Clinical Trial of STN-DBS for Primary Cranial-Cervical Dystonia
NCT ID: NCT02583074
Last Updated: 2018-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2015-09-15
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Stimulation Group
Patients in 'Neurostimulation Group' will receive subthalamic nucleus deep brain stimulation for 3 months.
Stimulation
After surgery, patients in 'Neurostimulation Group' will receive subthalamic nucleus stimulation for 3 months.
Sham-stimulation Group
Patients in 'Sham-stimulation Group' will receive sham stimulation of subthalamic nucleus for 3 months.
Sham-stimulation
After surgery, patients in 'sham-stimulation Group' will receive subthalamic nucleus sham-stimulation for 3 months.
Interventions
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Stimulation
After surgery, patients in 'Neurostimulation Group' will receive subthalamic nucleus stimulation for 3 months.
Sham-stimulation
After surgery, patients in 'sham-stimulation Group' will receive subthalamic nucleus sham-stimulation for 3 months.
Eligibility Criteria
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Inclusion Criteria
2. Medical intractable：including various drugs and local botulinum toxin injections.
3. patients deteriorated in activities of daily living and showed social withdrawal during the course of their disease as they suffered from apparent hyperkinesia of facial muscles and functional blindness secondary to severe blepharospasm.
Exclusion Criteria
2. Secondary causes will be excluded by standard cranial magnetic resonance imaging (MRI) scans.
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
The First Affiliated Hospital of Dalian Medical University
OTHER
China-Japan Friendship Hospital
OTHER
Beijing Tiantan Hospital
OTHER
Responsible Party
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Kai Zhang
PhD，MD
Principal Investigators
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Zhang Jian-guo, MD
Role: PRINCIPAL_INVESTIGATOR
Beijing Tiantan Hospital
Locations
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Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Zhang Jianguo, MD
Role: primary
Zhang Jianguo, MD
Role: primary
References
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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.
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.
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.
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.
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.
Other Identifiers
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ZYLX201305
Identifier Type: -
Identifier Source: org_study_id
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