<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/NCT02249715</url>
  </required_header>
  <id_info>
    <org_study_id>SHEBA-1293-14-OC-CTIL</org_study_id>
    <nct_id>NCT02249715</nct_id>
  </id_info>
  <brief_title>Development of a Monitoring Set-up and Algorithm Using Functional MRI (fMRI) and EEG for Prediction of Response to Repetitive Deep Transcranial Magnetic Stimulation (rDTMS) for Patients With Parkinson's Disease</brief_title>
  <official_title>Pilot Study for Development of a Monitoring Set-up and Algorithm Using Functional MRI (fMRI) and EEG for Prediction of Response to Repetitive Deep Transcranial Magnetic Stimulation (rDTMS) for Patients With Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Brainsway</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>ElMindA Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sheba Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  To characterize physiological biomarkers of positive response to rDTMS using EEG and&#xD;
           functional MRI (fMRI) in patients with PD.&#xD;
&#xD;
        -  To develop a set-up and algorithm for neurophysiological monitoring for PD patients&#xD;
           using EEG and fMRI in patients treated by rDTMS.&#xD;
&#xD;
        -  To integrate rDTMS stimulation with monitoring techniques with the ultimate goal of&#xD;
           providing closed-loop feedback where monitoring informs the stimulation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PD Patients aged 40 years or older, diagnosed as idiopathic PD according to the UK Brain Bank&#xD;
      criteria will be treated by an established rDTMS protocol will be monitored before, during&#xD;
      and after rDTMS using quantitative EEG and brain network analysis and fMRI while performing a&#xD;
      series of cognitive and motor tasks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2014</start_date>
  <primary_completion_date type="Anticipated">December 2015</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>Unified Parkinson's Disease Rating Scale (UPDRS)</measure>
    <time_frame>3 month</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Parkinson</condition>
  <arm_group>
    <arm_group_label>rDTMS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Brainsway Multiway deep TMS device (two channels)</intervention_name>
    <arm_group_label>rDTMS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Idiopathic PD patients aged 40-75 years;&#xD;
&#xD;
          2. Hoehn and Yahr stages II to IV&#xD;
&#xD;
          3. Patients on stable antiparkinsonian therapy for 1 month&#xD;
&#xD;
          4. Right hand dominance with right afflicted side.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participation in current clinical study or clinical study within 30 days prior to this&#xD;
             study.&#xD;
&#xD;
          2. Subject has an atypical parkinsonian syndrome or secondary parkinsonism (e.g., due to&#xD;
             drugs, metabolic neurogenetic disorders, encephalitis, cerebrovascular disease or&#xD;
             other degenerative disease)&#xD;
&#xD;
          3. Patients with significant psychiatric symptoms or history.&#xD;
&#xD;
          4. Patients with psychotic symptoms or active depressive symptoms&#xD;
&#xD;
          5. Treatment with neuroleptics.&#xD;
&#xD;
          6. Beck depression inventory (BDI) score &lt;14&#xD;
&#xD;
          7. Mini Mental status examination (MMSE) score &lt;25&#xD;
&#xD;
          8. History of migraine or frequent or severe headaches.&#xD;
&#xD;
          9. Significant sensory deficits, e.g., deafness or blindness History of head injury or&#xD;
             neurosurgical interventions.&#xD;
&#xD;
         10. Subjects who have concomitant epilepsy, a history of seizure/s, heat convulsions or&#xD;
             history of epilepsy in first degree relative.&#xD;
&#xD;
         11. History of any metal in the head (outside the mouth).&#xD;
&#xD;
         12. The presence of cochlear implants&#xD;
&#xD;
         13. Known history of any metallic particles in the eye, implanted cardiac pacemaker,&#xD;
             implanted neurostimulators, surgical clips (above the shoulder line) or any medical&#xD;
             pumps.&#xD;
&#xD;
         14. Subjects with an unstable medical disorder.&#xD;
&#xD;
         15. Current drug abuse (including Cannabis) or alcoholism.&#xD;
&#xD;
         16. Pregnancy or not using a reliable method of birth control.&#xD;
&#xD;
         17. Patients with severe tremor or dyskinesia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Oren Cohen, M.D</last_name>
    <phone>972-3-5305296</phone>
    <email>Oren.Cohen@sheba.health.gov.il</email>
  </overall_contact>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>September 23, 2014</last_update_submitted>
  <last_update_submitted_qc>September 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson</keyword>
  <keyword>TMS</keyword>
  <keyword>BNA</keyword>
  <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>


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/NCT02249715
org study id: SHEBA-1293-14-OC-CTIL
nct id: NCT02249715
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
-  To characterize physiological biomarkers of positive response to rDTMS using EEG and
           functional MRI (fMRI) in patients with PD.

        -  To develop a set-up and algorithm for neurophysiological monitoring for PD patients
           using EEG and fMRI in patients treated by rDTMS.

        -  To integrate rDTMS stimulation with monitoring techniques with the ultimate goal of
           providing closed-loop feedback where monitoring informs the stimulation
PD Patients aged 40 years or older, diagnosed as idiopathic PD according to the UK Brain Bank
      criteria will be treated by an established rDTMS protocol will be monitored before, during
      and after rDTMS using quantitative EEG and brain network analysis and fMRI while performing a
      series of cognitive and motor tasks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Unified Parkinson's Disease Rating Scale (UPDRS)
time frame: 3 month
arm group label: rDTMS
arm group type: Experimental
intervention type: Device
intervention name: Brainsway Multiway deep TMS device (two channels)
arm group label: rDTMS
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Oren Cohen, M.D
phone: 972-3-5305296
email: Oren.Cohen@sheba.health.gov.il
responsible party type: Sponsor
mesh term: Parkinson Disease