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| Name | Class |
|---|---|
| Beijing Pins Medical Co., Ltd | INDUSTRY |
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Craniocervical dystonia, characterized by symptoms distributed in the craniofacial and/or cervical regions, is a type of focal or segmental dystonia and is the most common form of dystonia in adults. Deep brain stimulation (DBS) is a significant therapeutic approach for medically refractory craniocervical dystonia. The commonly utilized DBS targets are the Globus Pallidus internus (GPi) and the Subthalamic Nucleus (STN). Current research indicates no significant difference in efficacy between these two targets, although there are some differences in the onset time, stimulation voltage, and complications. Studies utilizing magnetic resonance imaging (MRI) to assess brain activity differences in patients with dystonia have found that patients exhibit increased activity and enhanced plasticity across a broad range of brain regions, including the brainstem, cortex, subcortical structures, and the basal ganglia, among others. Consequently, an increasing number of studies are classifying dystonia within the spectrum of brain network disorders. This study aims to recruit patients with craniocervical dystonia who meet the inclusion criteria, randomly assigning them into two groups of 30 patients each. One group will receive stimulation targeting the STN, and the other will target the GPi. Using functional MRI, researcher will conduct a dynamic brain network analysis to explore the differences in the brain network mechanisms underlying the treatment of craniocervical dystonia patients between the STN and GPi targets.
The objectives of this study are: 1) to explore the differences of brain network mechanisms between STN and GPi targets in craniocervical dystonia; 2. To explore the effects of DBS on dysarthsia and dysphagia in patients with craniocervical dystonia and the differences in efficacy, quality of life and side effects between GPi and STN targets in the treatment of craniocervical dystonia; 3. To explore the differences in the electrophysiological signals of nuclei collected during DBS surgery and their application in programming.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | GPi-DBS group |
|
| Group B | Experimental | STN-DBS group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| deep brain stimulation | Device | Group A was the GPi-DBS stimulation group; Group B was the STN-DBS stimulation group |
|
| Measure | Description | Time Frame |
|---|---|---|
| resting-state functional magnetic resonance imaging data | First, all participants underwent a standardized rs-fMRI scan for data collection of resting-state BOLD signals. Secondly, data preprocessing was carried out, including head movement correction, non-brain tissue removal, temporal layer correction, spatial normalization, filtering, and removal of physiological noise. Then, the brain network was constructed based on the pre-processed data and the structural features of the brain network were identified. Finally, statistical analysis was used to compare the differences in brain network characteristics between the two groups. | Change from baseline at 1, 6,12 months and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Burke-Fahn-Marsden Scale (BFMDRS) | This scale was used to evaluate the severity of dystonia in the subjects, with a total score of 120 points, with higher scores indicating greater symptom severity | Change from baseline at 1, 6,12 months and 24 months |
| Toronto West Spasmodic Torticollis Rating Scale Scale(TWSTRS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chaoshi Niu | Contact | 13855186208 | niuchaoshi@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Ustc | Recruiting | Hefei | Anhui | China |
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| ID | Term |
|---|---|
| D004421 | Dystonia |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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Device: Deep Brain Stimulation (DBS) of Gpi,PINS G106R Device: Deep Brain Stimulation (DBS) of STN,PINS G106R
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The total score ranges from 0 to 85, with higher scores indicating more severe disease symptoms |
| Change from baseline at 1, 6,12 months and 24 months |
| Craniocervical Dystonia Questionnaire | The questionnaire each entry into 0 (never) - 4 points (always), higher scores on behalf of the increasingly serious damage | Change from baseline at 1, 6,12 months and 24 months |
| Frenchay dysarthria scale | The scale is divided into 28, each fine items according to the severity was divided into a to e grade 5 | Change from baseline at 1, 6,12 months and 24 months |
| Watian Drinking Experiment | The Watian Drinking Experiment was used to evaluate the swallowing function of the subjects on a 5-point scale, and the normal level was 1 (swallow water within 5 seconds). Suspicious for level 1 (more than 5 seconds will swallow water) or level 2; Exception for 3 ~ 5 | Change from baseline at 1, 6,12 months and 24 months |
| Number of Deep Brain Stimulation programming | The number of times participants were programmed after DBS | Change from baseline at 1, 6,12 months and 24 months |
| Number of side effects in Deep Brain Stimulation programming | Change from baseline at 1, 6,12 months and 24 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |