<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/NCT03278184</url>
  </required_header>
  <id_info>
    <org_study_id>post tDCS</org_study_id>
    <nct_id>NCT03278184</nct_id>
  </id_info>
  <brief_title>Transcranial Direct Current Stimulation in Reduction of Pain and Postoperative Opioids Consumption After Spine Surgery</brief_title>
  <official_title>The Role of Transcranial Direct Current Stimulation in Reduction of Pain and Postoperative Opioids Consumption After Spine Surgery, Double Blinded Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The experience of pain derives from changes in brain excitability. Therefore, modulating the&#xD;
      excitability of cortical areas involved in pain processing may become an attractive option in&#xD;
      the context of multimodal analgesia during the postoperative period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The combination of analgesic drugs acting on different mechanisms can potentiate the effects&#xD;
      of analgesia. Moreover, the understanding of pain physiology at the molecular level supports&#xD;
      the development of new specific drugs. Indeed, new neurophysiological models of pain&#xD;
      processing by the brain are becoming exquisitely refined and are supported by&#xD;
      electrophysiological and functional brain imaging studies. One of the interesting concepts&#xD;
      that stemmed from these studies is the evidence that the experience of pain is reflected in&#xD;
      the central nervous system by widespread activations and excitability changes within a&#xD;
      network of interconnected cortical areas and subcortical structures. The network processing&#xD;
      of noxious information and their limbic and emotional consequences has been termed the &quot;pain&#xD;
      matrix.&quot; The continuous observation of the activity and excitability changes that parallel&#xD;
      the pain experience led to the development of a new therapeutic approach: the use of central&#xD;
      nervous system stimulation techniques.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">November 1, 2019</completion_date>
  <primary_completion_date type="Actual">April 1, 2019</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the total consumption of morphine administered by patients during the first two days postoperative</measure>
    <time_frame>48 hours postoperative</time_frame>
    <description>the investigator will calculate the amount of morphine used during the first two days postoperative.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain severity assessment using visual analogue scale (VAS score from 0-10)</measure>
    <time_frame>30 minutes after every sessions and at the third day</time_frame>
    <description>the investigator will assess the pain at base line and at the end of sessions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HADS score</measure>
    <time_frame>before surgery and at the third day</time_frame>
    <description>hospital anexiety and depression score</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>tDCS sham motor cortex</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>25 participants will have sham stimulation for 20 minutes using transcranial direct current stimulation device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active motor cortex stimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>25 participants will have active stimulation targeting the left motor cortex for 20 minutes using transcranial direct current stimulation device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>active prefrontal cortex stimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>25 participants will have active stimulation targeting the left dorsolateral prefrontal cortex for 20 minutes using transcranial direct current stimulation device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tDCS sham motor cortex</intervention_name>
    <description>the intervention 25 participants will be subjected to spine surgery then participants will be subjected to sham stimulation targeting left motor cortex area using the transcranial direct current stimulation device for 30 seconds then stop for 20 minutes.</description>
    <arm_group_label>tDCS sham motor cortex</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>active prefrontal cortex stimulation</intervention_name>
    <description>the intervention 25 participants will be subjected to spine surgery then participants will be subjected to an active stimulation targeting left dorsolateral prefrontal cortex area using the transcranial direct current stimulation device with a current intensity of 2 mA for 20 min</description>
    <arm_group_label>active prefrontal cortex stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>active motor cortex stimulation</intervention_name>
    <description>the intervention 25 participants will be subjected to spine surgery then participants will be subjected to an active stimulation targeting left motor cortex area using the transcranial direct current stimulation device with a current intensity of 2 mA for 20 min</description>
    <arm_group_label>Active motor cortex stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to give informed consent to participate in the study.&#xD;
&#xD;
          -  postoperative spine surgery patients(discectomy and/or laminectomy).&#xD;
&#xD;
          -  American society of anesthesiology scores I to II patients.&#xD;
&#xD;
        Exclusion Criteria: the participant who has any history of:&#xD;
&#xD;
          -  an adverse reaction to brain stimulation.&#xD;
&#xD;
          -  a seizure&#xD;
&#xD;
          -  an unexplained loss of consciousness&#xD;
&#xD;
          -  a stroke&#xD;
&#xD;
          -  serious head injury&#xD;
&#xD;
          -  surgery to their head&#xD;
&#xD;
          -  any brain related, neurological illnesses&#xD;
&#xD;
          -  any illness that may have caused brain injury&#xD;
&#xD;
          -  frequent or severe headaches&#xD;
&#xD;
          -  metal in your head (outside the mouth) such as shrapnel, surgical clips, or fragments&#xD;
             from welding&#xD;
&#xD;
          -  any implanted medical devices such as cardiac pacemaker's or medical pumps&#xD;
&#xD;
          -  taking any analgesic medications in the past 24 hours&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  anyone in your family has epilepsy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Saeid M Elsawy, MBBch</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saeid Metwaly Elsawy</name>
      <address>
        <city>Assiut</city>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saeid Elsawy</name>
      <address>
        <city>London</city>
        <zip>N15 4DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>December 11, 2021</last_update_submitted>
  <last_update_submitted_qc>December 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Saeid Metwaly Abouelyazid Elsawy</investigator_full_name>
    <investigator_title>Assistant lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</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/NCT03278184
org study id: post tDCS
nct id: NCT03278184
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The experience of pain derives from changes in brain excitability. Therefore, modulating the
      excitability of cortical areas involved in pain processing may become an attractive option in
      the context of multimodal analgesia during the postoperative period.
