<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/NCT02221544</url>
  </required_header>
  <id_info>
    <org_study_id>TASMC-13-NG-599-CTIL</org_study_id>
    <nct_id>NCT02221544</nct_id>
  </id_info>
  <brief_title>The Effect of Low-frequency rTMS on Motor Function in PD Patients With Freezing of Gait</brief_title>
  <official_title>The Effect of Low-frequency Repetitive Transcranial Magnetic Stimulation on Motor Function in Patients With Parkinson's Disease (PD) With Freezing of Gait (FOG).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tel-Aviv Sourasky Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a double blind comparative study examining the effectiveness of the rTMS&#xD;
      treatment on Freezing of Gait (FOG) phenomenon in patients with Parkinson's disease. We&#xD;
      hypothesize that treatment using rTMS stimulation on frontal lobe areas will improve gait&#xD;
      quality and decrease the frequency of FOG in patients with Parkinson's disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A course of low-frequency repetitive transcranial magnetic stimulation (rTMS) delivered over&#xD;
      the supplementary motor area (SMA) improves motor symptoms in patients with Parkinson's&#xD;
      disease (PD).&#xD;
&#xD;
      The present study is a comparative study that examines the effectiveness of rTMS treatment&#xD;
      technique Freezing of Gait (FOG) phenomenon in Parkinson's disease patients. We hypothesize&#xD;
      that treatment using rTMS stimulation on frontal areas will decreasing frequency of FOGs in&#xD;
      patients with Parkinson's disease and improve gait quality and quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">December 2016</completion_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>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in frequency and severity of the freezing of gait phenomenon</measure>
    <time_frame>One week post intervention</time_frame>
    <description>The new version of the Freezing of Gait questionnaire will be used to quantify the frequency and severity of this symptom. The score will be compared to baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Community ambulation</measure>
    <time_frame>One week post intervention</time_frame>
    <description>Will be assessed using 1) the Habitual Physical Activity Questionnaire (HPAQ). It will quantify the type and amount of regular physical activity. 2) A body-worn small lightweight device that will be worn by the subject for 7 days to monitor stepping and physical activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in endurance</measure>
    <time_frame>One week post intervention</time_frame>
    <description>This measure will be assessed using the 2 minute walk test. The distance walked during 2 minutes will be compared to baseline performance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Balance</measure>
    <time_frame>One week post intervention</time_frame>
    <description>Balance and lower extremity function will be assessed using performance-based measures: (1) The Four Square Step Test (FSST), (2) The Short Physical Performance Battery (SPPB), and (3) The Mini- Balance Evaluation Systems Test (mini-BEST).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immediate changes in blood pressure</measure>
    <time_frame>Every session, immediately after receiving the treatment</time_frame>
    <description>Measuring blood pressure will monitor subjects' autonomic response to the treatment. Measures will be compared before and after receiving the treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immediate change in gait function</measure>
    <time_frame>One week post intervention</time_frame>
    <description>Gait speed and variability will be assessed under usual and dual task conditions and while negotiating physical obstacles, using a sensorized 7 meter carpet (PKMAS) and wearable body fixed sensors. These measures will be compared to baseline performance.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>rTMS treatment followed by Sham</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A course of low-frequency repetitive transcranial magnetic stimulation (rTMS) delivered over the supplementary motor area (SMA) followed by rTMS maintenance period (1 month) and followed by sham treatment in order to show the efficacy of treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham treatment followed by rTMS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A course of sham followed by followed by sham maintenance period (1 month) and than followed by low-frequency repetitive transcranial magnetic stimulation (rTMS) delivered over the supplementary motor area (SMA) in order to show the effectiveness of rTMS</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Low-frequency repetitive Transcranial Magnetic Stimulation</intervention_name>
    <description>Participants will receive treatment at a frequency of 3 sessions per week for 4 weeks (12 sessions). In each session patient will receive repetitive Transcranial Magnetic Stimulation using a stimulation frequency of 10 Hz for half an hour.&#xD;
