<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/NCT02214472</url>
  </required_header>
  <id_info>
    <org_study_id>PR(AG)200/2011</org_study_id>
    <nct_id>NCT02214472</nct_id>
  </id_info>
  <brief_title>Treatment of Rumination by Biofeedback - a Randomized Controlled Trial</brief_title>
  <official_title>Valoración Objetiva y Tratamiento de la rumiación.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitari Vall d'Hebron Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitari Vall d'Hebron Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rumination syndrome is characterized by effortless recurrent regurgitation of recently&#xD;
      ingested food into the mouth, with consequent expulsion or re-chewing and swallowing. In a&#xD;
      previous study the investigators showed that rumination is produced by an unperceived,&#xD;
      somatic response to food ingestion.&#xD;
&#xD;
      After having identified the key mechanisms of rumination, the investigators developed an&#xD;
      original EMG guided biofeedback technique with specific targets for correction, based on&#xD;
      EMG-guided control of abdomino-thoracic muscular activity, and in a pilot study the&#xD;
      investigators showed the potential effectivity of this treatment. The current aim is to&#xD;
      validate this previous uncontrolled observation by a formal placebo-controlled, randomized&#xD;
      trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Abdomino-thoracic muscle activity after a challenge meal will be recorded by EMG and the&#xD;
      signal displayed on a monitor and front in the patients: in the biofeedback group, patients&#xD;
      will be instructed to control muscle activity, whereas in the placebo group patients will&#xD;
      receive a pill of placebo. In each patient 3 sessions will be performed over a 10-day period.&#xD;
      Physiological (muscular activity by EMG) and clinical outcomes (number of rumination events&#xD;
      by questionnaires administered daily for 10 days) will be measured before and after&#xD;
      treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">October 2014</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of regurgitation episodes</measure>
    <time_frame>28 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postprandial abdominal symptoms</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Rumination Disorders</condition>
  <arm_group>
    <arm_group_label>Biofeedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Abdomino-thoracic muscle activity after a challenge meal will be recorded by EMG and the signal will be displayed on a monitor in front of the patients; in the biofeedback group, patients will be instructed to control muscle activity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo medication</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Electromyography will be recorded but not shown to the patients. Patients will take a pill of placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Biofeedback</intervention_name>
    <arm_group_label>Biofeedback</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo medication</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Rumination syndrome&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Relevant organic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fernando Azpiroz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitary vall d'Hebron</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <state>Catalunya</state>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fernando Azpiroz</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <results_reference>
    <citation>Barba E, Burri E, Accarino A, Malagelada C, Rodriguez-Urrutia A, Soldevilla A, Malagelada JR, Azpiroz F. Biofeedback-guided control of abdominothoracic muscular activity reduces regurgitation episodes in patients with rumination. Clin Gastroenterol Hepatol. 2015 Jan;13(1):100-6.e1. doi: 10.1016/j.cgh.2014.04.018. Epub 2014 Apr 24.</citation>
    <PMID>24768808</PMID>
  </results_reference>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>November 9, 2015</last_update_submitted>
  <last_update_submitted_qc>November 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rumination síndrome</keyword>
  <keyword>Regurgitation</keyword>
  <keyword>Vomiting</keyword>
  <keyword>Biofeedback</keyword>
  <keyword>Electromyography</keyword>
  <keyword>Abdominal accommodation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rumination Syndrome</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/NCT02214472
org study id: PR(AG)200/2011
nct id: NCT02214472
lead sponsor: 
has dmc: No
Rumination syndrome is characterized by effortless recurrent regurgitation of recently
      ingested food into the mouth, with consequent expulsion or re-chewing and swallowing. In a
      previous study the investigators showed that rumination is produced by an unperceived,
      somatic response to food ingestion.

      After having identified the key mechanisms of rumination, the investigators developed an
      original EMG guided biofeedback technique with specific targets for correction, based on
      EMG-guided control of abdomino-thoracic muscular activity, and in a pilot study the
      investigators showed the potential effectivity of this treatment. The current aim is to
      validate this previous uncontrolled observation by a formal placebo-controlled, randomized
      trial.
Abdomino-thoracic muscle activity after a challenge meal will be recorded by EMG and the
      signal displayed on a monitor and front in the patients: in the biofeedback group, patients
      will be instructed to control muscle activity, whereas in the placebo group patients will
      receive a pill of placebo. In each patient 3 sessions will be performed over a 10-day period.
      Physiological (muscular activity by EMG) and clinical outcomes (number of rumination events
      by questionnaires administered daily for 10 days) will be measured before and after
      treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Number of regurgitation episodes
time frame: 28 days
measure: Postprandial abdominal symptoms
time frame: 28 days
arm group label: Biofeedback
arm group type: Experimental
description: Abdomino-thoracic muscle activity after a challenge meal will be recorded by EMG and the signal will be displayed on a monitor in front of the patients; in the biofeedback group, patients will be instructed to control muscle activity.
arm group label: Placebo medication
arm group type: Placebo Comparator
description: Electromyography will be recorded but not shown to the patients. Patients will take a pill of placebo.
intervention type: Behavioral
intervention name: Biofeedback
arm group label: Biofeedback
intervention type: Drug
intervention name: Placebo
arm group label: Placebo medication
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fernando Azpiroz, MD
role: Principal Investigator
affiliation: Hospital Universitary vall d'Hebron
facility: 
facility: 
country: Spain
citation: Barba E, Burri E, Accarino A, Malagelada C, Rodriguez-Urrutia A, Soldevilla A, Malagelada JR, Azpiroz F. Biofeedback-guided control of abdominothoracic muscular activity reduces regurgitation episodes in patients with rumination. Clin Gastroenterol Hepatol. 2015 Jan;13(1):100-6.e1. doi: 10.1016/j.cgh.2014.04.018. Epub 2014 Apr 24.
PMID: 24768808
responsible party type: Sponsor
mesh term: Rumination Syndrome