<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/NCT03285685</url>
  </required_header>
  <id_info>
    <org_study_id>NeuroDTM</org_study_id>
    <nct_id>NCT03285685</nct_id>
  </id_info>
  <brief_title>Effect of Noninvasive Neuromodulation on Chronic Pain</brief_title>
  <official_title>Effect of Noninvasive Neuromodulation on Chronic Pain and Anxiety Levels in Individuals With Temporomandibular Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Paraíba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Paraíba</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>
      1. BACKGROUND: Temporomandibular Dysfunction (TMD) is a disease characterized by a set of&#xD;
           signs and symptoms that may include joint noise, pain in the mastication muscles,&#xD;
           limitation of mandibular movements, facial pain, joint pain and / or dental wear. Pain&#xD;
           appears as a very present and striking symptom, with a tendency to chronicity. This is a&#xD;
           difficult treatment condition often associated with psychological factors such as&#xD;
           anxiety. Chronic pain involved modifications in the neuronal excitability, therefore,&#xD;
           the neuromodulation withTranscranial direct current stimulation (tDCS) appears as a&#xD;
           possible strategy for the treatment. Some studies have shown improvement in subjects&#xD;
           with chronic pain using tDCS, however, it needs further investigation of its therapeutic&#xD;
           effect.&#xD;
&#xD;
        2. PROBLEM: Despite the wide range of strategies used to treat patients with TMD, some&#xD;
           patients have a temporary and / or unsatisfactory relief response, which generates&#xD;
           hypotheses that emotional components often underlie treatment refractoriness, and&#xD;
           development of a memory for pain. Thus, it is evident the need for a therapy that acts&#xD;
           directly on the central nervous system (CNS). This action can occur through medications,&#xD;
           however, many individuals are refractory or have side effects such as dependence and /&#xD;
           or tolerance. In this way, the importance of new treatments involving neuromodulation&#xD;
           and neuroplasticity mechanisms, such as tDCS, is highlighted, which may become a&#xD;
           complementary alternative to the different types of treatment already in use. Besides&#xD;
           corroborating with the need to give preference to reversible and non-invasive&#xD;
           procedures.&#xD;
&#xD;
        3. HYPOTHESIS: The investigators believe that the use of anodic tDCS in the treatment of&#xD;
           patients with TMD presenting with chronic pain will have a positive effect, promoting a&#xD;
           decrease in painful symptoms through a Central Nervous System (neuromodulation) action&#xD;
           in comparison to placebo stimulation. Because of the mutual influence between pain and&#xD;
           psychological factors, it is expected that the analgesic effect will have a positive&#xD;
           effect on anxiety levels. In addition, it is believed that a more intense analgesic&#xD;
           effect occurs in the DLPF stimulation group of the cortex compared to the M1 stimulation&#xD;
           group, since this region demonstrates to be responsible for the processing of the&#xD;
           emotional component of the pain, often underlying the refractoriness to treatment&#xD;
&#xD;
        4. AIM: To evaluate and compare the efficacy of anodic tDCS, applied in different cortical&#xD;
           regions (M1 and DLPFC), in the pain and anxiety levels in individuals with chronic pain&#xD;
           due muscular TMD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">October 2, 2017</start_date>
  <completion_date type="Anticipated">February 16, 2018</completion_date>
  <primary_completion_date type="Anticipated">January 26, 2018</primary_completion_date>
  <phase>Phase 2</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in Visual Analogic Scale</measure>
    <time_frame>4 months</time_frame>
    <description>The visual analogic scale allows us to convert subjective sensations as pain on numerical data. A 10cm scale where 0cm is no pain and 10cm the worse imaginable pain, will be used and the subjects will be asked to mark a point on the scale representing their pain. This instrument will be used to compare the VAS values before and after the intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Change Scale (PGICS)</measure>
    <time_frame>4 months</time_frame>
    <description>The Patient Global Impression of Change Scale (PGICS) is an understandable, adequate, easy-to-use instrument capable of measuring the perception of change in health status and satisfaction with the treatment of individuals with chronic musculoskeletal pain. It is a one-dimensional measurement instrument in which individuals rate their improvement associated with intervention on a 7-item scale ranging from 1 (no change) to 7 (Much better).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State-Trait Anxiety Inventory</measure>
    <time_frame>4 months</time_frame>