The treatment is done by attaching an electromagnetic coil to the scalp using a special hat. Each patient has a personal hat which serves him throughout the entire process. The treatment is performed without anesthesia and patient fully conscious. During the treatment he sits comfortably on a chair, meanwhile the magnetic field passes through the skull into the brain.</description>
    <arm_group_label>Sham treatment followed by rTMS</arm_group_label>
    <arm_group_label>rTMS treatment followed by Sham</arm_group_label>
    <other_name>rTMS treatment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>rTMS maintenance</intervention_name>
    <description>Same treatment as in rTMS treatment intervention, but only once a week for a month</description>
    <arm_group_label>Sham treatment followed by rTMS</arm_group_label>
    <arm_group_label>rTMS treatment followed by Sham</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham</intervention_name>
    <description>Participants will receive sham treatment at a frequency of 3 sessions per week for 4 weeks (12 sessions total) for half an hour each session. The treatment is done by attaching an electromagnetic coil to the scalp but without turning on the magnetic field.</description>
    <arm_group_label>Sham treatment followed by rTMS</arm_group_label>
    <arm_group_label>rTMS treatment followed by Sham</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham maintenance</intervention_name>
    <description>The same as Sham stimuli intervention, but once a week for a month</description>
    <arm_group_label>Sham treatment followed by rTMS</arm_group_label>
    <arm_group_label>rTMS treatment followed by Sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist.&#xD;
&#xD;
          2. The mini-mental state examination questionnaire score above 24 points.&#xD;
&#xD;
          3. Suffer from a disabling phenomenon called Freezing of Gait (FoG) (Freezing Of Gait&#xD;
             questionnaire score&gt; = 10)&#xD;
&#xD;
          4. Negative responses to the Preliminary Safety Magnetic Stimulation Treatment&#xD;
             questionnaire.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Other neurological or psychiatric disorders.&#xD;
&#xD;
          2. Severe personality disorder.&#xD;
&#xD;
          3. High Blood Pressure.&#xD;
&#xD;
          4. History of epilepsy, seizures or convulsions.&#xD;
&#xD;
          5. History of epilepsy or convulsions in first-degree relatives.&#xD;
&#xD;
          6. History of head injury or stroke.&#xD;
&#xD;
          7. Metal remains of the skull or inside the brain (outside the oral cavity).&#xD;
&#xD;
          8. Surgeries including metallic implants or known history of metal particles in the eye,&#xD;
             pacemakers, hearing devices transplantation, or medical pumps.&#xD;
&#xD;
          9. Current history of migraines for the last six months.&#xD;
&#xD;
         10. A history of drug or alcohol abuse&#xD;
&#xD;
         11. Other medical research in the time to experiment or three months ahead. -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nir Giladi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tel-Aviv Sourasky Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nir Giladi, MD</last_name>
    <phone>972-3-6974790</phone>
    <email>nirg@tlvmc.gov.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anat Mirelman, PhD</last_name>
    <phone>972-3-6974958</phone>
    <email>anatmi@tlvmc.gov.il</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Nir Giladi, MD</last_name>
      <phone>972-3-6974790</phone>
      <email>nirg@tlvmc.gov.il</email>
    </contact>
    <contact_backup>
      <last_name>Anat Mirelman, PhD</last_name>
      <phone>972-3-6974958</phone>
      <email>anatmi@tlvmc.gov.il</email>
    </contact_backup>
    <investigator>
      <last_name>Anat Mirelman, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jeff Hausdorff, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>August 19, 2014</last_update_submitted>
  <last_update_submitted_qc>August 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tel-Aviv Sourasky Medical Center</investigator_affiliation>
    <investigator_full_name>michal roll</investigator_full_name>
    <investigator_title>Director of the R&amp;D division in the Tel Aviv Sourasky Medical Center (TASMC)</investigator_title>
  </responsible_party>
  <keyword>Parkinson's disease, rTMS, Freezing of Gait</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/NCT02221544
org study id: TASMC-13-NG-599-CTIL
nct id: NCT02221544
lead sponsor: 
has dmc: No
This study is a double blind comparative study examining the effectiveness of the rTMS
      treatment on Freezing of Gait (FOG) phenomenon in patients with Parkinson's disease. We
      hypothesize that treatment using rTMS stimulation on frontal lobe areas will improve gait
      quality and decrease the frequency of FOG in patients with Parkinson's disease.
A course of low-frequency repetitive transcranial magnetic stimulation (rTMS) delivered over
      the supplementary motor area (SMA) improves motor symptoms in patients with Parkinson's
      disease (PD).

