<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/NCT03785535</url>
  </required_header>
  <id_info>
    <org_study_id>PSI2017-83777-P</org_study_id>
    <nct_id>NCT03785535</nct_id>
  </id_info>
  <brief_title>Functional MRI Study of Vibrotactile Stimulation Effects in Fibromyalgia</brief_title>
  <official_title>Functional MRI Study of the Effects of Vibrotactile Sensory Stimulation on Brain Activity in Fibromyalgia Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Neurovoxel SLP</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Neurovoxel SLP</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 purpose of this study is to investigate the effects of low-intensity and prolonged&#xD;
      vibrotactile sensory stimulation on brain activity and functional connectivity in&#xD;
      fibromyalgia patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Actual">February 28, 2021</completion_date>
  <primary_completion_date type="Actual">February 28, 2021</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functional MRI measures of brain functional connectivity. A correlation scale ranging from 0 to 1 will be used.</measure>
    <time_frame>3 weeks</time_frame>
    <description>Change on brain activity rated using functional MRI measures of functional connectivity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional MRI measures of brain activity. A functional MRI signal change scale ranging from 0 to 1 will be used.</measure>
    <time_frame>3 weeks</time_frame>
    <description>Change on brain activity rated using functional MRI measures of brain activation in response to nociceptive stimulation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional MRI measures of sensory system activity. A functional MRI signal change scale ranging from 0 to 1 will be used.</measure>
    <time_frame>3 weeks</time_frame>
    <description>Change on brain activity rated using functional MRI measures of brain activation in response to non-nociceptive stimulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measured fibromyalgia symptoms using a 101-point numerical rating scale.</measure>
    <time_frame>3 weeks</time_frame>
    <description>Change on fibromyalgia symptoms (including pain, fatigue, cognitive symptoms, sleep disturbance, and general health rating). Rated using Numerical Rating 101-point Scales.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerability rated using a numerical rating scale ranging from 0 to 100 points.</measure>
    <time_frame>3 weeks</time_frame>
    <description>Tolerability index (0-100).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>Actual treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vibrotactile sensory stimulation will consist on whole-body stimulation with mechanical stimuli of pallesthetic type at high rate (2-90 Hz), low intensity and long daily duration (3h).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham treatment will be applied using identical instruments and with power and duration programmed identically. However, in this case, the output will not be the signal activating the vibration motors, but rather an electrical signal turning on an incorporated pilot light indicating that the (simulated) treatment was operating</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vibrotactile stimulation</intervention_name>
    <description>The active treatment will involve whole-body sensory stimulation with mechanical stimuli of vibrotactile (pallesthetic) type at a relatively high rate, low intensity and long duration administered at sleep time (a total daily duration of 3 h distributed within a period of 2 h at bedtime and 1 h prior to getting up). The intensity will be 30% of power at bedtime and 45% prior to getting up.</description>
    <arm_group_label>Actual treatment</arm_group_label>
    <arm_group_label>Sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. A diagnosis of fibromyalgia according to the American College of Rheumatology (ACR)&#xD;
             (Arthritis Care Res 2010;62:600-10).&#xD;
&#xD;
          2. Clinical symptoms are not a consequence of other medical disorder (although the&#xD;
             presence of other disorders is not an exclusion criterion)&#xD;
&#xD;
          3. Diagnoses established by an expert on fibromyalgia.&#xD;
&#xD;
          4. Stable treatment of chronic use.&#xD;
&#xD;
          5. Subject demonstrates an understanding of the study and a willingness to participate as&#xD;
             evidenced by voluntary written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Generalized inflammatory articular or rheumatic disease.&#xD;
&#xD;
          2. Severe, non-stable medical, endocrinological or neurological disorder.&#xD;
&#xD;
          3. Psychotic disorder or drug abuse.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital del Mar</name>
      <address>
        <city>Barcelona</city>
        <zip>8003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>March 2, 2021</last_update_submitted>
  <last_update_submitted_qc>March 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Neurovoxel SLP</investigator_affiliation>
    <investigator_full_name>Jesus Pujol</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</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/NCT03785535
org study id: PSI2017-83777-P
nct id: NCT03785535
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the effects of low-intensity and prolonged
      vibrotactile sensory stimulation on brain activity and functional connectivity in
      fibromyalgia patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Functional MRI measures of brain functional connectivity. A correlation scale ranging from 0 to 1 will be used.
time frame: 3 weeks
description: Change on brain activity rated using functional MRI measures of functional connectivity
measure: Functional MRI measures of brain activity. A functional MRI signal change scale ranging from 0 to 1 will be used.
time frame: 3 weeks
description: Change on brain activity rated using functional MRI measures of brain activation in response to nociceptive stimulation
measure: Functional MRI measures of sensory system activity. A functional MRI signal change scale ranging from 0 to 1 will be used.
time frame: 3 weeks
description: Change on brain activity rated using functional MRI measures of brain activation in response to non-nociceptive stimulation
measure: Measured fibromyalgia symptoms using a 101-point numerical rating scale.
time frame: 3 weeks
description: Change on fibromyalgia symptoms (including pain, fatigue, cognitive symptoms, sleep disturbance, and general health rating). Rated using Numerical Rating 101-point Scales.
measure: Tolerability rated using a numerical rating scale ranging from 0 to 100 points.
time frame: 3 weeks
description: Tolerability index (0-100).
arm group label: Actual treatment
arm group type: Experimental
description: Vibrotactile sensory stimulation will consist on whole-body stimulation with mechanical stimuli of pallesthetic type at high rate (2-90 Hz), low intensity and long daily duration (3h).
arm group label: Sham
arm group type: Sham Comparator
description: Sham treatment will be applied using identical instruments and with power and duration programmed identically. However, in this case, the output will not be the signal activating the vibration motors, but rather an electrical signal turning on an incorporated pilot light indicating that the (simulated) treatment was operating
intervention type: Device
intervention name: Vibrotactile stimulation
description: The active treatment will involve whole-body sensory stimulation with mechanical stimuli of vibrotactile (pallesthetic) type at a relatively high rate, low intensity and long duration administered at sleep time (a total daily duration of 3 h distributed within a period of 2 h at bedtime and 1 h prior to getting up). The intensity will be 30% of power at bedtime and 45% prior to getting up.
arm group label: Actual treatment
arm group label: Sham
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Neurovoxel SLP
investigator full name: Jesus Pujol
investigator title: Principal Investigator
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes