<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/NCT02207582</url>
  </required_header>
  <id_info>
    <org_study_id>tRNS in depression</org_study_id>
    <nct_id>NCT02207582</nct_id>
  </id_info>
  <brief_title>Prefrontal Transcranial Random Noise Stimulation in Patients With Depression</brief_title>
  <acronym>tRNS-depr</acronym>
  <official_title>Prefrontal Transcranial Random Noise Stimulation in Patients With Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Regensburg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Regensburg</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Transcranial random noise stimulation is used to stimulate the prefrontal cortices in&#xD;
      patients with depression. It's a placebo-controlled two-arm study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Transcranial random noise stimulation (tRNS) is a non-invasive electric stimulation technique&#xD;
      of the brain which was shown to be superior effective in contrast to other electric&#xD;
      stimulation such as transcranial direct current stimulation (tDCS). These studies&#xD;
      investigated mainly healthy controls and specific tasks. Only one case report is available&#xD;
      for depression. Here we stimulate patients with depression with tRNS in a placebo-controlled&#xD;
      two-arm design. Stimulation will be done as add-on to standard therapy. Electrodes will be&#xD;
      applied over both dorsolateral prefrontal cortices which are standard target points of tDCS&#xD;
      and also transcranial magnetic stimulation in depression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    no efficacy&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 6, 2016</completion_date>
  <primary_completion_date type="Actual">October 14, 2016</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in depression severity measured by the 21-item Hamilton Depression Rating Scale (baseline (-day 3) versus end of treatment (day 19))</measure>
    <time_frame>day 3; day 19</time_frame>
    <description>Change in depression severity measured by the 21-item Hamilton Depression Rating Scale (baseline (-day 3) versus end of treatment (day 19))</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in depression severity measured by the Major Depression Inventory over the course of the trial</measure>
    <time_frame>day 10; -day 3; day 5; day 12; day 19; day 75</time_frame>
    <description>Change in depression severity measured by the Major Depression Inventory over the course of the trial</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (baseline versus end of treatment)</measure>
    <time_frame>day 3; day 19</time_frame>
    <description>Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (baseline versus end of treatment)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Clinical Global Impression Scale over the course of the trial</measure>
    <time_frame>day 3; day 5; day 12; day 19; day 75</time_frame>
    <description>Change in the Clinical Global Impression Scale over the course of the trial</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Beck Depression Inventory over the course of the trial</measure>
    <time_frame>day 3; day 5; day 12; day 19; day 75</time_frame>
    <description>Change in the Beck Depression Inventory over the course of the trial</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in alertness, working memory and divided attention over the course of the trial</measure>
    <time_frame>day 3; day 19; day 75</time_frame>
    <description>Change in alertness, working memory and divided attention over the course of the trial</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Verum Prefrontal tRNS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2mA of tRNS (DC-Stimulator, NeuroConn GmbH, Germany) with a zero offset will be applied to the left and right dorsolateral prefrontal cortex. Treatment will consist of 15 days with 20 minutes stimulation per day. Voltage will be ramped at the begin and end of a stimulation for 10 seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Prefrontal tRNS</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2mA of tRNS (DC-Stimulator, NeuroConn GmbH, Germany) with a zero offset will be applied to the left and right dorsolateral prefrontal cortex. Treatment will consist of 15 days with 20 minutes stimulation per day. Voltage will be ramped at the begin and end of a stimulation for 10 seconds. Placebo stimulation will consist of just applying the ramps at the begin and end of the stimulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Verum Prefrontal tRNS</intervention_name>
    <description>2mA of tRNS (DC-Stimulator, NeuroConn GmbH, Germany) with a zero offset will be applied to the left and right dorsolateral prefrontal cortex. Treatment will consist of 15 days with 20 minutes stimulation per day. Voltage will be ramped at the begin and end of a stimulation for 10 seconds.</description>
    <arm_group_label>Verum Prefrontal tRNS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo Prefrontal tRNS</intervention_name>
    <description>2mA of tRNS (DC-Stimulator, NeuroConn GmbH, Germany) with a zero offset will be applied to the left and right dorsolateral prefrontal cortex. Treatment will consist of 15 days with 20 minutes stimulation per day. Voltage will be ramped at the begin and end of a stimulation for 10 seconds. Placebo stimulation will consist of just applying the ramps at the begin and end of the stimulation.</description>
    <arm_group_label>Placebo Prefrontal tRNS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  episode of depression (unipolar or bipolar) ( ICD-10)&#xD;
&#xD;
          -  female or male between 18 and 70 years old&#xD;
&#xD;
          -  skills to participate in all study procedures&#xD;
&#xD;
          -  18 or more points in the Hamilton rating scale or depression&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  clinically relevant unstable internal or neurological comorbidity&#xD;
&#xD;
          -  evidence of significant brain malformations or neoplasm, head injury&#xD;
&#xD;
          -  cerebral vascular events&#xD;
&#xD;
          -  neurodegenerative disorders affecting the brain or prior brain surgery&#xD;
&#xD;
          -  metal objects in and around body that can not be removed&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  alcohol or drug abuse&#xD;
&#xD;
          -  eczema on the head&#xD;
&#xD;
          -  heart pacemaker&#xD;
&#xD;
          -  high dose tranquillizers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Berthold Langguth</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Regensburg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Regensburg</name>
      <address>
        <city>Regensburg</city>
        <zip>93053</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>June 14, 2018</last_update_submitted>
  <last_update_submitted_qc>June 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Regensburg</investigator_affiliation>
    <investigator_full_name>Berthold Langguth, MD, Ph.D.</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>depression; trns</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</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/NCT02207582
org study id: tRNS in depression
nct id: NCT02207582
lead sponsor: 
has dmc: No
Transcranial random noise stimulation is used to stimulate the prefrontal cortices in
      patients with depression. It's a placebo-controlled two-arm study.
