<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/NCT03752502</url>
  </required_header>
  <id_info>
    <org_study_id>1.584.966</org_study_id>
    <nct_id>NCT03752502</nct_id>
  </id_info>
  <brief_title>Effects of Cerebral and Peripheral Electrical Stimulation on Conditioned Pain Modulation in Healthy Subjects.</brief_title>
  <official_title>Effects of Cerebral and Peripheral Electrical Stimulation on Conditioned Pain Modulation in Healthy Subjects.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do Piauí</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal do Piauí</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Neuromatrix pain model and new findings on pain chronification process point to a greater&#xD;
      efficacy of treatments that address central and peripheral rather than only peripheral&#xD;
      structures. Both cerebral and peripheral electrical stimulations can modulate brain areas&#xD;
      involved in pain processing. However, their effects on pain modulation systems and clinical&#xD;
      outcomes are lacking.&#xD;
&#xD;
      This study aims to investigate the efficacy of transcranial direct current stimulation (tDCS)&#xD;
      and peripheral electrical stimulation (PES) alone as well tDCS combined with PES on pressure&#xD;
      pain threshold and conditioned pain modulation in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">July 30, 2021</completion_date>
  <primary_completion_date type="Actual">November 30, 2019</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pressure pain threshold</measure>
    <time_frame>Pre and Post-test (immediately after tDCS)</time_frame>
    <description>Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Conditioned pain modulation</measure>
    <time_frame>Pre and Post-test (immediately after tDCS)</time_frame>
    <description>Conditioned pain modulation paradigms consist of the evaluation of a painful test stimulus followed by a second evaluation either at the same time as a distant, painful conditioning stimulus.&#xD;
PPT will be evaluated following a conditioning stimulus condition (hand immersion in a cold water).</description>
  </primary_outcome>
  <other_outcome>
    <measure>Anxiety</measure>
    <time_frame>Pre-test (before tDCS)</time_frame>
    <description>Visual analogue scale (VAS) for anxiety assesses anxiety symptoms that we tracked as possible confounding factor.&#xD;
The VAS for general anxiety is assessed by a horizontal 100-mm-long line. The extreme left end points to no anxiety, and the extreme right end to the worst anxiety possible.</description>
  </other_outcome>
  <other_outcome>
    <measure>Depression</measure>
    <time_frame>Pre-test (before tDCS)</time_frame>
    <description>Beck depression inventory (BDI) for depressive symptoms that we tracked as possible confounding factor.&#xD;
The BDI is a tool of self-assessment of depression using a questionnaire with 21 items whose intensity varies from 0 to 3 (higher scores indicating more depressive symptoms).</description>
  </other_outcome>
  <other_outcome>
    <measure>Pain catastrophizing</measure>
    <time_frame>Pre-test (before tDCS)</time_frame>
    <description>Catastrophizing pain scale that we tracked as possible confounding factor.&#xD;
The pain catastrophizing scale consists of 13 sentences describing pain-related thoughts or feelings. These are divided into 3 domains: rumination, magnification and helplessness.&#xD;
The total score on the questionnaire can lie between 0 - 52 where a higher score indicates higher levels of pain catastrophizing thoughts.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Cerebral stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active transcranial direct current stimulation&#xD;
tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combined stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active transcranial direct current stimulation combined with active peripheral electrical stimulation (PES)&#xD;
tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).&#xD;
PES: 20 minutes, 10Hz (frequency), 100µs (pulse duration), intensity at sensorial level.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham cerebral stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham transcranial direct current stimulation combined with active peripheral electrical stimulation (PES)&#xD;
tDCS: 20 minutes (30s ON), 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Peripheral stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active peripheral electrical stimulation (PES).&#xD;
PES: 20 minutes, 10Hz (frequency), 100µs (pulse duration), intensity at sensorial level.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transcranial direct current stimulation (tDCS)</intervention_name>
    <description>Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation (NIBS) technique that has been investigated for the management of various chronic pain conditions. However, as a monotherapy for pain relief, this therapy still has controversial results.</description>
    <arm_group_label>Cerebral stimulation</arm_group_label>
    <arm_group_label>Combined stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Peripheral electrical stimulation (PES)</intervention_name>
    <description>Peripheral electrical stimulation (PES) activates a complex neural network involving a series of neurotransmitters and receptors capable of promoting segmental and extrasegmental analgesia.</description>
    <arm_group_label>Combined stimulation</arm_group_label>
    <arm_group_label>Peripheral stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sham tDCS</intervention_name>
    <description>Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation (NIBS) technique that has been investigated for the management of various chronic pain conditions. However, as a monotherapy for pain relief, this therapy still has controversial results.</description>
    <arm_group_label>Peripheral stimulation</arm_group_label>
    <arm_group_label>Sham cerebral stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Healthy subjects without medical complaints.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Concurrent medication likely to affect cognitive performance pregnancy or possible&#xD;
        pregnancy history of drug or alcohol abuse or dependence recent head injury (in the last 3&#xD;
        months) history of seizure or stroke.&#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>Fuad Hazime, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Piaui</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Polyann Cavalcante, Msc</last_name>
    <phone>+55 86 3323-5209</phone>
    <email>polyannacavalcante@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Physical Therapy. Federal University of Piaui</name>
      <address>
        <city>Parnaíba</city>
        <state>Piauí</state>
        <zip>64202020</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Polyanna Cavalcante, Msc</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>April 29, 2021</last_update_submitted>
  <last_update_submitted_qc>April 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do Piauí</investigator_affiliation>
    <investigator_full_name>Fuad Ahmad Hazime</investigator_full_name>
    <investigator_title>Assistant Professor - Physical Therapy Department</investigator_title>
  </responsible_party>
  <!-- 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/NCT03752502
org study id: 1.584.966
nct id: NCT03752502
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The Neuromatrix pain model and new findings on pain chronification process point to a greater
      efficacy of treatments that address central and peripheral rather than only peripheral
      structures. Both cerebral and peripheral electrical stimulations can modulate brain areas
      involved in pain processing. However, their effects on pain modulation systems and clinical
      outcomes are lacking.

