<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03017586</url>
  </required_header>
  <id_info>
    <org_study_id>PINS-023</org_study_id>
    <nct_id>NCT03017586</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of DBS in Patients With Primary Dystonia</brief_title>
  <official_title>Subthalamic Nucleus (STN) and Globus Pallidus Internus (GPi) Deep Brain Stimulation (DBS) in Patients With Primary Dystonia（RELAX Study）</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Pins Medical Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Pins Medical Co., Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and effectiveness of deep brain&#xD;
      stimulation (DBS) of the subthalamic nucleus (STN) and globus pallidus internus (GPi) for&#xD;
      primary dystonia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dystonia is an uncommon brain disorder in which there is abnormal muscle tone producing&#xD;
      twisting, writhing movements and abnormal postures. It is associated with abnormal electrical&#xD;
      activity in two groups of nerve cells in the brain called the globus pallidus internus (GPi)&#xD;
      and the subthalamic nucleus (STN). GPi DBS appears to be effective for medication-refractory&#xD;
      focal and segmental dystonia affecting the cranial and cervical regions in open-label series,&#xD;
      but recently GPi stimulation has been associated with subtle motor disturbances in previously&#xD;
      non-dystonic body regions (i.e., arms and legs) in this population of patients. DBS of the&#xD;
      STN has also been reported to be effective for treating generalized and cervical dystonia in&#xD;
      small open label trials. STN DBS for cranial and cervical regions may provide similar&#xD;
      efficacy in the treatment of dystonia as GPi DBS, but without unwanted stimulation-induced&#xD;
      motor effects. Objectives of this study is to evaluate the safety and efficacy of STN-DBS and&#xD;
      GPi-DBS for dystonia; Participants will be evaluated pre- and postoperatively with standard&#xD;
      dystonia rating scales including the Burke-Fahn-Marsden Dystonia rating scale (BFMDRS),&#xD;
      Changes in cognitive function will be assessed with neuropsychological testing. Stimulation&#xD;
      parameters will be documented, and a patient questionnaire will be administered&#xD;
      postoperatively to determine if patients are experiencing stimulation-induced motor adverse&#xD;
      effects. Patient weight will be recorded at study visits. This pilot study will provide&#xD;
      preliminary open label efficacy outcomes for STN DBS in the treatment of primary dystonia and&#xD;
      will help determine if this target should be compared to GPi DBS in a larger double-blind&#xD;
      trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 27, 2017</start_date>
  <completion_date type="Actual">December 17, 2021</completion_date>
  <primary_completion_date type="Actual">September 13, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) movement score</measure>
    <time_frame>3，6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Short-Form General Health Survey (SF-36)</measure>
    <time_frame>3，6 monthsthe Beck Anxiety Inventory31 (with scores ranging from 0 to 63 and higher scores indicating more severe anxiety)</time_frame>
    <description>Quality of life was assessed with the Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36), which evaluates both physical and mental components of functioning on a scale of 0 to 100, with higher scores indicating a higher level of function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual analogue scale</measure>
    <time_frame>3，6 months</time_frame>
    <description>The severity of dystonia and pain was assessed with the use of a visual analogue scale, with scores ranging from 0 to 10 and higher scores indicating greater severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurements of walking</measure>
