Deep Brain Stimulation of subthalamic nucleus to treat Meige Syndrome: registry study

• Register: ChiCTR
• Last refreshed on: 19 June 2017
• Main ID: ChiCTR-OOC-17011684
• Date of registration: 2017-06-17
• Prospective Registration: Yes
• Primary sponsor: Aviation General Hospital of China Medical University
• Public title: Deep Brain Stimulation of subthalamic nucleus to treat Meige Syndrome: registry study
• Scientific title: Deep Brain Stimulation of subthalamic nucleus to treat Meige Syndrome: registry study
• Date of first enrolment: 2017-06-17
• Target sample size: Case series:10;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=19379
• Study type: Observational study
• Study design: Case series
• Phase: Other

Countries of recruitment

China

Contacts

• Name: Lin Wang
• Affiliation: Aviation General Hospital of China Medical University

• Name: Chen Yao
• Affiliation: Department of Neurosurgery, Zhujiang Hospital, Southern Medical University

Key inclusion & exclusion criteria

Inclusion criteria: 1. The diagnosis of idiopathic cranial facial focal or segmental dystonia, including simple blepharospasm or oromandibular dystonia patients, as well as other parts of the muscle of any of the above symptoms involving the craniofacial;
2. Patients who have failed to effectively control symptoms and / or have been treated with oral botulinum toxin for at least 6 months, and who have severe impact on their quality of life, are required to undergo surgical treatment;
3. Except for symptoms of dystonia, the body is in good health;
4. The MMSE showed normal screening results;
5. The subjects or their families can fully understand the treatment and sign informed consent;
6. The subjects with good compliance, can be required to complete the follow-up after operation.
Exclusion criteria: 1. Imaging findings of patients with abnormal basal ganglia;
2. Patients suffer from severe progressive neurological, cardiovascular, respiratory, or digestive diseases;
3. The patient's mental state is unstable;
4. Patients with contraindications to surgery or anesthesia, such as long-term use of anticoagulant, antiplatelet drugs;
5. Female patients who are planning to conceive or are pregnant and lactating women.
6. The patients have or need other implantable devices, such as pacemakers, defibrillators, cochlear and spinal nerve stimulator;
7. The patients need do repeated MRI because of their own reasons during clinical trials in the future;
8. The patients have participated in other clinical trials.

Age minimum: 18
Age maximum: 80
Gender: Both

Health Condition(s) or Problem(s) studied

Meige syndrome

Intervention(s)

Case series:STN DBS;

Primary Outcome(s)

BFMDRS scale;

Secondary Outcome(s)

SF-36 scale;Score of HAMD;Score of YALE-BROWN;Cognitive Tests;

Source(s) of Monetary Support

Self funding