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Ethics review
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Status: Not approved
Approval date: 26/08/2013
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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