    <time_frame>3，6 months</time_frame>
    <description>Measurements of walking (the duration and number of steps taken in a 14-m walk with one turn)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Beck Depression Inventory</measure>
    <time_frame>3，6 months</time_frame>
    <description>The Beck Depression Inventory (with scores ranging from 0 to 63 and higher scores indicating more severe depression)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mini-Mental State Examination</measure>
    <time_frame>3，6 months</time_frame>
    <description>Cognitive were assessed by mini-mental state examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of improvement of BFMDRS score</measure>
    <time_frame>3，6 months</time_frame>
    <description>The rate of improvement of BFMDRS score that &gt;25%、&gt;50%、&gt;75%</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Dystonia</condition>
  <arm_group>
    <arm_group_label>STN</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DBS target with Subthalamic Nucleus (STN).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GPi</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DBS target with Globus Pallidus Internus (GPi).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Beijing Pins Medical Co., Ltd. Deep Brain Stimulator</intervention_name>
    <description>Deep Brain Stimulation for primary dystonia subjects</description>
    <arm_group_label>GPi</arm_group_label>
    <arm_group_label>STN</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Refractory primary (systemic, segmental) dystonia diagnosed by a movement disorders&#xD;
             neurologist&#xD;
&#xD;
          2. Severe functional impairment despite optimal medical management, including failed&#xD;
             botulinum toxin therapy&#xD;
&#xD;
          3. Ability to follow up with post-operative study visits&#xD;
&#xD;
          4. Patients and their relatives have reasonable surgery expectations&#xD;
&#xD;
          5. Volunteer to participate in clinical trials, and signed consent form&#xD;
&#xD;
          6. Age 6-60 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy or plan a pregnancy&#xD;
&#xD;
          2. Good treatment with Non-invasive therapy&#xD;
&#xD;
          3. Dopamine reactive dystonia ，Genetic degeneration ，Paroxysmal dystonia ，Secondary&#xD;
             dystonia， Psychogenic dystonia&#xD;
&#xD;
          4. Brain MRI showing extensive brain atrophy or small vessel ischemic disease&#xD;
&#xD;
          5. Cognitive impairment(MMSE&lt;24)&#xD;
&#xD;
          6. Severe depression or other serious mental illness&#xD;
&#xD;
          7. History of traumatic brain injury, tumor, or severe cerebrovascular disease&#xD;
&#xD;
          8. Severe brain atrophy (diagnosed by CT or MRI)&#xD;
&#xD;
          9. Hyperthermia therapy in implant parts&#xD;
&#xD;
         10. Abnormal in blood inspection, blood clotting disorders, liver and kidney dysfunction,&#xD;
             or other clinical judgment cannot tolerate surgery&#xD;
&#xD;
         11. High blood pressure, serious heart diseases, or respiratory diseases&#xD;
&#xD;
         12. Diabetes&#xD;
&#xD;
         13. Long-term treatment of immunosuppressive or hormones&#xD;
&#xD;
         14. Implant pacemakers, defibrillators, cochlear and other nerve stimulators&#xD;
&#xD;
         15. Other diseases need frequent MRI examinations&#xD;
&#xD;
         16. Participated in any other clinical trials within 3 months&#xD;
&#xD;
         17. Reluctant or unable to implant surgery&#xD;
&#xD;
         18. Reluctant or unable to cooperate with follow-up&#xD;
&#xD;
         19. Other exclusion Criteria by researchers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beijing Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Union Hospital Tongji Medical College Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanjing Brain Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qilu Hospital of Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tongji Hospital of Tongji Univeristy</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Run Run Shaw Hospital,School of Medicine,Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Benabid AL, Pollak P, Louveau A, Henry S, de Rougemont J. Combined (thalamotomy and stimulation) stereotactic surgery of the VIM thalamic nucleus for bilateral Parkinson disease. Appl Neurophysiol. 1987;50(1-6):344-6. doi: 10.1159/000100803.</citation>
    <PMID>3329873</PMID>
  </reference>
  <reference>
    <citation>Deep-Brain Stimulation for Parkinson's Disease Study Group; Obeso JA, Olanow CW, Rodriguez-Oroz MC, Krack P, Kumar R, Lang AE. Deep-brain stimulation of the subthalamic nucleus or the pars interna of the globus pallidus in Parkinson's disease. N Engl J Med. 2001 Sep 27;345(13):956-63. doi: 10.1056/NEJMoa000827.</citation>
    <PMID>11575287</PMID>
  </reference>
  <reference>
    <citation>Krack P, Pollak P, Limousin P, Hoffmann D, Xie J, Benazzouz A, Benabid AL. Subthalamic nucleus or internal pallidal stimulation in young onset Parkinson's disease. Brain. 1998 Mar;121 ( Pt 3):451-7. doi: 10.1093/brain/121.3.451.</citation>
    <PMID>9549521</PMID>
  </reference>
  <reference>
    <citation>Herzog J, Volkmann J, Krack P, Kopper F, Potter M, Lorenz D, Steinbach M, Klebe S, Hamel W, Schrader B, Weinert D, Muller D, Mehdorn HM, Deuschl G. Two-year follow-up of subthalamic deep brain stimulation in Parkinson's disease. Mov Disord. 2003 Nov;18(11):1332-7. doi: 10.1002/mds.10518.</citation>
    <PMID>14639676</PMID>
  </reference>
  <reference>
    <citation>Beric A, Kelly PJ, Rezai A, Sterio D, Mogilner A, Zonenshayn M, Kopell B. Complications of deep brain stimulation surgery. Stereotact Funct Neurosurg. 2001;77(1-4):73-8. doi: 10.1159/000064600.</citation>
    <PMID>12378060</PMID>
  </reference>
  <reference>
    <citation>Oh MY, Abosch A, Kim SH, Lang AE, Lozano AM. Long-term hardware-related complications of deep brain stimulation. Neurosurgery. 2002 Jun;50(6):1268-74; discussion 1274-6. doi: 10.1097/00006123-200206000-00017.</citation>
    <PMID>12015845</PMID>
  </reference>
  <reference>
    <citation>Umemura A, Jaggi JL, Hurtig HI, Siderowf AD, Colcher A, Stern MB, Baltuch GH. Deep brain stimulation for movement disorders: morbidity and mortality in 109 patients. J Neurosurg. 2003 Apr;98(4):779-84. doi: 10.3171/jns.2003.98.4.0779.</citation>
    <PMID>12691402</PMID>
  </reference>
  <reference>
    <citation>Benazzouz A, Piallat B, Pollak P, Benabid AL. Responses of substantia nigra pars reticulata and globus pallidus complex to high frequency stimulation of the subthalamic nucleus in rats: electrophysiological data. Neurosci Lett. 1995 Apr 14;189(2):77-80. doi: 10.1016/0304-3940(95)11455-6.</citation>
    <PMID>7609923</PMID>
  </reference>
  <reference>
    <citation>Benazzouz A, Gao DM, Ni ZG, Piallat B, Bouali-Benazzouz R, Benabid AL. Effect of high-frequency stimulation of the subthalamic nucleus on the neuronal activities of the substantia nigra pars reticulata and ventrolateral nucleus of the thalamus in the rat. Neuroscience. 2000;99(2):289-95. doi: 10.1016/s0306-4522(00)00199-8.</citation>
    <PMID>10938434</PMID>
  </reference>
  <reference>
    <citation>Dostrovsky JO, Levy R, Wu JP, Hutchison WD, Tasker RR, Lozano AM. Microstimulation-induced inhibition of neuronal firing in human globus pallidus. J Neurophysiol. 2000 Jul;84(1):570-4. doi: 10.1152/jn.2000.84.1.570.</citation>
    <PMID>10899228</PMID>
  </reference>
  <reference>
    <citation>Filali M, Hutchison WD, Palter VN, Lozano AM, Dostrovsky JO. Stimulation-induced inhibition of neuronal firing in human subthalamic nucleus. Exp Brain Res. 2004 Jun;156(3):274-81. doi: 10.1007/s00221-003-1784-y. Epub 2004 Jan 24.</citation>
    <PMID>14745464</PMID>
  </reference>
  <reference>
    <citation>Tai CH, Boraud T, Bezard E, Bioulac B, Gross C, Benazzouz A. Electrophysiological and metabolic evidence that high-frequency stimulation of the subthalamic nucleus bridles neuronal activity in the subthalamic nucleus and the substantia nigra reticulata. FASEB J. 2003 Oct;17(13):1820-30. doi: 10.1096/fj.03-0163com.</citation>
    <PMID>14519661</PMID>
  </reference>
  <reference>
    <citation>Hashimoto T, Elder CM, Okun MS, Patrick SK, Vitek JL. Stimulation of the subthalamic nucleus changes the firing pattern of pallidal neurons. J Neurosci. 2003 Mar 1;23(5):1916-23. doi: 10.1523/JNEUROSCI.23-05-01916.2003.</citation>
    <PMID>12629196</PMID>
  </reference>
  <reference>
    <citation>McIntyre CC, Grill WM, Sherman DL, Thakor NV. Cellular effects of deep brain stimulation: model-based analysis of activation and inhibition. J Neurophysiol. 2004 Apr;91(4):1457-69. doi: 10.1152/jn.00989.2003. Epub 2003 Dec 10.</citation>
    <PMID>14668299</PMID>
  </reference>
  <reference>
    <citation>Kupsch A, Benecke R, Muller J, Trottenberg T, Schneider GH, Poewe W, Eisner W, Wolters A, Muller JU, Deuschl G, Pinsker MO, Skogseid IM, Roeste GK, Vollmer-Haase J, Brentrup A, Krause M, Tronnier V, Schnitzler A, Voges J, Nikkhah G, Vesper J, Naumann M, Volkmann J; Deep-Brain Stimulation for Dystonia Study Group. Pallidal deep-brain stimulation in primary generalized or segmental dystonia. N Engl J Med. 2006 Nov 9;355(19):1978-90. doi: 10.1056/NEJMoa063618.</citation>
    <PMID>17093249</PMID>
  </reference>
  <reference>
    <citation>Vidailhet M, Vercueil L, Houeto JL, Krystkowiak P, Benabid AL, Cornu P, Lagrange C, Tezenas du Montcel S, Dormont D, Grand S, Blond S, Detante O, Pillon B, Ardouin C, Agid Y, Destee A, Pollak P; French Stimulation du Pallidum Interne dans la Dystonie (SPIDY) Study Group. Bilateral deep-brain stimulation of the globus pallidus in primary generalized dystonia. N Engl J Med. 2005 Feb 3;352(5):459-67. doi: 10.1056/NEJMoa042187.</citation>
    <PMID>15689584</PMID>
  </reference>
  <reference>
    <citation>Volkmann J, Wolters A, Kupsch A, Muller J, Kuhn AA, Schneider GH, Poewe W, Hering S, Eisner W, Muller JU, Deuschl G, Pinsker MO, Skogseid IM, Roeste GK, Krause M, Tronnier V, Schnitzler A, Voges J, Nikkhah G, Vesper J, Classen J, Naumann M, Benecke R; DBS study group for dystonia. Pallidal deep brain stimulation in patients with primary generalised or segmental dystonia: 5-year follow-up of a randomised trial. Lancet Neurol. 2012 Dec;11(12):1029-38. doi: 10.1016/S1474-4422(12)70257-0. Epub 2012 Nov 1.</citation>
    <PMID>23123071</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23861342</PMID>
  </reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>July 12, 2023</last_update_submitted>
  <last_update_submitted_qc>July 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dystonia</mesh_term>
    <mesh_term>Dystonic Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data is available upon request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>De-identified data may be available after results have been published</ipd_time_frame>
    <ipd_access_criteria>Individual participant data is available upon request.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 26, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/86/NCT03017586/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03017586
org study id: PINS-023
nct id: NCT03017586
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the safety and effectiveness of deep brain
      stimulation (DBS) of the subthalamic nucleus (STN) and globus pallidus internus (GPi) for
      primary dystonia.
