<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/NCT03298308</url>
  </required_header>
  <id_info>
    <org_study_id>418467-1</org_study_id>
    <nct_id>NCT03298308</nct_id>
  </id_info>
  <brief_title>Brainwave Changes and Cranial Electrotherapy Stimulation</brief_title>
  <official_title>Effects of Cranial Electric Stimulation on Brain Wave Activity: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Walter Reed National Military Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Walter Reed National Military Medical Center</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>
      This pilot study explored relationships between cranial electric stimulation and brainwave&#xD;
      changes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This pilot study will collect data from properly consented and subsequently enrolled subjects&#xD;
      in the Psychiatric Continuity Service (PCS). All PCS programs provide both group and&#xD;
      individual therapy designed to address various chronic mental health disorders such as major&#xD;
      depressive disorder, anxiety, and post-traumatic stress disorder (PTSD). Group therapy and&#xD;
      education focus on how chronic mental health disorders develop, the recovery process and&#xD;
      psychosocial stressors that may contribute to both improvement in functioning and declines.&#xD;
      Every patient is different with regard to how his or her program is tailored, but everyone&#xD;
      receives weekly individual counseling from behavioral health providers (psychiatrists,&#xD;
      psychologists and clinical social workers). PCS works in tandem with other treatment&#xD;
      providers, case managers and chains of command. PCS is also equipped to transfer patients in&#xD;
      need to higher levels of care in cases of emergency.&#xD;
&#xD;
      All prospective subjects will be active duty service members who are enrolled in PCS.&#xD;
      Subjects will be recruited by the Associate Investigator (AI) or Principal Investigator (PI).&#xD;
      The primary outcome measure is the exploration of changes in specific brain wave activity in&#xD;
      response to a Cranial Electrotherapy Stimulation (CES) intervention.&#xD;
&#xD;
      Subjects who agree to participate in the study will complete a consent and Health Insurance&#xD;
      Portability and Accountability Act (HIPAA) form and baseline questionnaires. In addition,&#xD;
      since the fetal effects of the CES device is not known;, female subjects will have to present&#xD;
      a negative pregnancy test within one week of the research intervention. Those female subjects&#xD;
      to which pregnancy is unlikely (i.e. hysterectomy), will be excluded from a pregnancy test if&#xD;
      this information can be verified medically. will self-report regarding as it applies&#xD;
      menstrual cycle length and birth control method used within the last two weeks.&#xD;
&#xD;
      The intervention will take place during clinic hours. This will be a one-time intervention&#xD;
      that will last approximately 1 to 1 ½ hours. The AI will prepare the CES device, briefly&#xD;
      explain the function, and place the CES ear clips on the subject. The CES device will not be&#xD;
      turned on at this point. This is similar to clinic practice, however in clinical practice any&#xD;
      PCS staff trained in the use of the CES device may prepare and administer the CES device to&#xD;
      the patient.&#xD;
&#xD;
      Next the AI will prepare the MindSet EEG device, ensure that it is functioning properly, and&#xD;
      obtain signal acquisition. The AI will then explain the brainwave headset (MindSet) to the&#xD;
      subject and properly place the headset on their head. Next a series of computer led&#xD;
      activities to reduce extraneous artifacts (such as eye blink and muscle movement) will be&#xD;
      completed by the subject. Following this, a baseline test measuring brainwave frequencies&#xD;
      will be completed by the subject. This will last 30 seconds. Once this is completed, the CES&#xD;
      device can be turned on and activated for 20 minutes. The CES micro amperage will be set by&#xD;
      the subject based on therapeutic dose and locked in place on the CES device. Immediately&#xD;
      following the completion of the 20 minute CES session, an EEG brainwave measure will be&#xD;
      completed. Additional brainwave measure will be taken 5 minutes and 10 minutes post the CES&#xD;
      session. Each of these brainwave measures will last 30 seconds.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 27, 2016</start_date>
  <completion_date type="Actual">May 10, 2017</completion_date>
  <primary_completion_date type="Actual">May 10, 2017</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quantitative EEG Analysis</measure>
    <time_frame>Quantitative EEG collected at baseline (immediately before stimulation), immediately after 20 minutes of stimulation and then 5 and 10 minutes post stimualtion. Each of these four measures will record 30 seconds of brainwave activity</time_frame>
    <description>The investigators used a commercially available EEG headset (Neurosky MindSet) in combination with EEG software (SmartMind) to obtain and analyze the Quantitative EEG from the subjects. The combination of the EEG headset with the software identified the five brainwave frequencies that are clinically relevant in studying EEG activity: Alpha, Beta, Delta, Gamma, and Theta. The combination of the headset and software reported changes in brainwave amplitude in microvolts for each brainwave frequency. Alpha waves increase with relaxation and drowsiness; and Beta waves, increase with wakefulness and concentration. Delta and Theta waves increase during meditative states and Gamma may suggest brain synchronicity.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Psychiatric Disorder</condition>
  <arm_group>
    <arm_group_label>Brainwave</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Brainwave analysis after cranial electric stimulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cranial Electric Stimulation</intervention_name>
    <description>Micro amperage TCDS</description>
    <arm_group_label>Brainwave</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion Criteria All prospective subjects will be active duty service members who&#xD;
             are enrolled in PCS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Subjects will be excluded who have a seizure disorder, a cardiac pacemaker, or&#xD;
             active untreated vertigo.&#xD;
&#xD;
               -  Subjects will be excluded if they have used CES the day of the study. However,&#xD;
                  they may participate in the study the following day.&#xD;
&#xD;
               -  Female subjects who are or who suspect they may be pregnant.&#xD;
&#xD;
               -  Subjects will also be excluded who are clinically judged by the investigators to&#xD;
                  be actively suicidal or have another psychiatric condition that would require&#xD;
                  inpatient hospitalization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>September 26, 2017</last_update_submitted>
  <last_update_submitted_qc>September 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Problem Behavior</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/NCT03298308
org study id: 418467-1
nct id: NCT03298308
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This pilot study explored relationships between cranial electric stimulation and brainwave
      changes.
This pilot study will collect data from properly consented and subsequently enrolled subjects
      in the Psychiatric Continuity Service (PCS). All PCS programs provide both group and
      individual therapy designed to address various chronic mental health disorders such as major
      depressive disorder, anxiety, and post-traumatic stress disorder (PTSD). Group therapy and
      education focus on how chronic mental health disorders develop, the recovery process and
      psychosocial stressors that may contribute to both improvement in functioning and declines.
      Every patient is different with regard to how his or her program is tailored, but everyone
      receives weekly individual counseling from behavioral health providers (psychiatrists,
      psychologists and clinical social workers). PCS works in tandem with other treatment
      providers, case managers and chains of command. PCS is also equipped to transfer patients in
      need to higher levels of care in cases of emergency.

      All prospective subjects will be active duty service members who are enrolled in PCS.
      Subjects will be recruited by the Associate Investigator (AI) or Principal Investigator (PI).
      The primary outcome measure is the exploration of changes in specific brain wave activity in
      response to a Cranial Electrotherapy Stimulation (CES) intervention.

      Subjects who agree to participate in the study will complete a consent and Health Insurance
      Portability and Accountability Act (HIPAA) form and baseline questionnaires. In addition,
      since the fetal effects of the CES device is not known;, female subjects will have to present
      a negative pregnancy test within one week of the research intervention. Those female subjects
      to which pregnancy is unlikely (i.e. hysterectomy), will be excluded from a pregnancy test if
      this information can be verified medically. will self-report regarding as it applies
      menstrual cycle length and birth control method used within the last two weeks.

      The intervention will take place during clinic hours. This will be a one-time intervention
      that will last approximately 1 to 1 ½ hours. The AI will prepare the CES device, briefly
      explain the function, and place the CES ear clips on the subject. The CES device will not be
      turned on at this point. This is similar to clinic practice, however in clinical practice any
      PCS staff trained in the use of the CES device may prepare and administer the CES device to
      the patient.

      Next the AI will prepare the MindSet EEG device, ensure that it is functioning properly, and
      obtain signal acquisition. The AI will then explain the brainwave headset (MindSet) to the
      subject and properly place the headset on their head. Next a series of computer led
      activities to reduce extraneous artifacts (such as eye blink and muscle movement) will be
      completed by the subject. Following this, a baseline test measuring brainwave frequencies
      will be completed by the subject. This will last 30 seconds. Once this is completed, the CES
      device can be turned on and activated for 20 minutes. The CES micro amperage will be set by
      the subject based on therapeutic dose and locked in place on the CES device. Immediately
      following the completion of the 20 minute CES session, an EEG brainwave measure will be
      completed. Additional brainwave measure will be taken 5 minutes and 10 minutes post the CES
      session. Each of these brainwave measures will last 30 seconds.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Quantitative EEG Analysis
time frame: Quantitative EEG collected at baseline (immediately before stimulation), immediately after 20 minutes of stimulation and then 5 and 10 minutes post stimualtion. Each of these four measures will record 30 seconds of brainwave activity
description: The investigators used a commercially available EEG headset (Neurosky MindSet) in combination with EEG software (SmartMind) to obtain and analyze the Quantitative EEG from the subjects. The combination of the EEG headset with the software identified the five brainwave frequencies that are clinically relevant in studying EEG activity: Alpha, Beta, Delta, Gamma, and Theta. The combination of the headset and software reported changes in brainwave amplitude in microvolts for each brainwave frequency. Alpha waves increase with relaxation and drowsiness; and Beta waves, increase with wakefulness and concentration. Delta and Theta waves increase during meditative states and Gamma may suggest brain synchronicity.
arm group label: Brainwave
arm group type: Experimental
description: Brainwave analysis after cranial electric stimulation
intervention type: Device
intervention name: Cranial Electric Stimulation
description: Micro amperage TCDS
arm group label: Brainwave
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Mental Disorders
mesh term: Problem Behavior
sharing ipd: No