      The present study is a comparative study that examines the effectiveness of rTMS treatment
      technique Freezing of Gait (FOG) phenomenon in Parkinson's disease patients. We hypothesize
      that treatment using rTMS stimulation on frontal areas will decreasing frequency of FOGs in
      patients with Parkinson's disease and improve gait quality and quality of life.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Changes in frequency and severity of the freezing of gait phenomenon
time frame: One week post intervention
description: The new version of the Freezing of Gait questionnaire will be used to quantify the frequency and severity of this symptom. The score will be compared to baseline.
measure: Community ambulation
time frame: One week post intervention
description: Will be assessed using 1) the Habitual Physical Activity Questionnaire (HPAQ). It will quantify the type and amount of regular physical activity. 2) A body-worn small lightweight device that will be worn by the subject for 7 days to monitor stepping and physical activity.
measure: Changes in endurance
time frame: One week post intervention
description: This measure will be assessed using the 2 minute walk test. The distance walked during 2 minutes will be compared to baseline performance.
measure: Balance
time frame: One week post intervention
description: Balance and lower extremity function will be assessed using performance-based measures: (1) The Four Square Step Test (FSST), (2) The Short Physical Performance Battery (SPPB), and (3) The Mini- Balance Evaluation Systems Test (mini-BEST).
measure: Immediate changes in blood pressure
time frame: Every session, immediately after receiving the treatment
description: Measuring blood pressure will monitor subjects' autonomic response to the treatment. Measures will be compared before and after receiving the treatment
measure: Immediate change in gait function
time frame: One week post intervention
description: Gait speed and variability will be assessed under usual and dual task conditions and while negotiating physical obstacles, using a sensorized 7 meter carpet (PKMAS) and wearable body fixed sensors. These measures will be compared to baseline performance.
arm group label: rTMS treatment followed by Sham
arm group type: Experimental
description: A course of low-frequency repetitive transcranial magnetic stimulation (rTMS) delivered over the supplementary motor area (SMA) followed by rTMS maintenance period (1 month) and followed by sham treatment in order to show the efficacy of treatment
arm group label: Sham treatment followed by rTMS
arm group type: Experimental
description: A course of sham followed by followed by sham maintenance period (1 month) and than followed by low-frequency repetitive transcranial magnetic stimulation (rTMS) delivered over the supplementary motor area (SMA) in order to show the effectiveness of rTMS
intervention type: Device
intervention name: Low-frequency repetitive Transcranial Magnetic Stimulation
description: Participants will receive treatment at a frequency of 3 sessions per week for 4 weeks (12 sessions). In each session patient will receive repetitive Transcranial Magnetic Stimulation using a stimulation frequency of 10 Hz for half an hour.
The treatment is done by attaching an electromagnetic coil to the scalp using a special hat. Each patient has a personal hat which serves him throughout the entire process. The treatment is performed without anesthesia and patient fully conscious. During the treatment he sits comfortably on a chair, meanwhile the magnetic field passes through the skull into the brain.
arm group label: Sham treatment followed by rTMS
arm group label: rTMS treatment followed by Sham
other name: rTMS treatment
intervention type: Device
intervention name: rTMS maintenance
description: Same treatment as in rTMS treatment intervention, but only once a week for a month
arm group label: Sham treatment followed by rTMS
arm group label: rTMS treatment followed by Sham
intervention type: Device
intervention name: Sham
description: Participants will receive sham treatment at a frequency of 3 sessions per week for 4 weeks (12 sessions total) for half an hour each session. The treatment is done by attaching an electromagnetic coil to the scalp but without turning on the magnetic field.
arm group label: Sham treatment followed by rTMS
arm group label: rTMS treatment followed by Sham
intervention type: Device
intervention name: Sham maintenance
description: The same as Sham stimuli intervention, but once a week for a month
arm group label: Sham treatment followed by rTMS
arm group label: rTMS treatment followed by Sham
criteria: 
gender: All
minimum age: 50 Years
maximum age: 89 Years
healthy volunteers: No
last name: Nir Giladi, MD
role: Principal Investigator
affiliation: Tel-Aviv Sourasky Medical Center
last name: Nir Giladi, MD
phone: 972-3-6974790
email: nirg@tlvmc.gov.il
last name: Anat Mirelman, PhD
phone: 972-3-6974958
email: anatmi@tlvmc.gov.il
facility: 
contact: 
contact backup: 
investigator: 
investigator: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Tel-Aviv Sourasky Medical Center
investigator full name: michal roll
investigator title: Director of the R&D division in the Tel Aviv Sourasky Medical Center (TASMC)
mesh term: Parkinson Disease