<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/NCT02969330</url>
  </required_header>
  <id_info>
    <org_study_id>2366-16-SMC</org_study_id>
    <nct_id>NCT02969330</nct_id>
  </id_info>
  <brief_title>Effect of Peripheral Electrical Stimulation (PES) on Brain Response to Glucose Stimuli</brief_title>
  <official_title>Effect of Short Peripheral Electrical Stimulation (PES) on Brain Response to Glucose Stimuli Evaluated by BOLD and Functional Diffusion MRI: a Crossover Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel Aviv University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tel Aviv University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aims of this study are twofold: (1) to develop an innovative approach for studying brain&#xD;
      glucose metabolism using functional diffusion weighted imaging (DWI) and BOLD fMRI in humans;&#xD;
      (2) to evaluate the effect of short peripheral electrical stimulation (PES) treatment on&#xD;
      brain and brain-stem targets, associated with control of food intake and energy expenditure,&#xD;
      in response to glucose stimuli, in healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <primary_completion_date type="Anticipated">January 2018</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in postprandial cerebral blood flow (fMRI) and cerebral diffusivity (fDWI) in response to glucose ingestion.</measure>
    <time_frame>changes from baseline to 30 minutes after glucose ingestion</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Brain Activity</condition>
  <condition>Glucose Control</condition>
  <arm_group>
    <arm_group_label>Glucose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Glucose ingestion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PES</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single session of short PES treatment before glucose ingestion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stimulator</intervention_name>
    <arm_group_label>PES</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Glucose</intervention_name>
    <description>300ml tap water with 75g glucose</description>
    <arm_group_label>Glucose</arm_group_label>
    <arm_group_label>PES</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers&#xD;
&#xD;
          -  Age 18-65 years old.&#xD;
&#xD;
          -  Body mass index 18 to 25 kg/m2&#xD;
&#xD;
          -  Capable of giving informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy, or nursing&#xD;
&#xD;
          -  Permanent pacemakers&#xD;
&#xD;
          -  Metal prosthesis&#xD;
&#xD;
          -  Skin disease&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  History of neurological disorders&#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_contact>
    <last_name>Uri Nevo, PhD</last_name>
    <phone>972-3-6407542</phone>
    <email>nevouri@post.tau.ac.il</email>
  </overall_contact>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>November 17, 2016</last_update_submitted>
  <last_update_submitted_qc>November 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tel Aviv University</investigator_affiliation>
    <investigator_full_name>Uri Nevo</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT02969330
org study id: 2366-16-SMC
nct id: NCT02969330
lead sponsor: 
collaborator: 
has dmc: No
The aims of this study are twofold: (1) to develop an innovative approach for studying brain
      glucose metabolism using functional diffusion weighted imaging (DWI) and BOLD fMRI in humans;
      (2) to evaluate the effect of short peripheral electrical stimulation (PES) treatment on
      brain and brain-stem targets, associated with control of food intake and energy expenditure,
      in response to glucose stimuli, in healthy volunteers.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Changes in postprandial cerebral blood flow (fMRI) and cerebral diffusivity (fDWI) in response to glucose ingestion.
time frame: changes from baseline to 30 minutes after glucose ingestion
arm group label: Glucose
arm group type: Experimental
description: Glucose ingestion
arm group label: PES
arm group type: Active Comparator
description: Single session of short PES treatment before glucose ingestion.
intervention type: Device
intervention name: Stimulator
arm group label: PES
intervention type: Dietary Supplement
intervention name: Glucose
description: 300ml tap water with 75g glucose
arm group label: Glucose
arm group label: PES
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Uri Nevo, PhD
phone: 972-3-6407542
email: nevouri@post.tau.ac.il
responsible party type: Principal Investigator
investigator affiliation: Tel Aviv University
investigator full name: Uri Nevo
investigator title: PhD
sharing ipd: No