<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/NCT01705418</url>
  </required_header>
  <id_info>
    <org_study_id>12PHR02</org_study_id>
    <nct_id>NCT01705418</nct_id>
  </id_info>
  <brief_title>Behavior Addictions Improvement in Parkinson Disease's Patients Treated by Subthalamic Stimulation : Long Term Follow-up</brief_title>
  <acronym>PDdicted</acronym>
  <official_title>Behavior Addictions Improvement in Parkinson Disease's Patients Treated by</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Improvement of behavioral addictions in STN-DBS in PD: Long term follow-up&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Whereas subthalamic nucleus (STN) stimulation is considered an established treatment for&#xD;
      motor symptoms in advanced Parkinson's disease (PD), its behavioral and psychiatric effects&#xD;
      are strongly debated, with some studies showing a worsening or new onset of behavioral and&#xD;
      psychiatric issues after STN stimulation and other showing an improvement. However, these&#xD;
      data are based mainly on case reports and retrospective series.&#xD;
&#xD;
      Recently, the investigators group has conducted a prospective study assessing behavior and&#xD;
      psychiatric symptoms in patients undergoing STN stimulation up to one year after surgery.&#xD;
      After subthalamic stimulation non-motor fluctuations improved and pathologic&#xD;
      hyperdopaminergic syndrome, i.e. behavioral addictions (including pathological gambling,&#xD;
      hypersexuality, binge eating, compulsive shopping, …), compulsive use of dopaminergic&#xD;
      treatment and dopaminergic dysregulation syndrome (defined as the association of one or more&#xD;
      behavioral addictions to compulsive use of dopaminergic treatment), disappeared. These&#xD;
      findings represent a milestone because, if confirmed, the indications of STN stimulation&#xD;
      might be extended beyond motor complications. To date, there are several long-term studies on&#xD;
      motor and cognitive effects of STN stimulation, whereas no long-term longitudinal data on&#xD;
      neuropsychiatric effects do exist. Therefore, the investigators designed a long-term&#xD;
      prospective study, assessing over 3-8 years behavioral and psychiatric effect in the same&#xD;
      cohort of patients included in the one-year study. This study will allow to better evaluate&#xD;
      the change in non-motor fluctuations and of behavioral issues in the long-term with a&#xD;
      standard management.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>
  <enrollment type="Actual">69</enrollment>
  <condition>Parkinson Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Parkinson's desesase patients included in another protocol evaluating Apathy after deep&#xD;
        brain stimulation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients included in the protocol 'Apathy'&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  NA&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>March 8, 2016</last_update_submitted>
  <last_update_submitted_qc>March 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson disease</keyword>
  <keyword>Deep brain stimulation</keyword>
  <keyword>behavior and psychiatric symptoms improvement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT01705418
org study id: 12PHR02
nct id: NCT01705418
lead sponsor: 
has dmc: No
Improvement of behavioral addictions in STN-DBS in PD: Long term follow-up
Whereas subthalamic nucleus (STN) stimulation is considered an established treatment for
      motor symptoms in advanced Parkinson's disease (PD), its behavioral and psychiatric effects
      are strongly debated, with some studies showing a worsening or new onset of behavioral and
      psychiatric issues after STN stimulation and other showing an improvement. However, these
      data are based mainly on case reports and retrospective series.

      Recently, the investigators group has conducted a prospective study assessing behavior and
      psychiatric symptoms in patients undergoing STN stimulation up to one year after surgery.
      After subthalamic stimulation non-motor fluctuations improved and pathologic
      hyperdopaminergic syndrome, i.e. behavioral addictions (including pathological gambling,
      hypersexuality, binge eating, compulsive shopping, …), compulsive use of dopaminergic
      treatment and dopaminergic dysregulation syndrome (defined as the association of one or more
      behavioral addictions to compulsive use of dopaminergic treatment), disappeared. These
      findings represent a milestone because, if confirmed, the indications of STN stimulation
      might be extended beyond motor complications. To date, there are several long-term studies on
      motor and cognitive effects of STN stimulation, whereas no long-term longitudinal data on
      neuropsychiatric effects do exist. Therefore, the investigators designed a long-term
      prospective study, assessing over 3-8 years behavioral and psychiatric effect in the same
      cohort of patients included in the one-year study. This study will allow to better evaluate
      the change in non-motor fluctuations and of behavioral issues in the long-term with a
      standard management.
observational model: Cohort
time perspective: Prospective
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: No