Dystonia is an uncommon brain disorder in which there is abnormal muscle tone producing
      twisting, writhing movements and abnormal postures. It is associated with abnormal electrical
      activity in two groups of nerve cells in the brain called the globus pallidus internus (GPi)
      and the subthalamic nucleus (STN). GPi DBS appears to be effective for medication-refractory
      focal and segmental dystonia affecting the cranial and cervical regions in open-label series,
      but recently GPi stimulation has been associated with subtle motor disturbances in previously
      non-dystonic body regions (i.e., arms and legs) in this population of patients. DBS of the
      STN has also been reported to be effective for treating generalized and cervical dystonia in
      small open label trials. STN DBS for cranial and cervical regions may provide similar
      efficacy in the treatment of dystonia as GPi DBS, but without unwanted stimulation-induced
      motor effects. Objectives of this study is to evaluate the safety and efficacy of STN-DBS and
      GPi-DBS for dystonia; Participants will be evaluated pre- and postoperatively with standard
      dystonia rating scales including the Burke-Fahn-Marsden Dystonia rating scale (BFMDRS),
      Changes in cognitive function will be assessed with neuropsychological testing. Stimulation
      parameters will be documented, and a patient questionnaire will be administered
      postoperatively to determine if patients are experiencing stimulation-induced motor adverse
      effects. Patient weight will be recorded at study visits. This pilot study will provide
      preliminary open label efficacy outcomes for STN DBS in the treatment of primary dystonia and
      will help determine if this target should be compared to GPi DBS in a larger double-blind
      trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: change in Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) movement score
time frame: 3，6 months
measure: Short-Form General Health Survey (SF-36)
time frame: 3，6 monthsthe Beck Anxiety Inventory31 (with scores ranging from 0 to 63 and higher scores indicating more severe anxiety)
description: Quality of life was assessed with the Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36), which evaluates both physical and mental components of functioning on a scale of 0 to 100, with higher scores indicating a higher level of function.
measure: Visual analogue scale
time frame: 3，6 months
description: The severity of dystonia and pain was assessed with the use of a visual analogue scale, with scores ranging from 0 to 10 and higher scores indicating greater severity
measure: Measurements of walking
time frame: 3，6 months
description: Measurements of walking (the duration and number of steps taken in a 14-m walk with one turn)
measure: The Beck Depression Inventory
time frame: 3，6 months
description: The Beck Depression Inventory (with scores ranging from 0 to 63 and higher scores indicating more severe depression)
measure: Mini-Mental State Examination
time frame: 3，6 months
description: Cognitive were assessed by mini-mental state examination
measure: The rate of improvement of BFMDRS score
time frame: 3，6 months
description: The rate of improvement of BFMDRS score that >25%、>50%、>75%
arm group label: STN
arm group type: Experimental
description: DBS target with Subthalamic Nucleus (STN).
arm group label: GPi
arm group type: Experimental
description: DBS target with Globus Pallidus Internus (GPi).
intervention type: Device
intervention name: Beijing Pins Medical Co., Ltd. Deep Brain Stimulator
description: Deep Brain Stimulation for primary dystonia subjects
arm group label: GPi
arm group label: STN
criteria: 
gender: All
minimum age: 6 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
citation: Benabid AL, Pollak P, Louveau A, Henry S, de Rougemont J. Combined (thalamotomy and stimulation) stereotactic surgery of the VIM thalamic nucleus for bilateral Parkinson disease. Appl Neurophysiol. 1987;50(1-6):344-6. doi: 10.1159/000100803.
PMID: 3329873
citation: Deep-Brain Stimulation for Parkinson's Disease Study Group; Obeso JA, Olanow CW, Rodriguez-Oroz MC, Krack P, Kumar R, Lang AE. Deep-brain stimulation of the subthalamic nucleus or the pars interna of the globus pallidus in Parkinson's disease. N Engl J Med. 2001 Sep 27;345(13):956-63. doi: 10.1056/NEJMoa000827.
PMID: 11575287
citation: Krack P, Pollak P, Limousin P, Hoffmann D, Xie J, Benazzouz A, Benabid AL. Subthalamic nucleus or internal pallidal stimulation in young onset Parkinson's disease. Brain. 1998 Mar;121 ( Pt 3):451-7. doi: 10.1093/brain/121.3.451.
PMID: 9549521
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responsible party type: Sponsor
mesh term: Dystonia
mesh term: Dystonic Disorders
sharing ipd: Yes
ipd description: Individual participant data is available upon request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: De-identified data may be available after results have been published
ipd access criteria: Individual participant data is available upon request.
provided document: 