Transcranial random noise stimulation (tRNS) is a non-invasive electric stimulation technique
      of the brain which was shown to be superior effective in contrast to other electric
      stimulation such as transcranial direct current stimulation (tDCS). These studies
      investigated mainly healthy controls and specific tasks. Only one case report is available
      for depression. Here we stimulate patients with depression with tRNS in a placebo-controlled
      two-arm design. Stimulation will be done as add-on to standard therapy. Electrodes will be
      applied over both dorsolateral prefrontal cortices which are standard target points of tDCS
      and also transcranial magnetic stimulation in depression.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change in depression severity measured by the 21-item Hamilton Depression Rating Scale (baseline (-day 3) versus end of treatment (day 19))
time frame: day 3; day 19
description: Change in depression severity measured by the 21-item Hamilton Depression Rating Scale (baseline (-day 3) versus end of treatment (day 19))
measure: Change in depression severity measured by the Major Depression Inventory over the course of the trial
time frame: day 10; -day 3; day 5; day 12; day 19; day 75
description: Change in depression severity measured by the Major Depression Inventory over the course of the trial
measure: Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (baseline versus end of treatment)
time frame: day 3; day 19
description: Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (baseline versus end of treatment)
measure: Change in the Clinical Global Impression Scale over the course of the trial
time frame: day 3; day 5; day 12; day 19; day 75
description: Change in the Clinical Global Impression Scale over the course of the trial
measure: Change in the Beck Depression Inventory over the course of the trial
time frame: day 3; day 5; day 12; day 19; day 75
description: Change in the Beck Depression Inventory over the course of the trial
measure: Change in alertness, working memory and divided attention over the course of the trial
time frame: day 3; day 19; day 75
description: Change in alertness, working memory and divided attention over the course of the trial
arm group label: Verum Prefrontal tRNS
arm group type: Experimental
description: 2mA of tRNS (DC-Stimulator, NeuroConn GmbH, Germany) with a zero offset will be applied to the left and right dorsolateral prefrontal cortex. Treatment will consist of 15 days with 20 minutes stimulation per day. Voltage will be ramped at the begin and end of a stimulation for 10 seconds.
arm group label: Placebo Prefrontal tRNS
arm group type: Placebo Comparator
description: 2mA of tRNS (DC-Stimulator, NeuroConn GmbH, Germany) with a zero offset will be applied to the left and right dorsolateral prefrontal cortex. Treatment will consist of 15 days with 20 minutes stimulation per day. Voltage will be ramped at the begin and end of a stimulation for 10 seconds. Placebo stimulation will consist of just applying the ramps at the begin and end of the stimulation.
intervention type: Device
intervention name: Verum Prefrontal tRNS
description: 2mA of tRNS (DC-Stimulator, NeuroConn GmbH, Germany) with a zero offset will be applied to the left and right dorsolateral prefrontal cortex. Treatment will consist of 15 days with 20 minutes stimulation per day. Voltage will be ramped at the begin and end of a stimulation for 10 seconds.
arm group label: Verum Prefrontal tRNS
intervention type: Device
intervention name: Placebo Prefrontal tRNS
description: 2mA of tRNS (DC-Stimulator, NeuroConn GmbH, Germany) with a zero offset will be applied to the left and right dorsolateral prefrontal cortex. Treatment will consist of 15 days with 20 minutes stimulation per day. Voltage will be ramped at the begin and end of a stimulation for 10 seconds. Placebo stimulation will consist of just applying the ramps at the begin and end of the stimulation.
arm group label: Placebo Prefrontal tRNS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Berthold Langguth
role: Principal Investigator
affiliation: University of Regensburg
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University of Regensburg
investigator full name: Berthold Langguth, MD, Ph.D.
investigator title: MD, PhD
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: No