The combination of analgesic drugs acting on different mechanisms can potentiate the effects
      of analgesia. Moreover, the understanding of pain physiology at the molecular level supports
      the development of new specific drugs. Indeed, new neurophysiological models of pain
      processing by the brain are becoming exquisitely refined and are supported by
      electrophysiological and functional brain imaging studies. One of the interesting concepts
      that stemmed from these studies is the evidence that the experience of pain is reflected in
      the central nervous system by widespread activations and excitability changes within a
      network of interconnected cortical areas and subcortical structures. The network processing
      of noxious information and their limbic and emotional consequences has been termed the "pain
      matrix." The continuous observation of the activity and excitability changes that parallel
      the pain experience led to the development of a new therapeutic approach: the use of central
      nervous system stimulation techniques.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: the total consumption of morphine administered by patients during the first two days postoperative
time frame: 48 hours postoperative
description: the investigator will calculate the amount of morphine used during the first two days postoperative.
measure: Pain severity assessment using visual analogue scale (VAS score from 0-10)
time frame: 30 minutes after every sessions and at the third day
description: the investigator will assess the pain at base line and at the end of sessions
measure: HADS score
time frame: before surgery and at the third day
description: hospital anexiety and depression score
arm group label: tDCS sham motor cortex
arm group type: Sham Comparator
description: 25 participants will have sham stimulation for 20 minutes using transcranial direct current stimulation device.
arm group label: Active motor cortex stimulation
arm group type: Active Comparator
description: 25 participants will have active stimulation targeting the left motor cortex for 20 minutes using transcranial direct current stimulation device.
arm group label: active prefrontal cortex stimulation
arm group type: Active Comparator
description: 25 participants will have active stimulation targeting the left dorsolateral prefrontal cortex for 20 minutes using transcranial direct current stimulation device.
intervention type: Device
intervention name: tDCS sham motor cortex
description: the intervention 25 participants will be subjected to spine surgery then participants will be subjected to sham stimulation targeting left motor cortex area using the transcranial direct current stimulation device for 30 seconds then stop for 20 minutes.
arm group label: tDCS sham motor cortex
intervention type: Device
intervention name: active prefrontal cortex stimulation
description: the intervention 25 participants will be subjected to spine surgery then participants will be subjected to an active stimulation targeting left dorsolateral prefrontal cortex area using the transcranial direct current stimulation device with a current intensity of 2 mA for 20 min
arm group label: active prefrontal cortex stimulation
intervention type: Device
intervention name: active motor cortex stimulation
description: the intervention 25 participants will be subjected to spine surgery then participants will be subjected to an active stimulation targeting left motor cortex area using the transcranial direct current stimulation device with a current intensity of 2 mA for 20 min
arm group label: Active motor cortex stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Saeid M Elsawy, MBBch
role: Principal Investigator
affiliation: Assiut University
facility: 
facility: 
country: Egypt
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Saeid Metwaly Abouelyazid Elsawy
investigator title: Assistant lecturer
mesh term: Pain, Postoperative
sharing ipd: Undecided