    <description>The STAI is used to evaluate objectively both aspects of anxiety: trait and state. Thus, the anxiety state will assess the level of anxiety at the specific time the test is performed and the anxiety trait will investigate the individual's willingness to react to stress situations. It is an instrument with 40 descriptive statements about the feelings of the person, distributed in two parts (trace and state of anxiety), in which each part is formed by 20 affirmations and the answers are given in scale of the type Likert of four points (1 - absolutely not the 4 - very much). The score in each questionnaire ranges from 20 to 80, with an anxiety level rating of: low (20 to 33), mean (33 to 49) and high (49 to 80).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Temporomandibular Dysfunction (TMD)</condition>
  <arm_group>
    <arm_group_label>tDCS M1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>active tDCS Participants will receive active transcranial direct current stimulation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>tDCS DLPF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>active tDCS Participants will receive active transcranial direct current stimulation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>tDCS sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>tDCS Sham Participants will receive sham transcranial direct current stimulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>active tDCS</intervention_name>
    <description>Duration: 20 minutes; Intensity: 2 mA; Placement: anodal over left M1 and cathodal over supraorbital contralateral area</description>
    <arm_group_label>tDCS M1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>active tDCS</intervention_name>
    <description>Duration: 20 minutes; Intensity: 2 mA; Placement: anodal over left DLPFC and cathodal over supraorbital contralateral area.</description>
    <arm_group_label>tDCS DLPF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>sham tDCS</intervention_name>
    <description>The procedure is the same as for active tDCS anodal over left M1 and cathodal over supraorbital contralateral area, but the in the placebo tDCS the stimulation is non-active / sham.</description>
    <arm_group_label>tDCS sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18-60 years, both male and female&#xD;
&#xD;
          -  Provide informed consent to participate in the study;&#xD;
&#xD;
          -  Having a diagnosis of muscular pain DTM according to IA and IB, axis I RDC/TMD&#xD;
&#xD;
          -  Visual analogic scale (VAS) score from 4 to 10 for six months or longer&#xD;
&#xD;
          -  Presence of moderate depressive symptoms through SCL-90 scale evaluation of Axis II,&#xD;
             (RDC / TMD)&#xD;
&#xD;
          -  Not pregnant;&#xD;
&#xD;
          -  Not have contraindications to tDCS, such as metal implants on the head or implanted&#xD;
             brain devices;&#xD;
&#xD;
          -  Not have history of alcohol or drugs abuse within the past 6 months as self-reported&#xD;
&#xD;
          -  Not use of carbamazepine within the past 6 months as self reported&#xD;
&#xD;
          -  Not have any history of epilepsy, stroke, moderate-to-severe traumatic brain injury or&#xD;
             severe migraines&#xD;
&#xD;
          -  Not have history of neurosurgery as self-reported&#xD;
&#xD;
          -  Not have history of major psychiatric disorders such as schizophrenia and bipolar&#xD;
             disorder&#xD;
&#xD;
          -  Not have any other previously diagnosed disorder with symptoms similar to the DTM,&#xD;
             such as fibromyalgia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Two absences during treatment sessions;&#xD;
&#xD;
          -  During the research, go against some criteria of inclusion mentioned above, as in the&#xD;
             case of women, getting pregnant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Tatyanne Falcão</last_name>
    <email>pesquisadtm@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tatyanne Falcão</name>
      <address>
        <city>João Pessoa</city>
        <state>Paraíba</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>September 14, 2017</last_update_submitted>
  <last_update_submitted_qc>September 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Paraíba</investigator_affiliation>
    <investigator_full_name>Tatyanne dos Santos Falcão Silva</investigator_full_name>
    <investigator_title>Tatyanne Falcão</investigator_title>
  </responsible_party>
  <keyword>Analgesia</keyword>
  <keyword>Facial pain</keyword>
  <keyword>Transcranial Direct Current Stimulation</keyword>
  <keyword>Temporomandibular disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Temporomandibular Joint Disorders</mesh_term>
    <mesh_term>Temporomandibular Joint Dysfunction Syndrome</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <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/NCT03285685
org study id: NeuroDTM
nct id: NCT03285685
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
1. BACKGROUND: Temporomandibular Dysfunction (TMD) is a disease characterized by a set of
           signs and symptoms that may include joint noise, pain in the mastication muscles,
           limitation of mandibular movements, facial pain, joint pain and / or dental wear. Pain
           appears as a very present and striking symptom, with a tendency to chronicity. This is a
           difficult treatment condition often associated with psychological factors such as
           anxiety. Chronic pain involved modifications in the neuronal excitability, therefore,
           the neuromodulation withTranscranial direct current stimulation (tDCS) appears as a
           possible strategy for the treatment. Some studies have shown improvement in subjects
           with chronic pain using tDCS, however, it needs further investigation of its therapeutic
           effect.

