<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/NCT04492917</url>
  </required_header>
  <id_info>
    <org_study_id>CV4 Alpha Band</org_study_id>
    <nct_id>NCT04492917</nct_id>
  </id_info>
  <brief_title>The Effect of CV4 and Sacral Technique on the Alpha Bands Power</brief_title>
  <official_title>The Effect of CV4 and Sacral Technique on the Alpha Bands Power: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Superiore di Osteopatia di Milano</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istituto Superiore di Osteopatia di Milano</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>
      Compression of the fourth ventricle (CV4), is the most studied cranial technique, commonly&#xD;
      used by Osteopathy in Cranial Field practitioners. Evidence attributed to CV4 some effects on&#xD;
      nervous system functions, however, the supporting evidence for CV4 clinical benefits is&#xD;
      promising but still poor. The osteopathic tradition considers the sacrum linked to the&#xD;
      cranium through anatomical and functional connections. To our knowledge, no studies explored&#xD;
      the potential effect of a sacral technique on brain activity as an indicator of a&#xD;
      neurophysiological connection between the occiput and sacrum. This study aims to explore this&#xD;
      effect by measuring the alpha-band activity during the application of a sacral technique (ST)&#xD;
      compared to the CV4 application.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Forty healthy volunteers will receive a combination of CV4 technique, CV4 sham, sacral&#xD;
      technique (ST) and sacral sham technique (sST).&#xD;
&#xD;
      Each session, split by a 4-hour washout, will start with 10 min of no treatment (resting&#xD;
      state), followed by two randomized interventions. Alpha EEG will be continuously recorded&#xD;
      during each intervention and 10 min after, for a total of approximately 50-60 min per&#xD;
      session.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 10, 2018</start_date>
  <completion_date type="Actual">October 25, 2018</completion_date>
  <primary_completion_date type="Actual">October 25, 2018</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Alpha EEG</measure>
    <time_frame>50 minutes</time_frame>
    <description>Quantitative EEG recording of alpha wave (8-12Hz)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Healthy</condition>
  <condition>Osteopathic Manipulation</condition>
  <arm_group>
    <arm_group_label>Cranial Technique CV4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects received a combination of the active technique (CV4) and the corresponding sham technique (shamCV4).&#xD;
CV4: the lateral angles of the occipital squama are manually approximated slightly exaggerating the posterior convexity of the occiput and taking the cranium into sustained extension. The technique ended when the osteopath perceived the still point, a condition in which the balanced membranous or ligamentous tension is achieved.&#xD;
ShamCV4: sham intervention was performed by placing the hands in the same position as the corresponding active technique, applying a light touch</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sacral Technique ST</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All subjects received a combination of the active technique (ST) and the corresponding sham technique (sST).&#xD;
ST: The subject was lying in the supine position, while the osteopath positioned the index and middle fingers of the caudal hand on either side of the subject's sacrum. Then establishes a point of balance between the coccyx and the vertex facilitating the sacral extension until the achievement of the still point.&#xD;
ShamST: sham intervention was performed by placing the hands in the same position of the corresponding active technique, applying a light touch</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CV4</intervention_name>
    <description>The osteopath was sitting at the head of the examination table, with the subject lying supine. The osteopath approximated with the hands the lateral angles of the occipital squama, taking the cranium into sustained extension. The technique ended when the osteopath perceived the still point, a condition in which the balanced membranous or ligamentous tension is achieved.</description>
    <arm_group_label>Cranial Technique CV4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ST</intervention_name>
    <description>The subject was lying in the supine position, while the osteopath positioned the index and middle fingers of the caudal hand on either side of the subject's sacrum. Then establishes a point of balance between the coccyx and the vertex facilitating the sacral extension until the achievement of the still point</description>
    <arm_group_label>Sacral Technique ST</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham CV4</intervention_name>
    <description>the sham intervention was performed by placing the hands in the same position as the corresponding active technique, applying a light touch</description>
    <arm_group_label>Cranial Technique CV4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham ST</intervention_name>
    <description>The sham intervention was performed by placing the hands in the same position as the corresponding active technique, applying a light touch</description>
    <arm_group_label>Sacral Technique ST</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age&#xD;
&#xD;
          -  Subjects had to sleep for at least 6 hours the night before the experiment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of Psychoactive or Psychotropic Substances&#xD;
&#xD;
          -  Cerebrovascular diseases&#xD;
&#xD;
          -  Recent headaches&#xD;
&#xD;
          -  Use of nicotine in the 24 hours prior to the quantitative EEG registration&#xD;
&#xD;
          -  Use of alcohol in the previous 12 hours.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pisa</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istituto Superiore di Osteopatia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro di Medicina Osteopatica</name>
      <address>
        <city>Milan</city>
        <zip>20126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>March 31, 2022</last_update_submitted>
  <last_update_submitted_qc>March 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istituto Superiore di Osteopatia di Milano</investigator_affiliation>
    <investigator_full_name>Viviana Pisa</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>EEG</keyword>
  <keyword>Alpha Rhythm</keyword>
  <keyword>CV4</keyword>
  <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/NCT04492917
org study id: CV4 Alpha Band
nct id: NCT04492917
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Compression of the fourth ventricle (CV4), is the most studied cranial technique, commonly
      used by Osteopathy in Cranial Field practitioners. Evidence attributed to CV4 some effects on
      nervous system functions, however, the supporting evidence for CV4 clinical benefits is
      promising but still poor. The osteopathic tradition considers the sacrum linked to the
      cranium through anatomical and functional connections. To our knowledge, no studies explored
      the potential effect of a sacral technique on brain activity as an indicator of a
      neurophysiological connection between the occiput and sacrum. This study aims to explore this
      effect by measuring the alpha-band activity during the application of a sacral technique (ST)
      compared to the CV4 application.
Forty healthy volunteers will receive a combination of CV4 technique, CV4 sham, sacral
      technique (ST) and sacral sham technique (sST).

      Each session, split by a 4-hour washout, will start with 10 min of no treatment (resting
      state), followed by two randomized interventions. Alpha EEG will be continuously recorded
      during each intervention and 10 min after, for a total of approximately 50-60 min per
      session.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
measure: Alpha EEG
time frame: 50 minutes
description: Quantitative EEG recording of alpha wave (8-12Hz)
arm group label: Cranial Technique CV4
arm group type: Experimental
description: All subjects received a combination of the active technique (CV4) and the corresponding sham technique (shamCV4).
CV4: the lateral angles of the occipital squama are manually approximated slightly exaggerating the posterior convexity of the occiput and taking the cranium into sustained extension. The technique ended when the osteopath perceived the still point, a condition in which the balanced membranous or ligamentous tension is achieved.
ShamCV4: sham intervention was performed by placing the hands in the same position as the corresponding active technique, applying a light touch
arm group label: Sacral Technique ST
arm group type: Active Comparator
description: All subjects received a combination of the active technique (ST) and the corresponding sham technique (sST).
ST: The subject was lying in the supine position, while the osteopath positioned the index and middle fingers of the caudal hand on either side of the subject's sacrum. Then establishes a point of balance between the coccyx and the vertex facilitating the sacral extension until the achievement of the still point.
ShamST: sham intervention was performed by placing the hands in the same position of the corresponding active technique, applying a light touch
intervention type: Other
intervention name: CV4
description: The osteopath was sitting at the head of the examination table, with the subject lying supine. The osteopath approximated with the hands the lateral angles of the occipital squama, taking the cranium into sustained extension. The technique ended when the osteopath perceived the still point, a condition in which the balanced membranous or ligamentous tension is achieved.
arm group label: Cranial Technique CV4
intervention type: Other
intervention name: ST
description: The subject was lying in the supine position, while the osteopath positioned the index and middle fingers of the caudal hand on either side of the subject's sacrum. Then establishes a point of balance between the coccyx and the vertex facilitating the sacral extension until the achievement of the still point
arm group label: Sacral Technique ST
intervention type: Other
intervention name: Sham CV4
description: the sham intervention was performed by placing the hands in the same position as the corresponding active technique, applying a light touch
arm group label: Cranial Technique CV4
intervention type: Other
intervention name: Sham ST
description: The sham intervention was performed by placing the hands in the same position as the corresponding active technique, applying a light touch
arm group label: Sacral Technique ST
criteria: 
gender: All
minimum age: 20 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pisa
role: Principal Investigator
affiliation: Istituto Superiore di Osteopatia
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Istituto Superiore di Osteopatia di Milano
investigator full name: Viviana Pisa
investigator title: Principal Investigator
sharing ipd: No