<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/NCT03233399</url>
  </required_header>
  <id_info>
    <org_study_id>16-01859</org_study_id>
    <nct_id>NCT03233399</nct_id>
  </id_info>
  <brief_title>Modulating Movement Intention Via Cortical Stimulation</brief_title>
  <official_title>Modulating Movement Intention Via Cortical Stimulation in Healthy Subjects and Patients With Psychogenic Movement Disorders and Non-epileptic Seizures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>No</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 purpose of this protocol is to learn about movement intention and volition. To improve&#xD;
      such knowledge, investigators will conduct sub-studies using multiple non-invasive&#xD;
      methodologies. These results could provide preliminary data for subsequent studies evaluating&#xD;
      local and global efficacy of plasticity-inducing treatments for PMD symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will:&#xD;
&#xD;
        -  Explore effects of TMS and tDCS on movement intention.&#xD;
&#xD;
        -  Discern the neural activity underlying modulation of movement intention with&#xD;
           neuroimaging recording.&#xD;
&#xD;
        -  Identify brain stimulation's effect in patients with psychogenic tremor and&#xD;
           non-epileptic seizures.&#xD;
&#xD;
        -  Technical development of new experimental paradigms and data analysis methods.&#xD;
&#xD;
        -  Data collection for hypotheses development.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 20, 2017</start_date>
  <completion_date type="Anticipated">May 2025</completion_date>
  <primary_completion_date type="Anticipated">May 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in signal intensity measured using of tDCS</measure>
    <time_frame>30 Minutes</time_frame>
    <description>as a result of altering cerebral perfusion in response to neurophysiologic stimulation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in signal intensity measured during EEG recording</measure>
    <time_frame>3 Hours</time_frame>
    <description>as a result of altering cerebral perfusion in response to neurophysiologic stimulation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in signal intensity measured during MEG</measure>
    <time_frame>3 Hours</time_frame>
    <description>as a result of altering cerebral perfusion in response to neurophysiologic stimulation</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Seizures</condition>
  <condition>Seizure Disorder</condition>
  <condition>Psychogenic Movement Disorder</condition>
  <arm_group>
    <arm_group_label>Healthy Patients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All healthy volunteers will complete the healthy volunteer form, MRI safety screening form, and the Montreal Cognitive Assessment (MOCA).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PMD/PNES patients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PMD and PNES subjects will be referred by the treating</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham TMS3 stimulation</intervention_name>
    <description>half of the subjects will receive sham stimulation first</description>
    <arm_group_label>Healthy Patients</arm_group_label>
    <arm_group_label>PMD/PNES patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>rTMS of left or right angular gyrus (AG) or frontal cortex (FC)</intervention_name>
    <description>Half of the subjects will receive active stimulation first; A subject may receive either TMS or tDCS stimulation, but not both, over the course of the sub-study.</description>
    <arm_group_label>Healthy Patients</arm_group_label>
    <arm_group_label>PMD/PNES patients</arm_group_label>
    <other_name>45 Minutes</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Anodal tDCS of left or right AG or FC</intervention_name>
    <description>Half of the subjects will receive active stimulation first; A subject may receive either TMS or tDCS stimulation, but not both, over the course of the sub-study.</description>
    <arm_group_label>Healthy Patients</arm_group_label>
    <arm_group_label>PMD/PNES patients</arm_group_label>
    <other_name>30 Minutes</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        (Healthy Controls)&#xD;
&#xD;
          -  Fluent in English&#xD;
&#xD;
        (Patients with PMD or PNES):&#xD;
&#xD;
          -  Diagnosis of PMD/PNES confirmed by a neurologist with expertise in movement disorders.&#xD;
&#xD;
          -  Per the treating neurologist, subject is unlikely to require treatment and/or dosage&#xD;
             changes for 3-6 months following screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any history of a significant neurological disorder, which may interfere with the&#xD;
             interpretation of study data, as determined by the PI&#xD;
&#xD;
          -  Chronic or progressive medical condition&#xD;
&#xD;
          -  Any history of traumatic brain injury or significant head trauma&#xD;
&#xD;
          -  Currently meets criteria for substance abuse or dependence&#xD;
&#xD;
          -  History of any psychotic disorder or other psychiatric condition which may interfere&#xD;
             with data interpretation&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Metal or devices in the head, including neurostimulators or metal foreign bodies&#xD;
&#xD;
          -  Any other implanted metal device, including pacemaker, spinal cord stimulator, VNS.&#xD;
&#xD;
          -  Any other ferromagnetic substance in the body that may increase study risk (including&#xD;
             dental prosthetics, etc.).&#xD;
&#xD;
          -  Taking tricyclic antidepressant or antiepileptic medications or CNS active drugs under&#xD;
             &quot;strong potential hazard&quot; list in Rossi et al., 2009&#xD;
&#xD;
          -  Current diagnosis of any inflammatory or autoimmune disorder within last 6 months&#xD;
&#xD;
        PMD and PNES Patients&#xD;
&#xD;
          -  Any history of traumatic brain injury or significant head trauma&#xD;
&#xD;
          -  Diagnosis of organic seizure disorder, including febrile seizures and tonic-clonic&#xD;
             seizures;&#xD;
&#xD;
          -  Neurological disorder other than PMD and PNES including stroke, fainting spells or&#xD;
             syncope of unknown cause(s);&#xD;
&#xD;
          -  Major or unstable medical illness, especially any current diagnosis of inflammatory or&#xD;
             autoimmune disorders within last 6 months&#xD;
&#xD;
          -  Metal or devices in the head, including neurostimulators or metal foreign bodies&#xD;
&#xD;
          -  Taking tricyclic antidepressant medications or CNS active drugs under &quot;strong&#xD;
             potential hazard&quot; list in Rossi et al., 2009;&#xD;
&#xD;
          -  Diagnosis of dementia, or Montreal Cognitive Assessment (MoCA) ≤24;&#xD;
&#xD;
          -  Recurrent visual hallucinations, within the past 6 months;&#xD;
&#xD;
          -  History of significant uncontrollable movements of the head;&#xD;
&#xD;
          -  Any clinically significant abnormality on vital signs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Biyu He, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nalini Jeet</last_name>
    <phone>(212) 263-0228</phone>
    <email>Nalini.Jeet@nyulangone.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>New York University School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Steven Stork</last_name>
      <phone>212-263-0001</phone>
      <email>steven.stork@nyumc.org</email>
    </contact>
    <investigator>
      <last_name>Biyu He, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>May 3, 2023</last_update_submitted>
  <last_update_submitted_qc>May 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Electroencephalography</keyword>
  <keyword>Magnetoencephalography</keyword>
  <keyword>Transcranial Magnetic Stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Seizures</mesh_term>
    <mesh_term>Movement Disorders</mesh_term>
    <mesh_term>Epilepsy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03233399
org study id: 16-01859
nct id: NCT03233399
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this protocol is to learn about movement intention and volition. To improve
      such knowledge, investigators will conduct sub-studies using multiple non-invasive
      methodologies. These results could provide preliminary data for subsequent studies evaluating
      local and global efficacy of plasticity-inducing treatments for PMD symptoms.
This study will:

        -  Explore effects of TMS and tDCS on movement intention.

        -  Discern the neural activity underlying modulation of movement intention with
           neuroimaging recording.

        -  Identify brain stimulation's effect in patients with psychogenic tremor and
           non-epileptic seizures.

        -  Technical development of new experimental paradigms and data analysis methods.

        -  Data collection for hypotheses development.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Changes in signal intensity measured using of tDCS
time frame: 30 Minutes
description: as a result of altering cerebral perfusion in response to neurophysiologic stimulation
measure: Changes in signal intensity measured during EEG recording
time frame: 3 Hours
description: as a result of altering cerebral perfusion in response to neurophysiologic stimulation
measure: Changes in signal intensity measured during MEG
time frame: 3 Hours
description: as a result of altering cerebral perfusion in response to neurophysiologic stimulation
arm group label: Healthy Patients
arm group type: Active Comparator
description: All healthy volunteers will complete the healthy volunteer form, MRI safety screening form, and the Montreal Cognitive Assessment (MOCA).
arm group label: PMD/PNES patients
arm group type: Active Comparator
description: PMD and PNES subjects will be referred by the treating
intervention type: Device
intervention name: Sham TMS3 stimulation
description: half of the subjects will receive sham stimulation first
arm group label: Healthy Patients
arm group label: PMD/PNES patients
intervention type: Device
intervention name: rTMS of left or right angular gyrus (AG) or frontal cortex (FC)
description: Half of the subjects will receive active stimulation first; A subject may receive either TMS or tDCS stimulation, but not both, over the course of the sub-study.
arm group label: Healthy Patients
arm group label: PMD/PNES patients
other name: 45 Minutes
intervention type: Device
intervention name: Anodal tDCS of left or right AG or FC
description: Half of the subjects will receive active stimulation first; A subject may receive either TMS or tDCS stimulation, but not both, over the course of the sub-study.
arm group label: Healthy Patients
arm group label: PMD/PNES patients
other name: 30 Minutes
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Biyu He, MD
role: Principal Investigator
affiliation: NYU Langone Health
last name: Nalini Jeet
phone: (212) 263-0228
email: Nalini.Jeet@nyulangone.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Seizures
mesh term: Movement Disorders
mesh term: Epilepsy
sharing ipd: Undecided