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Deep-brain stimulation (DBS) is an effective treatment for patients with Meige syndrome. The globus pallidus interna (GPi) and the subthalamic nucleus (STN) are both accepted targets for this treatment. Researchers designed this study to compare the 12-month outcomes for patients who undergo bilateral stimulation of the GPi or STN.
Deep-brain stimulation (DBS) is an effective treatment for patients with Meige syndrome. The globus pallidus interna (GPi) and the subthalamic nucleus (STN) are accepted targets for this treatment. Researchers are willing to compared12-month outcomes for patients who had undergone bilateral stimulation of the GPi or STN. Forty-two Asian patients with primary Meige syndrome who underwent GPi or STN neurostimulation were recruited between Nov. 2023 and Nov. 2025 at the Department of Neurosurgery, Qilu Hospital. The primary outcome was the change in motor function, including the Burke-Fahn-Marsden Dystonia Rating Scale movement (BFMDRS-M) and disability subscale (BFMDRS-D) at 3 days before DBS (baseline) surgery and 1, 3, 6, and 12 months after surgery. Secondary outcomes included health-related quality of life, sleep quality status, depression severity, and anxiety severity at 3 days before and 12 months after DBS surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilateral STN deep brain stimulation | Placebo Comparator | Patients with Meige syndrome accepted STN DBS |
|
| Bilateral GPi deep brain stimulation | Experimental | Patients with Meige syndrome accepted GPi DBS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral STN deep brain stimulation | Device | patients with Meige syndrome underwent bilateral subthalamic stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in motor function | The primary outcome was the change in motor function, including the Burke-Fahn-Marsden Dystonia Rating Scale movement (BFMDRS-M)at 3 days before DBS (baseline) surgery and 1, 3, 6, and 12 months after surgery. | 12 months after DBS |
| Measure | Description | Time Frame |
|---|---|---|
| health-related quality of life | Secondary outcomes included health-related quality of life (EuroQol Five Dimensions Questionnaire) at 3 days before and 12 months after DBS surgery. | 12 months after DBS |
| sleep quality status |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| chao zhang | Contact | 053182166631 | chao_zhang@sdu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chao Zhang | Recruiting | Jinan | Shandong | 250100 | China |
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| ID | Term |
|---|---|
| D008538 | Meige Syndrome |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Bilateral GPi deep brain stimulation | Device | patients with Meige syndrome underwent bilateral pallidal stimulation |
|
Secondary outcomes included sleep quality status (Pittsburgh Sleep Quality Index) at 3 days before and 12 months after DBS surgery.
| 12 months after DBS |
| Mental syndrome | Secondary outcomes included depression severity, and anxiety severity including Hamilton Depression Scale (HAMD) scores at 3 days before and 12 months after DBS surgery. | 12 months after DBS |
| Mental syndrome | Secondary outcomes included depression severity, and anxiety severity including Hamilton Anxiety Scale (HAMA) scores at 3 days before and 12 months after DBS surgery. | 12 months after DBS |
| D020821 | Dystonic Disorders |
| D009069 | Movement Disorders |