xml: <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/NCT06019793</url>
    </required_header>
    <id_info>
      <org_study_id>22-500-326-30-06</org_study_id>
      <nct_id>NCT06019793</nct_id>
    </id_info>
    <brief_title>Electrophysiological Recordings From Deep Brain Stimulation Electrodes for Pain</brief_title>
    <acronym>EPR Pain</acronym>
    <official_title>Electrophysiological Recordings From Deep Brain Stimulation Electrodes for Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>St. Joseph's Hospital and Medical Center, Phoenix</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>St. Joseph's Hospital and Medical Center, Phoenix</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Over the last 30 years, deep brain stimulation (DBS) has allowed tens of thousands of&#xD;
        patients to receive relief of neurological symptoms that were refractory to standard medical&#xD;
        treatment. Furthermore, by providing a rare window into the electrophysiological activity of&#xD;
        the awake, human brain, DBS has facilitated invaluable advances in scientific understanding.&#xD;
        These advances have then, in turn, allowed for further therapies to be developed for an ever&#xD;
        growing population of patients that benefit from DBS therapy. This study hopes to add to this&#xD;
        growing body of knowledge by implanting leads within, and recording from, the sensory&#xD;
        thalamus and periaqueductal gray (PAG) in patients with chronic pain. Specifically, we hope&#xD;
        to establish the long-term safety of DBS leads within the periaqueductal gray and sensory&#xD;
        thalamus for the treatment of chronic pain. Furthermore, by recording from the electrodes of&#xD;
        DBS patients implanted for treatment of their chronic pain, we hope to understand how the&#xD;
        pain network responds to sensory stimuli and how DBS changes this response.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 30, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Safety of DBS for Chronic Pain as Assessed by Incidence of Treatment-Related Adverse Events</measure>
      <time_frame>2 years</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Localized Brain Activity in Relation to DBS Effect</measure>
      <time_frame>2 years</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Chronic Pain</condition>
    <arm_group>
      <arm_group_label>DBS for Chronic Pain</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>DBS for Chronic Pain</intervention_name>
      <description>Participants ill receive deep brain stimulation to relieve their chronic pain symptoms.</description>
      <arm_group_label>DBS for Chronic Pain</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients who have intractable pain, as defined by: chronic (&gt;1 year), severe (VAS&#xD;
               score &gt; 6/10), and persistent (not responsive to medication or relevant surgical&#xD;
               options) without cognitive impairment or comorbidities affecting surgical risk.&#xD;
  &#xD;
            2. Patients that have been medically cleared for DBS surgery by the consensus committee.&#xD;
  &#xD;
            3. Not exhibiting significant distress, anxiety, or psychological disturbance that may be&#xD;
               worsened due to externalized leads or potential complications or by study recording or&#xD;
               tasks.&#xD;
  &#xD;
            4. Motorically and cognitively capable of completing evaluations and consent.&#xD;
  &#xD;
            5. Motorically and cognitively capable of participating in the study's computer-based&#xD;
               tasks.&#xD;
  &#xD;
            6. Informed consent signed by the subject.&#xD;
  &#xD;
            7. Patient age between 22 to 75 years old.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients that are not a candidate for DBS. This may occur for example, if they are&#xD;
               unable to properly operate the neurostimulator. Also, several medical procedures and&#xD;
               studies are not compatible with DBS. These include diathermy, transcranial magnetic&#xD;
               stimulation, MRI procedures using radio-frequency coils, electroconvulsive therapy.&#xD;
               Patients are receiving these treatments or plan to receive them in the future will not&#xD;
               be eligible. Also, the safety of DBS has not been established for patients with a&#xD;
               previous surgical ablation, dementia, coagulopathies, moderate to severe depression,&#xD;
               or patients who are pregnant. Patients with these conditions will also not be&#xD;
               eligible. Finally, DBS may be affected by or may affect other medical devices&#xD;
               including cardiac pacemakers/defibrillator, ultrasonic equipment, radiation therapy,&#xD;
               and incomplete (abandoned) prior DBS systems. Patients with these conditions/devices&#xD;
               will not be eligible for the study.&#xD;
  &#xD;
            2. Subjects who have pain that is not severe enough to be considered for DBS: shorter&#xD;
               than 1 year duration, VAS score &lt; 6/10), responsive to medication or relevant surgical&#xD;
               options.&#xD;
  &#xD;
            3. Subjects deemed to have a psychiatric illness that would potentially interfere or&#xD;
               cause undue stress during the awake implantation surgery, the 1-3 week stimulation&#xD;
               trial period, or the long term care of the DBS system are ineligible to undergo the&#xD;
               DBS implantation procedure and thus would not be able to participate in this trial.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>22 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Markey Olson, MS</last_name>
      <phone>4802660913</phone>
      <email>markey.olson@dignityhealth.org</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 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>Chronic Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06019793
  org study id: 22-500-326-30-06
  nct id: NCT06019793
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  Over the last 30 years, deep brain stimulation (DBS) has allowed tens of thousands of
        patients to receive relief of neurological symptoms that were refractory to standard medical
        treatment. Furthermore, by providing a rare window into the electrophysiological activity of
        the awake, human brain, DBS has facilitated invaluable advances in scientific understanding.
        These advances have then, in turn, allowed for further therapies to be developed for an ever
        growing population of patients that benefit from DBS therapy. This study hopes to add to this
        growing body of knowledge by implanting leads within, and recording from, the sensory
        thalamus and periaqueductal gray (PAG) in patients with chronic pain. Specifically, we hope
        to establish the long-term safety of DBS leads within the periaqueductal gray and sensory
        thalamus for the treatment of chronic pain. Furthermore, by recording from the electrodes of
        DBS patients implanted for treatment of their chronic pain, we hope to understand how the
        pain network responds to sensory stimuli and how DBS changes this response.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Safety of DBS for Chronic Pain as Assessed by Incidence of Treatment-Related Adverse Events
  time frame: 2 years
  measure: Localized Brain Activity in Relation to DBS Effect
  time frame: 2 years
  arm group label: DBS for Chronic Pain
  arm group type: Experimental
  intervention type: Device
  intervention name: DBS for Chronic Pain
  description: Participants ill receive deep brain stimulation to relieve their chronic pain symptoms.
  arm group label: DBS for Chronic Pain
  criteria: 
  gender: All
  minimum age: 22 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Markey Olson, MS
  phone: 4802660913
  email: markey.olson@dignityhealth.org
  responsible party type: Sponsor
  mesh term: Chronic Pain
  sharing ipd: No