<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/NCT04449068</url>
  </required_header>
  <id_info>
    <org_study_id>APHP190808</org_study_id>
    <nct_id>NCT04449068</nct_id>
  </id_info>
  <brief_title>Observational Database on Deep Brain Stimulation in Tourette Syndrome</brief_title>
  <acronym>POSTSTIC</acronym>
  <official_title>Pre et Post-operative Evaluation of Patients With Tourette Syndrome Treated With High Frequency Bilateral Stimulation of the Anterior Part of the Internal Pallid Globus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</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>
      Within an ongoing deep brain stimulation (DBS) program for Tourette syndrome (TS) at the&#xD;
      Department of Neurology, Pitié-Salpêtrière Hospital, Paris/France, the investigator team&#xD;
      plans to evaluate patients pre-operatively and then at one year intervals post-operatively&#xD;
      until the 5-year mark has been achieved. The investigator team will investigate tic severity,&#xD;
      psychiatric co-morbidities, quality of life, and neuropsychological measures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Since the completion of the STIC trial in 2017, the french team continues to offer DBS of the&#xD;
      globus pallidus internus (GPi) to selected, treatment-refractory patients with TS. On&#xD;
      average, three to four patients undergo surgery every year. Even though a first follow-up of&#xD;
      the STIC cohort up to four years post-op indicates ongoing improvement of tic severity, many&#xD;
      questions remains regarding the efficacy of GPi DBS in TS. These questions include frequent&#xD;
      comorbidities of TS, quality of life, evolution of medication and stimulation parameters, as&#xD;
      well as neuropsychological functioning. Therefore, the investigator proposes to evaluate all&#xD;
      patients undergoing GPi DBS for TS to be evaluated comprehensively pre-operatively and once&#xD;
      yearly after surgery until reaching the 5-year mark. The investigator team hopes these data&#xD;
      may help to plan for future international multicenter trials, and provide indications on&#xD;
      prognostic factors concerning response to GPi DBS in TS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">July 15, 2020</start_date>
  <completion_date type="Anticipated">July 15, 2030</completion_date>
  <primary_completion_date type="Anticipated">July 15, 2030</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measure the severity of tics</measure>
    <time_frame>Month 60</time_frame>
    <description>Measure the severity of tics, determined by the YGTSS-R (Yale Global Tic Severity Scale score - revised) .&#xD;
The overall score is between 0 (no TICS) and 100 (severity in TICS) therefore a score decrease is expected .</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Tourette Syndrome</condition>
  <arm_group>
    <arm_group_label>Evaluation of patients with Tourette's Gilles Syndrome</arm_group_label>
    <description>Neurological and neuropsychological evaluations of patients with Tourette's Gilles syndrome treated with high frequency bilateral stimulation of the anterior part of the internal pallid globus</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neurological and neuropsychological Follow-up after deep brain stimulation</intervention_name>
    <description>Investigation of tic severity, psychiatric co-morbidities, quality of life, and neuropsychologcial measures until the 5-year after deep brain stimulation (DBS)</description>
    <arm_group_label>Evaluation of patients with Tourette's Gilles Syndrome</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with Tourette syndrome eligible for bilateral deep brain stimulation of the&#xD;
        anterior internal pallid globus&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Tourette syndrome severe and drug-resistant eligible for bilateral deep brain&#xD;
             stimulation&#xD;
&#xD;
          -  Person who voluntarily and knowledgeably agreed to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non affiliation to a French social security system (recipient or assign) excluding AME&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Andreas HARTMANN, MD</last_name>
    <phone>1 42 16 13 16</phone>
    <phone_ext>+33</phone_ext>
    <email>andreas.hartmann@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yulia Worbe, MD,PHD</last_name>
    <phone>142161316</phone>
    <phone_ext>+33</phone_ext>
    <email>yulia.worbe@aphp.fr</email>
  </overall_contact_backup>
  <reference>
    <citation>Welter ML, Houeto JL, Thobois S, Bataille B, Guenot M, Worbe Y, Hartmann A, Czernecki V, Bardinet E, Yelnik J, du Montcel ST, Agid Y, Vidailhet M, Cornu P, Tanguy A, Ansquer S, Jaafari N, Poulet E, Serra G, Burbaud P, Cuny E, Aouizerate B, Pollak P, Chabardes S, Polosan M, Borg M, Fontaine D, Giordana B, Raoul S, Rouaud T, Sauvaget A, Jalenques I, Karachi C, Mallet L; STIC study group. Anterior pallidal deep brain stimulation for Tourette's syndrome: a randomised, double-blind, controlled trial. Lancet Neurol. 2017 Aug;16(8):610-619. doi: 10.1016/S1474-4422(17)30160-6. Epub 2017 Jun 20.</citation>
    <PMID>28645853</PMID>
  </reference>
  <reference>
    <citation>Welter ML, Houeto JL, Worbe Y, Diallo MH, Hartmann A, Tezenas du Montcel S, Ansquer S, Thobois S, Fontaine D, Rouaud T, Cuny E, Karachi C, Mallet L; STIC study group. Long-term effects of anterior pallidal deep brain stimulation for tourette's syndrome. Mov Disord. 2019 Apr;34(4):586-588. doi: 10.1002/mds.27645. Epub 2019 Feb 20. No abstract available.</citation>
    <PMID>30788865</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bilateral deep brain stimulation</keyword>
  <keyword>Tourette syndrome,</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tourette Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- 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/NCT04449068
org study id: APHP190808
nct id: NCT04449068
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Within an ongoing deep brain stimulation (DBS) program for Tourette syndrome (TS) at the
      Department of Neurology, Pitié-Salpêtrière Hospital, Paris/France, the investigator team
      plans to evaluate patients pre-operatively and then at one year intervals post-operatively
      until the 5-year mark has been achieved. The investigator team will investigate tic severity,
      psychiatric co-morbidities, quality of life, and neuropsychological measures.
Since the completion of the STIC trial in 2017, the french team continues to offer DBS of the
      globus pallidus internus (GPi) to selected, treatment-refractory patients with TS. On
      average, three to four patients undergo surgery every year. Even though a first follow-up of
      the STIC cohort up to four years post-op indicates ongoing improvement of tic severity, many
      questions remains regarding the efficacy of GPi DBS in TS. These questions include frequent
      comorbidities of TS, quality of life, evolution of medication and stimulation parameters, as
      well as neuropsychological functioning. Therefore, the investigator proposes to evaluate all
      patients undergoing GPi DBS for TS to be evaluated comprehensively pre-operatively and once
      yearly after surgery until reaching the 5-year mark. The investigator team hopes these data
      may help to plan for future international multicenter trials, and provide indications on
      prognostic factors concerning response to GPi DBS in TS.
observational model: Cohort
time perspective: Prospective
measure: Measure the severity of tics
time frame: Month 60
description: Measure the severity of tics, determined by the YGTSS-R (Yale Global Tic Severity Scale score - revised) .
The overall score is between 0 (no TICS) and 100 (severity in TICS) therefore a score decrease is expected .
arm group label: Evaluation of patients with Tourette's Gilles Syndrome
description: Neurological and neuropsychological evaluations of patients with Tourette's Gilles syndrome treated with high frequency bilateral stimulation of the anterior part of the internal pallid globus
intervention type: Other
intervention name: Neurological and neuropsychological Follow-up after deep brain stimulation
description: Investigation of tic severity, psychiatric co-morbidities, quality of life, and neuropsychologcial measures until the 5-year after deep brain stimulation (DBS)
arm group label: Evaluation of patients with Tourette's Gilles Syndrome
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
last name: Andreas HARTMANN, MD
phone: 1 42 16 13 16
phone ext: +33
email: andreas.hartmann@aphp.fr
last name: Yulia Worbe, MD,PHD
phone: 142161316
phone ext: +33
email: yulia.worbe@aphp.fr
citation: Welter ML, Houeto JL, Thobois S, Bataille B, Guenot M, Worbe Y, Hartmann A, Czernecki V, Bardinet E, Yelnik J, du Montcel ST, Agid Y, Vidailhet M, Cornu P, Tanguy A, Ansquer S, Jaafari N, Poulet E, Serra G, Burbaud P, Cuny E, Aouizerate B, Pollak P, Chabardes S, Polosan M, Borg M, Fontaine D, Giordana B, Raoul S, Rouaud T, Sauvaget A, Jalenques I, Karachi C, Mallet L; STIC study group. Anterior pallidal deep brain stimulation for Tourette's syndrome: a randomised, double-blind, controlled trial. Lancet Neurol. 2017 Aug;16(8):610-619. doi: 10.1016/S1474-4422(17)30160-6. Epub 2017 Jun 20.
PMID: 28645853
citation: Welter ML, Houeto JL, Worbe Y, Diallo MH, Hartmann A, Tezenas du Montcel S, Ansquer S, Thobois S, Fontaine D, Rouaud T, Cuny E, Karachi C, Mallet L; STIC study group. Long-term effects of anterior pallidal deep brain stimulation for tourette's syndrome. Mov Disord. 2019 Apr;34(4):586-588. doi: 10.1002/mds.27645. Epub 2019 Feb 20. No abstract available.
PMID: 30788865
responsible party type: Sponsor
mesh term: Tourette Syndrome
mesh term: Syndrome