      This study aims to investigate the efficacy of transcranial direct current stimulation (tDCS)
      and peripheral electrical stimulation (PES) alone as well tDCS combined with PES on pressure
      pain threshold and conditioned pain modulation in healthy subjects.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Pressure pain threshold
time frame: Pre and Post-test (immediately after tDCS)
description: Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain.
measure: Conditioned pain modulation
time frame: Pre and Post-test (immediately after tDCS)
description: Conditioned pain modulation paradigms consist of the evaluation of a painful test stimulus followed by a second evaluation either at the same time as a distant, painful conditioning stimulus.
PPT will be evaluated following a conditioning stimulus condition (hand immersion in a cold water).
measure: Anxiety
time frame: Pre-test (before tDCS)
description: Visual analogue scale (VAS) for anxiety assesses anxiety symptoms that we tracked as possible confounding factor.
The VAS for general anxiety is assessed by a horizontal 100-mm-long line. The extreme left end points to no anxiety, and the extreme right end to the worst anxiety possible.
measure: Depression
time frame: Pre-test (before tDCS)
description: Beck depression inventory (BDI) for depressive symptoms that we tracked as possible confounding factor.
The BDI is a tool of self-assessment of depression using a questionnaire with 21 items whose intensity varies from 0 to 3 (higher scores indicating more depressive symptoms).
measure: Pain catastrophizing
time frame: Pre-test (before tDCS)
description: Catastrophizing pain scale that we tracked as possible confounding factor.
The pain catastrophizing scale consists of 13 sentences describing pain-related thoughts or feelings. These are divided into 3 domains: rumination, magnification and helplessness.
The total score on the questionnaire can lie between 0 - 52 where a higher score indicates higher levels of pain catastrophizing thoughts.
arm group label: Cerebral stimulation
arm group type: Experimental
description: Active transcranial direct current stimulation
tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).
arm group label: Combined stimulation
arm group type: Experimental
description: Active transcranial direct current stimulation combined with active peripheral electrical stimulation (PES)
tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).
PES: 20 minutes, 10Hz (frequency), 100µs (pulse duration), intensity at sensorial level.
arm group label: Sham cerebral stimulation
arm group type: Sham Comparator
description: Sham transcranial direct current stimulation combined with active peripheral electrical stimulation (PES)
tDCS: 20 minutes (30s ON), 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).
arm group label: Peripheral stimulation
arm group type: Experimental
description: Active peripheral electrical stimulation (PES).
PES: 20 minutes, 10Hz (frequency), 100µs (pulse duration), intensity at sensorial level.
intervention type: Procedure
intervention name: Transcranial direct current stimulation (tDCS)
description: Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation (NIBS) technique that has been investigated for the management of various chronic pain conditions. However, as a monotherapy for pain relief, this therapy still has controversial results.
arm group label: Cerebral stimulation
arm group label: Combined stimulation
intervention type: Procedure
intervention name: Peripheral electrical stimulation (PES)
description: Peripheral electrical stimulation (PES) activates a complex neural network involving a series of neurotransmitters and receptors capable of promoting segmental and extrasegmental analgesia.
arm group label: Combined stimulation
arm group label: Peripheral stimulation
intervention type: Procedure
intervention name: Sham tDCS
description: Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation (NIBS) technique that has been investigated for the management of various chronic pain conditions. However, as a monotherapy for pain relief, this therapy still has controversial results.
arm group label: Peripheral stimulation
arm group label: Sham cerebral stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fuad Hazime, PhD
role: Principal Investigator
affiliation: Federal University of Piaui
last name: Polyann Cavalcante, Msc
phone: +55 86 3323-5209
email: polyannacavalcante@gmail.com
facility: 
status: Recruiting
contact: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal do Piauí
investigator full name: Fuad Ahmad Hazime
investigator title: Assistant Professor - Physical Therapy Department