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/NCT06008717</url>
    </required_header>
    <id_info>
      <org_study_id>G220314</org_study_id>
      <nct_id>NCT06008717</nct_id>
    </id_info>
    <brief_title>Feasibility Trial of Image-Guided Subthalamic Nucleus Deep Brain Stimulation in Early-Stage Parkinson's Disease</brief_title>
    <official_title>A Prospective, Randomized Feasibility Clinical Trial Evaluating Image-Guided Bilateral Stimulation of the Dorsolateral Subthalamic Nucleus Receiving Hyperdirect (Primary Motor and Supplementary Motor Area) Input in Subjects With Early-Stage Parkinson's Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mallory Hacker, PhD, MSCI</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Vanderbilt University Medical Center</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>
        The goal of this feasibility study is to evaluate the preliminary safety and efficacy of&#xD;
        image-guided (i.e., targeting and programming the dorsolateral region of the subthalamic&#xD;
        nucleus (STN) receiving primary motor (M1) and supplementary motor area (SMA), but not&#xD;
        pre-SMA, input deep brain stimulation (DBS) in patients with early-stage Parkinson's disease&#xD;
        (PD).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2025</start_date>
    <completion_date type="Anticipated">August 30, 2029</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2029</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>Single (Outcomes Assessor)</masking>
      <masking_description>motor scores will be blindly rated by an independent movement disorders neurologist who will be unaware of treatment assignment, ON vs OFF treatment status, or visit sequence</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>frequency and severity of adverse events</measure>
      <time_frame>24 months</time_frame>
      <description>frequency or severity of adverse events</description>
    </primary_outcome>
    <primary_outcome>
      <measure>frequency and severity of adverse cognitive outcome</measure>
      <time_frame>24 months</time_frame>
      <description>decline from baseline at ≥ 1.5 SD (modest) and ≥ 2.0 (substantial) in tests comprising a comprehensive neuropsychological battery</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Stopped or Reversed Motor Progression</measure>
      <time_frame>24 months</time_frame>
      <description>proportion of subjects with stopped or reversed motor progression</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Parkinson Disease</condition>
    <arm_group>
      <arm_group_label>active image-guided subthalamic nucleus deep brain stimulation plus optimal drug therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>active subthalamic nucleus deep brain stimulation; plus optimal drug therapy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>inactive subthalamic nucleus deep brain stimulation plus optimal drug therapy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>inactive subthalamic nucleus deep brain stimulation plus optimal drug therapy</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>active subthalamic nucleus deep brain stimulation plus optimal drug therapy</intervention_name>
      <description>active subthalamic nucleus deep brain stimulation (DBS) plus optimal drug therapy</description>
      <arm_group_label>active image-guided subthalamic nucleus deep brain stimulation plus optimal drug therapy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>inactive subthalamic nucleus deep brain stimulation plus optimal drug therapy</intervention_name>
      <description>optimal drug therapy alone with DBS device turned off</description>
      <arm_group_label>inactive subthalamic nucleus deep brain stimulation plus optimal drug therapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. A clinical diagnosis of idiopathic Parkinson's disease (PD). The diagnosis will be&#xD;
               based upon the presence of at least two of the three cardinal motor signs of this&#xD;
               disorder (akinesia/bradykinesia, rest tremor, and rigidity) with at least one of the&#xD;
               signs being rest tremor or bradykinesia.&#xD;
  &#xD;
            2. Clear and dramatic beneficial response to dopaminergic therapy, defined as ≥30% in&#xD;
               UPDRS III with administration of the patient's medication during the screening&#xD;
               neurological examination.&#xD;
  &#xD;
            3. Hoehn and Yahr (H&amp;Y) stage II when OFF medication.&#xD;
  &#xD;
            4. No contraindications to surgery (i.e., subject does not have uncontrollable medical or&#xD;
               psychiatric illness; Exclusion Criteria).&#xD;
  &#xD;
            5. Age between 50 and 75 years old.&#xD;
  &#xD;
            6. Dopaminergic therapy for greater than one year and less than four years.&#xD;
  &#xD;
            7. Available for follow-up for the entire duration of the study.&#xD;
  &#xD;
            8. Informed Consent (Appendix C): The subject is willing and able to provide written&#xD;
               informed consent.&#xD;
  &#xD;
            9. MRI within normal range (Exclusion Criteria).&#xD;
  &#xD;
           10. Subjects receiving antidepressant medication used specifically for the treatment of&#xD;
               depression must be on stable doses for at least eight weeks prior to enrolling in the&#xD;
               study.&#xD;
  &#xD;
           11. Subjects must agree to maintain a stable regimen, if deemed medically appropriate by&#xD;
               the treating physician, of any psychotropic medications throughout the blinded&#xD;
               treatment phase.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Evidence of an alternative diagnosis or secondary parkinsonism, as suggested by:&#xD;
  &#xD;
                 -  Features unusual early in the clinical course (e.g., prominent postural&#xD;
                    instability, freezing phenomena, or hallucinations unrelated to medications in&#xD;
                    the first 3 years after symptom onset)&#xD;
  &#xD;
                 -  Dementia preceding motor symptoms&#xD;
  &#xD;
                 -  Neurologic signs of upper motor neuron or cerebellar involvement&#xD;
  &#xD;
                 -  Significant orthostatic hypotension unrelated to medications&#xD;
  &#xD;
                 -  Unequivocal cortical sensory loss (i.e., graphesthesia, sterognosis with intact&#xD;
                    primary sensory modalities), clear limb ideomotor apraxia, or progressive aphasia&#xD;
  &#xD;
                 -  Vertical supranuclear gaze palsy, or selective slowing of vertical saccades&#xD;
  &#xD;
                 -  Unequivocal cerebellar abnormalities on examination, such as cerebellar gait,&#xD;
                    limb ataxia, or cerebellar oculomotor abnormalities (e.g., sustained gaze-evoked&#xD;
                    nystagmus, macro square wave jerks, hypermetric saccades)&#xD;
  &#xD;
                 -  Documentation of a condition known to produce parkinsonism and plausibly&#xD;
                    connected to the subject's symptoms (e.g., MRI scan with evidence of significant&#xD;
                    brain atrophy, lacunar infarcts, or iron deposits in the putamen; history of&#xD;
                    stroke, exposure to toxins, or encephalitis; or neuroleptic use within the past 6&#xD;
                    months)&#xD;
  &#xD;
                 -  The expert evaluating physician, based on the full diagnostic assessment,&#xD;
                    believes that an alternative syndrome is more likely than PD.&#xD;
  &#xD;
            2. Uncontrolled medical condition or clinically significant medical disease that would&#xD;
               increase the risk of developing pre- or postoperative complications (e.g., significant&#xD;
               cardiac or pulmonary disease, uncontrolled hypertension).&#xD;
  &#xD;
            3. Dementia as evidenced by a Dementia Rating Score of less than 123.&#xD;
  &#xD;
            4. Diagnosis of probable behavioral variant frontotemporal dementia or primary&#xD;
               progressive aphasia.&#xD;
  &#xD;
            5. Currently active diagnosis of a major psychiatric disorder.&#xD;
  &#xD;
            6. Previous brain operation or injury.&#xD;
  &#xD;
            7. Active participation in another clinical trial for the treatment of PD.&#xD;
  &#xD;
            8. Subjects with cardiac pacemakers or medical conditions that require repeat MRI scans.&#xD;
  &#xD;
            9. Evidence of existing dyskinesias or motor fluctuations.&#xD;
  &#xD;
           10. Any current substance use disorder.&#xD;
  &#xD;
           11. Any history of recurrent or unprovoked seizures.&#xD;
  &#xD;
           12. Any prior movement disorder treatments that involved intracranial surgery or device&#xD;
               implantation.&#xD;
  &#xD;
           13. Any other active implanted intracranial device (e.g., cochlear implant) or implanted&#xD;
               device to treat movement disorders (e.g., duodopa pump) whether turned on or off.&#xD;
  &#xD;
           14. A condition requiring or likely to require the use of magnetic resonance imaging (MRI)&#xD;
               or diathermy.&#xD;
  &#xD;
           15. History of suicide attempt.&#xD;
  &#xD;
           16. A female who is breastfeeding or of child-bearing potential with a positive urine&#xD;
               pregnancy test or not using adequate contraception.&#xD;
  &#xD;
           17. Inability or unwillingness of subject to give written informed consent.&#xD;
  &#xD;
           18. Parkinsonian features restricted to the lower limbs for more than three years.&#xD;
  &#xD;
           19. Treatment with a dopamine receptor blocker or a dopamine-depleting agent in a dose and&#xD;
               time course consistent with drug-induced parkinsonism.&#xD;
  &#xD;
           20. Normal functional neuroimaging of the presynaptic dopaminergic system, as measured by&#xD;
               DaTSCAN.&#xD;
  &#xD;
           21. Rapid progression of gait impairment requiring regular use of a wheelchair.&#xD;
  &#xD;
           22. Early bulbar dysfunction, defined as one of severe dysphonia, dysarthria (speech&#xD;
               unintelligible most of the time), or dysphagia (requiring soft food, nasogastric (NG)&#xD;
               tube, or gastrostomy feeding).&#xD;
  &#xD;
           23. Inspiratory respiratory dysfunction defined as either diurnal or nocturnal inspiratory&#xD;
               stridor or frequent inspiratory sighs.&#xD;
  &#xD;
           24. Recurrent (&gt;1/year) falls because of impaired balance within 3 years of onset.&#xD;
  &#xD;
           25. Otherwise unexplained pyramidal tract signs, defined as pyramidal weakness or clear&#xD;
               pathologic hyperreflexia (excluding mild reflex asymmetry in the more affected limb&#xD;
               and isolated extensor plantar response).&#xD;
  &#xD;
           26. Bilateral symmetric parkinsonism throughout the disease course. The patient or&#xD;
               caregiver reports bilateral symptom onset with no side predominance, and no side&#xD;
               predominance is observed on objective examination.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>December 23, 2022</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
      <investigator_full_name>Mallory Hacker, PhD, MSCI</investigator_full_name>
      <investigator_title>Assistant Professor of Neurology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Parkinson Disease</mesh_term>
    </condition_browse>
    <!-- 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/NCT06008717
  org study id: G220314
  nct id: NCT06008717
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  The goal of this feasibility study is to evaluate the preliminary safety and efficacy of
        image-guided (i.e., targeting and programming the dorsolateral region of the subthalamic
        nucleus (STN) receiving primary motor (M1) and supplementary motor area (SMA), but not
        pre-SMA, input deep brain stimulation (DBS) in patients with early-stage Parkinson's disease
        (PD).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: motor scores will be blindly rated by an independent movement disorders neurologist who will be unaware of treatment assignment, ON vs OFF treatment status, or visit sequence
  measure: frequency and severity of adverse events
  time frame: 24 months
  description: frequency or severity of adverse events
  measure: frequency and severity of adverse cognitive outcome
  time frame: 24 months
  description: decline from baseline at ≥ 1.5 SD (modest) and ≥ 2.0 (substantial) in tests comprising a comprehensive neuropsychological battery
  measure: Stopped or Reversed Motor Progression
  time frame: 24 months
  description: proportion of subjects with stopped or reversed motor progression
  arm group label: active image-guided subthalamic nucleus deep brain stimulation plus optimal drug therapy
  arm group type: Experimental
  description: active subthalamic nucleus deep brain stimulation; plus optimal drug therapy
  arm group label: inactive subthalamic nucleus deep brain stimulation plus optimal drug therapy
  arm group type: Active Comparator
  description: inactive subthalamic nucleus deep brain stimulation plus optimal drug therapy
  intervention type: Device
  intervention name: active subthalamic nucleus deep brain stimulation plus optimal drug therapy
  description: active subthalamic nucleus deep brain stimulation (DBS) plus optimal drug therapy
  arm group label: active image-guided subthalamic nucleus deep brain stimulation plus optimal drug therapy
  intervention type: Device
  intervention name: inactive subthalamic nucleus deep brain stimulation plus optimal drug therapy
  description: optimal drug therapy alone with DBS device turned off
  arm group label: inactive subthalamic nucleus deep brain stimulation plus optimal drug therapy
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 75 Years
  healthy volunteers: No
  responsible party type: Sponsor-Investigator
  investigator affiliation: Vanderbilt University Medical Center
  investigator full name: Mallory Hacker, PhD, MSCI
  investigator title: Assistant Professor of Neurology
  mesh term: Parkinson Disease