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| Name | Class |
|---|---|
| Peking Union Medical College Hospital | OTHER |
| The First Affiliated Hospital of Dalian Medical University | OTHER |
| China-Japan Friendship Hospital | OTHER |
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Primary cranial-cervical dystonia is managed mainly by repeated botulinum toxin injections.This study is to establish whether subthalamic nucleus neurostimulation could improve symptoms in patients not adequately responding to chemodenervation or oral drug treatment. Investigators compared this surgical treatment with sham stimulation in a randomized, controlled clinical trial.
In this randomised, sham-controlled trial, investigators will recruit forty patients with primary cranial-cervical dystonia to receive an implanted device for STN-DBS, and participants will be randomly assigned to receive either neurostimulation or sham stimulation for 3 months.The primary end point was the change from baseline to 3 months in the severity of symptoms, according to the Burke-Fahn-Marsden Dystonia Rating Scale. Two masked dystonia experts who unaware of treatment status will assess the severity of dystonia by reviewing standardised videos.Subsequently, all patients will receive open-label neurostimulation; blinded assessment will be repeated after 6 months of active treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stimulation Group | Experimental | Patients in 'Neurostimulation Group' will receive subthalamic nucleus deep brain stimulation for 3 months. |
|
| Sham-stimulation Group | Sham Comparator | Patients in 'Sham-stimulation Group' will receive sham stimulation of subthalamic nucleus for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stimulation | Procedure | After surgery, patients in 'Neurostimulation Group' will receive subthalamic nucleus stimulation for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of motor and disability scores | Burke-Fahn-Marsden Dystonia Rating Scale (movement and disability scores, BFMDRSM/D) | Baseline,3 months after surgery, 6 months after active stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | SF-36 | Baseline,3 months after surgery,6 months after active stimulation |
| Depression | Beck Depression Inventory | Baseline,3 months after surgery,6 months after active stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event | 3 months after surgery,6 months after active stimulation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhang Kai, MD | Contact | 861067096767 | zhangkai62035@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhang Jian-guo, MD | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital Affiliated to Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100050 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18439222 | Result | Skogseid IM. Pallidal deep brain stimulation is effective, and improves quality of life in primary segmental and generalized dystonia. Acta Neurol Scand Suppl. 2008;188:51-5. doi: 10.1111/j.1600-0404.2008.01032.x. | |
| 21553081 | Result | Limotai N, Go C, Oyama G, Hwynn N, Zesiewicz T, Foote K, Bhidayasiri R, Malaty I, Zeilman P, Rodriguez R, Okun MS. Mixed results for GPi-DBS in the treatment of cranio-facial and cranio-cervical dystonia symptoms. J Neurol. 2011 Nov;258(11):2069-74. doi: 10.1007/s00415-011-6075-0. Epub 2011 May 7. |
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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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| Sham-stimulation | Procedure | After surgery, patients in 'sham-stimulation Group' will receive subthalamic nucleus sham-stimulation for 3 months. |
|
| Beijing Tiantan Hospital Affiliated to Capital Medical University | Recruiting | Beijing | 100050 | China |
|
| 21312284 | Result | Reese R, Gruber D, Schoenecker T, Bazner H, Blahak C, Capelle HH, Falk D, Herzog J, Pinsker MO, Schneider GH, Schrader C, Deuschl G, Mehdorn HM, Kupsch A, Volkmann J, Krauss JK. Long-term clinical outcome in meige syndrome treated with internal pallidum deep brain stimulation. Mov Disord. 2011 Mar;26(4):691-8. doi: 10.1002/mds.23549. Epub 2011 Feb 10. |
| 24440061 | Result | Ostrem JL, Markun LC, Glass GA, Racine CA, Volz MM, Heath SL, de Hemptinne C, Starr PA. Effect of frequency on subthalamic nucleus deep brain stimulation in primary dystonia. Parkinsonism Relat Disord. 2014 Apr;20(4):432-8. doi: 10.1016/j.parkreldis.2013.12.012. Epub 2014 Jan 5. |
| 23861342 | Result | Cao C, Pan Y, Li D, Zhan S, Zhang J, Sun B. Subthalamus deep brain stimulation for primary dystonia patients: a long-term follow-up study. Mov Disord. 2013 Nov;28(13):1877-82. doi: 10.1002/mds.25586. Epub 2013 Jul 16. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |