<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/NCT03757494</url>
  </required_header>
  <id_info>
    <org_study_id>1286051</org_study_id>
    <nct_id>NCT03757494</nct_id>
  </id_info>
  <brief_title>Cranial Electrotherapy Stimulation in the Treatment of Posttraumatic Stress Disorder</brief_title>
  <acronym>CES</acronym>
  <official_title>Cranial Electrotherapy Stimulation in the Treatment of Posttraumatic Stress Disorder: A Feasibility, Safety and Efficacy Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>White River Junction Veterans Affairs Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>White River Junction Veterans Affairs Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a research study that will look at how well a treatment called Cranial Electrotherapy&#xD;
      Stimulation (CES) works for patients who struggle with symptoms of Posttraumatic Stress&#xD;
      Disorder. Cranial Electrotherapy Stimulation is delivered using a device called Alpha-Stim®.&#xD;
      This is a safe, non-invasive treatment that applies a low-level pulsed electric current&#xD;
      through the brain using clip-on electrodes attached to the earlobes. Cranial Electrotherapy&#xD;
      Stimulation treats conditions such as physical pain, anxiety, and depression.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 18, 2018</start_date>
  <completion_date type="Actual">September 21, 2022</completion_date>
  <primary_completion_date type="Actual">September 21, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Using Alpha Stim</intervention_model_description>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of Alpha-Stim® Cranial Electrotherapy Stimulation (CES) as a treatment for Posttraumatic Stress Disorder (PTSD).</measure>
    <time_frame>1 year</time_frame>
    <description>We will deem the treatment feasible if ≥ 6 participants complete the protocol, based on completion of ≥ 60% treatments (3 out of 5 treatment days, weekly at home), and attending and completing ≥ 75% of the weekly assessments, including the week 1 baseline and week 4 treatment completion visit</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety of the Alpha-Stim® Cranial Electrotherapy Stimulation (CES) as a treatment for Posttraumatic Stress Disorder.</measure>
    <time_frame>1 year</time_frame>
    <description>Safety and tolerability, we expect this treatment to be safe, based on the very few adverse events and no serious adverse events in the literature and relative safety when compared to current pharmacologic treatments (e.g., SSRIs and SNRIs) for PTSD.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Efficacy of Alpha-Stim® Cranial Electrotherapy Stimulation (CES) as a treatment for Posttraumatic Stress Disorder.</measure>
    <time_frame>1 year</time_frame>
    <description>Efficacy, while the study isn't powered for an efficacy trial, the initial screening to baseline pretreatment to post-treatment change in the magnitude of change in PTSD symptoms (as measured by the PCL-5) during Alpha-Stim® treatment using paired t-tests can be used to determine sample size and power calculations for future studies.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>PTSD, Post Traumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>Use of Alpha Stim</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of Alpha Stim Device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Alpha Stim</intervention_name>
    <description>Use of Alpha Stim Device</description>
    <arm_group_label>Use of Alpha Stim</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. To ensure participants can safely receive Alpha-Stim®, eligible participants must meet&#xD;
             all established screening criteria for safety during Alpha-Stim® using a safety&#xD;
             screener (as assessed during phone screen and medical records review). We are&#xD;
             screening to access for metal. These are conservative measures require a patient not&#xD;
             having the following (unless MRI-safe): Cardiac pacemaker, implanted device (deep&#xD;
             brain stimulation) or metal in the brain, cervical spinal cord, or upper thoracic&#xD;
             spinal cord. The patient would additionally be required to not have an implanted&#xD;
             cardiac defibrillator;&#xD;
&#xD;
          2. Outpatients 18-70 years of age (inclusive);&#xD;
&#xD;
          3. Meet DSM-V criteria for PTSD (acute or chronic) at the time of the screening and/or&#xD;
             baseline visit; symptoms.&#xD;
&#xD;
          4. Have a baseline score of &quot;Moderately Ill&quot; or worse on the CGI-S;&#xD;
&#xD;
          5. Be on a stable psychotropic regimen for at least 6 weeks prior to baseline, or no&#xD;
             psychotropic medication at all (for at least 6 weeks prior to baseline), and be&#xD;
             willing to maintain the current regimen and dosing for the duration of the study&#xD;
             (unless medically necessary to make changes with notification of research staff);&#xD;
&#xD;
        (7) If female and of child bearing potential, agree to use an acceptable method of birth&#xD;
        control for the duration of the study treatment period; (8) Be willing and able to comply&#xD;
        with all study related procedures and visits; (9) Be capable of independently reading and&#xD;
        understanding patient information materials and giving written informed consent.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants will be excluded from participation if they meet any of the following:&#xD;
&#xD;
          1. Are pregnant or lactating or planning to become pregnant within the next three months;&#xD;
&#xD;
          2. Have a lifetime history of loss of consciousness due to head injury for greater than&#xD;
             10 minutes, or any lifetime history of loss of consciousness due to a head injury with&#xD;
             documented evidence of brain injury (including brain atrophy);&#xD;
&#xD;
          3. Current (or past if appropriate) significant neurological disorder, or lifetime&#xD;
             history of a) seizure disorder b) primary or secondary CNS tumors c) stroke or d)&#xD;
             cerebral aneurysm;&#xD;
&#xD;
          4. Unstable medical illness, or, in the opinion of the investigator, significant absence&#xD;
             of appropriate medical care;&#xD;
&#xD;
          5. Current Axis 1 primary psychotic disorder, or bipolar I disorder, active&#xD;
             moderate/severe substance use disorders (within the last month as assessed by review&#xD;
             of the medical records and veteran self-report, excluding nicotine/caffeine). Veterans&#xD;
             on stable (&gt;3 months), monitored opiate agonist therapy may be included at the&#xD;
             investigator's discretion;&#xD;
&#xD;
          6. Past failed treatment with rTMS or ECT; any past treatment with deep brain stimulation&#xD;
             or vagus nerve stimulation;&#xD;
&#xD;
          7. Have active suicidal intent or plan as detected on screening assessments, or in the&#xD;
             Investigator's opinion, is likely to attempt suicide within the next six months;&#xD;
&#xD;
          8. Mental retardation or cognitive impairment&#xD;
&#xD;
          9. History of stroke, Parkinson's Disease, Multiple Sclerosis, or seizures&#xD;
&#xD;
         10. Current use of Transcutaneous electrical nerve stimulation (TENS) unit&#xD;
&#xD;
         11. Previous history of Alpha-Stim® use&#xD;
&#xD;
         12. Inability to read and write in English&#xD;
&#xD;
         13. Incapacity to make informed medical decisions for any reason&#xD;
&#xD;
         14. Pregnancy: Pregnant women are not eligible for the study. Women with potential for&#xD;
             pregnancy will receive a pregnancy test provided by the VA prior to the study. Women&#xD;
             of childbearing capacity are eligible for the study. Contraceptive plans will be&#xD;
             discussed and if they are determined to be inadequate, the participant will be&#xD;
             excluded from the study.&#xD;
&#xD;
         15. Presence of an implanted defibrillator or pacemaker device.&#xD;
&#xD;
         16. Demonstrate the presence of any other condition or circumstance that, in the opinion&#xD;
             of the investigator, has the potential to prevent study completion and/or to have a&#xD;
             confounding effect on outcome assessments.&#xD;
&#xD;
             -&#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>James K Rustad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>White River Junction Veterans Affairs Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>White River Junction VAMC</name>
      <address>
        <city>White River Junction</city>
        <state>Vermont</state>
        <zip>05009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>October 17, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>January 27, 2023</last_update_submitted>
  <last_update_submitted_qc>January 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>White River Junction Veterans Affairs Medical Center</investigator_affiliation>
    <investigator_full_name>James Rustad</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>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</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/NCT03757494
org study id: 1286051
nct id: NCT03757494
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
This is a research study that will look at how well a treatment called Cranial Electrotherapy
      Stimulation (CES) works for patients who struggle with symptoms of Posttraumatic Stress
      Disorder. Cranial Electrotherapy Stimulation is delivered using a device called Alpha-Stim®.
      This is a safe, non-invasive treatment that applies a low-level pulsed electric current
      through the brain using clip-on electrodes attached to the earlobes. Cranial Electrotherapy
      Stimulation treats conditions such as physical pain, anxiety, and depression.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Using Alpha Stim
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Feasibility of Alpha-Stim® Cranial Electrotherapy Stimulation (CES) as a treatment for Posttraumatic Stress Disorder (PTSD).
time frame: 1 year
description: We will deem the treatment feasible if ≥ 6 participants complete the protocol, based on completion of ≥ 60% treatments (3 out of 5 treatment days, weekly at home), and attending and completing ≥ 75% of the weekly assessments, including the week 1 baseline and week 4 treatment completion visit
measure: Safety of the Alpha-Stim® Cranial Electrotherapy Stimulation (CES) as a treatment for Posttraumatic Stress Disorder.
time frame: 1 year
description: Safety and tolerability, we expect this treatment to be safe, based on the very few adverse events and no serious adverse events in the literature and relative safety when compared to current pharmacologic treatments (e.g., SSRIs and SNRIs) for PTSD.
measure: Efficacy of Alpha-Stim® Cranial Electrotherapy Stimulation (CES) as a treatment for Posttraumatic Stress Disorder.
time frame: 1 year
description: Efficacy, while the study isn't powered for an efficacy trial, the initial screening to baseline pretreatment to post-treatment change in the magnitude of change in PTSD symptoms (as measured by the PCL-5) during Alpha-Stim® treatment using paired t-tests can be used to determine sample size and power calculations for future studies.
arm group label: Use of Alpha Stim
arm group type: Experimental
description: Use of Alpha Stim Device
intervention type: Device
intervention name: Alpha Stim
description: Use of Alpha Stim Device
arm group label: Use of Alpha Stim
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: James K Rustad, MD
role: Principal Investigator
affiliation: White River Junction Veterans Affairs Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: White River Junction Veterans Affairs Medical Center
investigator full name: James Rustad
investigator title: Principal Investigator
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No