        2. PROBLEM: Despite the wide range of strategies used to treat patients with TMD, some
           patients have a temporary and / or unsatisfactory relief response, which generates
           hypotheses that emotional components often underlie treatment refractoriness, and
           development of a memory for pain. Thus, it is evident the need for a therapy that acts
           directly on the central nervous system (CNS). This action can occur through medications,
           however, many individuals are refractory or have side effects such as dependence and /
           or tolerance. In this way, the importance of new treatments involving neuromodulation
           and neuroplasticity mechanisms, such as tDCS, is highlighted, which may become a
           complementary alternative to the different types of treatment already in use. Besides
           corroborating with the need to give preference to reversible and non-invasive
           procedures.

        3. HYPOTHESIS: The investigators believe that the use of anodic tDCS in the treatment of
           patients with TMD presenting with chronic pain will have a positive effect, promoting a
           decrease in painful symptoms through a Central Nervous System (neuromodulation) action
           in comparison to placebo stimulation. Because of the mutual influence between pain and
           psychological factors, it is expected that the analgesic effect will have a positive
           effect on anxiety levels. In addition, it is believed that a more intense analgesic
           effect occurs in the DLPF stimulation group of the cortex compared to the M1 stimulation
           group, since this region demonstrates to be responsible for the processing of the
           emotional component of the pain, often underlying the refractoriness to treatment

        4. AIM: To evaluate and compare the efficacy of anodic tDCS, applied in different cortical
           regions (M1 and DLPFC), in the pain and anxiety levels in individuals with chronic pain
           due muscular TMD.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change from baseline in Visual Analogic Scale
time frame: 4 months
description: The visual analogic scale allows us to convert subjective sensations as pain on numerical data. A 10cm scale where 0cm is no pain and 10cm the worse imaginable pain, will be used and the subjects will be asked to mark a point on the scale representing their pain. This instrument will be used to compare the VAS values before and after the intervention.
measure: Patient Global Impression of Change Scale (PGICS)
time frame: 4 months
description: The Patient Global Impression of Change Scale (PGICS) is an understandable, adequate, easy-to-use instrument capable of measuring the perception of change in health status and satisfaction with the treatment of individuals with chronic musculoskeletal pain. It is a one-dimensional measurement instrument in which individuals rate their improvement associated with intervention on a 7-item scale ranging from 1 (no change) to 7 (Much better).
measure: State-Trait Anxiety Inventory
time frame: 4 months
description: The STAI is used to evaluate objectively both aspects of anxiety: trait and state. Thus, the anxiety state will assess the level of anxiety at the specific time the test is performed and the anxiety trait will investigate the individual's willingness to react to stress situations. It is an instrument with 40 descriptive statements about the feelings of the person, distributed in two parts (trace and state of anxiety), in which each part is formed by 20 affirmations and the answers are given in scale of the type Likert of four points (1 - absolutely not the 4 - very much). The score in each questionnaire ranges from 20 to 80, with an anxiety level rating of: low (20 to 33), mean (33 to 49) and high (49 to 80).
arm group label: tDCS M1
arm group type: Experimental
description: active tDCS Participants will receive active transcranial direct current stimulation.
arm group label: tDCS DLPF
arm group type: Experimental
description: active tDCS Participants will receive active transcranial direct current stimulation.
arm group label: tDCS sham
arm group type: Sham Comparator
description: tDCS Sham Participants will receive sham transcranial direct current stimulation.
intervention type: Device
intervention name: active tDCS
description: Duration: 20 minutes; Intensity: 2 mA; Placement: anodal over left M1 and cathodal over supraorbital contralateral area
arm group label: tDCS M1
intervention type: Device
intervention name: active tDCS
description: Duration: 20 minutes; Intensity: 2 mA; Placement: anodal over left DLPFC and cathodal over supraorbital contralateral area.
arm group label: tDCS DLPF
intervention type: Device
intervention name: sham tDCS
description: The procedure is the same as for active tDCS anodal over left M1 and cathodal over supraorbital contralateral area, but the in the placebo tDCS the stimulation is non-active / sham.
arm group label: tDCS sham
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Tatyanne Falcão
email: pesquisadtm@yahoo.com
facility: 
status: Recruiting
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Paraíba
investigator full name: Tatyanne dos Santos Falcão Silva
investigator title: Tatyanne Falcão
mesh term: Temporomandibular Joint Disorders
mesh term: Temporomandibular Joint Dysfunction Syndrome
mesh term: Chronic Pain
sharing ipd: No