<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/NCT03237754</url>
  </required_header>
  <id_info>
    <org_study_id>2016-00646</org_study_id>
    <nct_id>NCT03237754</nct_id>
  </id_info>
  <brief_title>Neurostimulation in Chronic and Episodic Migraine</brief_title>
  <official_title>Clinical and Neuronal Changes in Chronic and Episodic Migraine Patients After Neurostimulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kantonsspital Baden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Zurich</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>
      Currently, successful prevention of migraine is not sufficiently achieved by (prophylactic)&#xD;
      drug therapy. In contrast, neurophysiologically guided treatments might provide an&#xD;
      alternative avenue, since these can normalize brain alterations without side effects.&#xD;
      Transcranial direct current stimulation (tDCS) appears useful in the acute and prophylactic&#xD;
      treatment of migraine, probably because of its modifying and re-balancing influence on&#xD;
      neuronal activity. Yet, to test for the efficacy of tDCS in a clinically acceptable way, it&#xD;
      is necessary to apply not only tDCS but also a &quot;sham&quot; placebo, which is often neglected in&#xD;
      tDCS stimulation studies. Further, tDCS needs to be applied in a large (n &gt; 20) sample of&#xD;
      well-defined migraine patients, which would be advantageous, compared to previously published&#xD;
      work. Monitoring sources of regional neuronal alterations in migraineurs prior and after tDCS&#xD;
      is essential to investigate physiological mechanisms of tDCS. There is an increasing interest&#xD;
      towards non-pharmacological treatment alternatives for migraine (and headache disorders) with&#xD;
      reduced side effects to established prophylactic medications. The primary outcome of this&#xD;
      project is to demonstrate that repetitive sessions of neurostimulation lead to a significant&#xD;
      and permanent reduction of the primary symptom severity (i.e. migraine attacks) for patients&#xD;
      suffering from chronic and episodic migraine. Since neurostimulation tools are nowadays&#xD;
      accepted as therapeutic tools, our study might provide evidence that tDCS can be a&#xD;
      non-pharmacological alternative for treating migraine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruitment problems (especially for chronic migraine patients)&#xD;
  </why_stopped>
  <start_date type="Actual">October 1, 2016</start_date>
  <completion_date type="Actual">May 30, 2020</completion_date>
  <primary_completion_date type="Actual">May 30, 2020</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>
    <intervention_model_description>Patients receive either Placebo or real neurostimulation</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>double-blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Migraine days</measure>
    <time_frame>6 months</time_frame>
    <description>Change in migraine days (in episodic and chronic migraine patients) after tDCS Treatment (relative to before tDCS)Treatment) in the active and Placebo group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MR data</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in functional and structural MR data before and after tDCS Treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical data</measure>
    <time_frame>6 months</time_frame>
    <description>Clinical variables (e.g. depression scores) will be compared in an identical fashion as for the variable &quot;migraine days</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Double-blind Design</condition>
  <condition>Sham-controlled</condition>
  <condition>Randomized</condition>
  <arm_group>
    <arm_group_label>Real Neurostimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 weeks of neurostimulation (using tDCS)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Neurostimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>4 weeks of sham Treatment with the same device used for real neurostimulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tDCS device from neuroConn</intervention_name>
    <description>weak electrical direct current stimulation</description>
    <arm_group_label>Real Neurostimulation</arm_group_label>
    <arm_group_label>Sham Neurostimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients from age 18 upwards (max. 80 years) suffering from chronic or episodic migraine.&#xD;
        Medication overuse headache (MOH) patients are included as well (as chronic migraine&#xD;
        patients do often show MOH).&#xD;
&#xD;
        Healthy volunteers (18-80 years) are included if they don't fulfil the exclusion criteria&#xD;
        and do not suffer from migraine or other headache disorders, except infrequent episodic&#xD;
        tension-type headache All volunteers are able to read and sign the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients and healthy volunteers are excluded if they fulfil one of the following exclusion&#xD;
        criteria:&#xD;
&#xD;
        Common MR exclusion criteria: such as metallic items in the body (i.e. eye splinter, MR&#xD;
        incompatible implants*), pacemaker, claustrophobia or obesity (body mass index &gt; 35).&#xD;
&#xD;
        Also pregnant participants and participants suffering from a degenerative disorder of the&#xD;
        Central Nervous System, such as Stroke, Multiple Sclerosis, Parkinson's Disease,&#xD;
        Alzheimer's Disease and Huntington's Disease will be excluded. Participants with major&#xD;
        psychiatric disorders such as schizophrenia, bipolar disorder will also be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lars Michels, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Zurich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>August 26, 2020</last_update_submitted>
  <last_update_submitted_qc>August 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>migraine</keyword>
  <keyword>neurostimulation</keyword>
  <keyword>neuroimaging</keyword>
  <keyword>tDCS</keyword>
  <keyword>MRI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03237754
org study id: 2016-00646
nct id: NCT03237754
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Currently, successful prevention of migraine is not sufficiently achieved by (prophylactic)
      drug therapy. In contrast, neurophysiologically guided treatments might provide an
      alternative avenue, since these can normalize brain alterations without side effects.
      Transcranial direct current stimulation (tDCS) appears useful in the acute and prophylactic
      treatment of migraine, probably because of its modifying and re-balancing influence on
      neuronal activity. Yet, to test for the efficacy of tDCS in a clinically acceptable way, it
      is necessary to apply not only tDCS but also a "sham" placebo, which is often neglected in
      tDCS stimulation studies. Further, tDCS needs to be applied in a large (n > 20) sample of
      well-defined migraine patients, which would be advantageous, compared to previously published
      work. Monitoring sources of regional neuronal alterations in migraineurs prior and after tDCS
      is essential to investigate physiological mechanisms of tDCS. There is an increasing interest
      towards non-pharmacological treatment alternatives for migraine (and headache disorders) with
      reduced side effects to established prophylactic medications. The primary outcome of this
      project is to demonstrate that repetitive sessions of neurostimulation lead to a significant
      and permanent reduction of the primary symptom severity (i.e. migraine attacks) for patients
      suffering from chronic and episodic migraine. Since neurostimulation tools are nowadays
      accepted as therapeutic tools, our study might provide evidence that tDCS can be a
      non-pharmacological alternative for treating migraine.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients receive either Placebo or real neurostimulation
primary purpose: Basic Science
masking: Double (Participant, Investigator)
masking description: double-blind
measure: Migraine days
time frame: 6 months
description: Change in migraine days (in episodic and chronic migraine patients) after tDCS Treatment (relative to before tDCS)Treatment) in the active and Placebo group
measure: MR data
time frame: 6 months
description: Changes in functional and structural MR data before and after tDCS Treatment
measure: Clinical data
time frame: 6 months
description: Clinical variables (e.g. depression scores) will be compared in an identical fashion as for the variable "migraine days
arm group label: Real Neurostimulation
arm group type: Experimental
description: 4 weeks of neurostimulation (using tDCS)
arm group label: Sham Neurostimulation
arm group type: Sham Comparator
description: 4 weeks of sham Treatment with the same device used for real neurostimulation
intervention type: Device
intervention name: tDCS device from neuroConn
description: weak electrical direct current stimulation
arm group label: Real Neurostimulation
arm group label: Sham Neurostimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lars Michels, PhD
role: Principal Investigator
affiliation: University of Zurich
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Migraine Disorders
sharing ipd: Undecided