<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/NCT02236260</url>
  </required_header>
  <id_info>
    <org_study_id>RC14_0060</org_study_id>
    <nct_id>NCT02236260</nct_id>
  </id_info>
  <brief_title>Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation</brief_title>
  <acronym>ACUplus</acronym>
  <official_title>Evaluation of the Benefit Provided by the Addition of Acupunctural Analgesia With Electrostimulation to Conventional Local Anesthesia Compared to Conventional Local Anesthesia Alone in Surgery of Deep Brain Stimulation for Movement Disorders.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The effectiveness of Deep Brain Stimulation (DBS) in certain movement disorders is widely&#xD;
      demonstrated. The success of this procedure requires that the patient is awake and&#xD;
      cooperative. The conditions of this intervention can be difficult to tolerate by the patient&#xD;
      for several reasons: long procedure (from 3 to 8 hours), body immobilisation (particularly&#xD;
      the head in the stereotactic frame), stress related to the localization of the DBS. It is&#xD;
      therefore important to improve the comfort as well as the cooperation of the patient, during&#xD;
      implantation of the DBS electrodes, in order to optimize the conditions of the intervention.&#xD;
      In addition to analgesia, acupuncture should allow sedation without affecting alertness and&#xD;
      should contribute to the regulation of any vegetative reactions during the procedure.&#xD;
      Therefore, we hypothesize that acupuncture could improve the quality of care of the patient&#xD;
      during a DBS procedure. In practice, this is electroacupuncture that will be used in this&#xD;
      research to maintain the stimulation of acupuncture points to an optimal level during the&#xD;
      time of the intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 3, 2014</start_date>
  <completion_date type="Actual">June 14, 2017</completion_date>
  <primary_completion_date type="Actual">June 12, 2017</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient comfort, judged by &quot;Edmonton Symptom Assessment System&quot; scale (ESAS)</measure>
    <time_frame>The day of the DBS procedure</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient anxiety, judged by Hamilton anxiety scale (HAMA)</measure>
    <time_frame>The day before the DBS procedure, the day of the DBS procedure, 2 days after the DBS procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug consumption</measure>
    <time_frame>The day of the DBS procedure, 2 days after the DBS procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anesthesia monitoring parameters: heart rate, blood pressure, pulse oximetry</measure>
    <time_frame>The day of the DBS procedure, 2 days after the DBS procedure</time_frame>
    <description>Composite measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse effects</measure>
    <time_frame>The day before the DBS procedure,the day of the DBS procedure, 2 days after the DBS procedure</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>Local anesthesia alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Local Anesthesia + Electroacupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Electroacupuncture</intervention_name>
    <description>Acupuncture will be performed using an electrical stimulator (generating electrical stimulation) for electroacupuncture.</description>
    <arm_group_label>Local Anesthesia + Electroacupuncture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Local Anesthesia (lidocaine hydrochloride)</intervention_name>
    <description>All patients will receive injectable paracetamol for pain relief, a mix of nitrous oxide 50% and oxygen 50% for analgesia and lidocaine hydrochloride for local anesthesia.</description>
    <arm_group_label>Local Anesthesia + Electroacupuncture</arm_group_label>
    <arm_group_label>Local anesthesia alone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients from both sexes aged who are &gt;= 18 years&#xD;
&#xD;
          -  Disabling movement disorders, resistant to medical treatment, in Parkinson's patients&#xD;
             who should benefit from a Deep Brain Stimulation in the subthalamic nucleus&#xD;
&#xD;
          -  Scheduled intervention of a Deep Brain Stimulation&#xD;
&#xD;
          -  Understanding of acupunctural analgesia with electrostimulation&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  Membership to a social security insurance scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are &gt;= 75 years&#xD;
&#xD;
          -  History of intolerance to acupuncture&#xD;
&#xD;
          -  Contraindications to local anesthesia&#xD;
&#xD;
          -  Respiratory problems (asthma, COPD, ...)&#xD;
&#xD;
          -  Holder of an implanted pacemaker&#xD;
&#xD;
          -  Obesity with BMI &gt; 30&#xD;
&#xD;
          -  History of motion sickness&#xD;
&#xD;
          -  Unstabilized psychiatric disorders&#xD;
&#xD;
          -  Impaired cognitive functions&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Breastfeeding&#xD;
&#xD;
          -  Minors&#xD;
&#xD;
          -  Major under a legal protection regime&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sylvie RAOUL, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nantes University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>September 4, 2017</last_update_submitted>
  <last_update_submitted_qc>September 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2017</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>Parkinson Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_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/NCT02236260
org study id: RC14_0060
nct id: NCT02236260
lead sponsor: 
has dmc: No
The effectiveness of Deep Brain Stimulation (DBS) in certain movement disorders is widely
      demonstrated. The success of this procedure requires that the patient is awake and
      cooperative. The conditions of this intervention can be difficult to tolerate by the patient
      for several reasons: long procedure (from 3 to 8 hours), body immobilisation (particularly
      the head in the stereotactic frame), stress related to the localization of the DBS. It is
      therefore important to improve the comfort as well as the cooperation of the patient, during
      implantation of the DBS electrodes, in order to optimize the conditions of the intervention.
      In addition to analgesia, acupuncture should allow sedation without affecting alertness and
      should contribute to the regulation of any vegetative reactions during the procedure.
      Therefore, we hypothesize that acupuncture could improve the quality of care of the patient
      during a DBS procedure. In practice, this is electroacupuncture that will be used in this
      research to maintain the stimulation of acupuncture points to an optimal level during the
      time of the intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Patient comfort, judged by "Edmonton Symptom Assessment System" scale (ESAS)
time frame: The day of the DBS procedure
measure: Patient anxiety, judged by Hamilton anxiety scale (HAMA)
time frame: The day before the DBS procedure, the day of the DBS procedure, 2 days after the DBS procedure
measure: Drug consumption
time frame: The day of the DBS procedure, 2 days after the DBS procedure
measure: Anesthesia monitoring parameters: heart rate, blood pressure, pulse oximetry
time frame: The day of the DBS procedure, 2 days after the DBS procedure
description: Composite measure
measure: Adverse effects
time frame: The day before the DBS procedure,the day of the DBS procedure, 2 days after the DBS procedure
arm group label: Local anesthesia alone
arm group type: Active Comparator
arm group label: Local Anesthesia + Electroacupuncture
arm group type: Experimental
intervention type: Procedure
intervention name: Electroacupuncture
description: Acupuncture will be performed using an electrical stimulator (generating electrical stimulation) for electroacupuncture.
arm group label: Local Anesthesia + Electroacupuncture
intervention type: Drug
intervention name: Local Anesthesia (lidocaine hydrochloride)
description: All patients will receive injectable paracetamol for pain relief, a mix of nitrous oxide 50% and oxygen 50% for analgesia and lidocaine hydrochloride for local anesthesia.
arm group label: Local Anesthesia + Electroacupuncture
arm group label: Local anesthesia alone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 74 Years
healthy volunteers: No
last name: Sylvie RAOUL, MD
role: Principal Investigator
affiliation: Nantes University Hospital
facility: 
country: France
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Lidocaine