xml: <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/NCT06005103</url>
    </required_header>
    <id_info>
      <org_study_id>2215332</org_study_id>
      <nct_id>NCT06005103</nct_id>
    </id_info>
    <brief_title>T-PEMF Headband Stimulation for Patients With Moderate to Servere Depression</brief_title>
    <official_title>An 8-week Randomized Trial Comparing Treatment With an Active or Sham T-PEMF Headband Stimulation for Patients With Moderate to Servere Depression</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mental Health Services in the Capital Region, Denmark</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Innovation Fund Denmark</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Mental Health Services in the Capital Region, Denmark</source>
    <oversight_info>
      <has_dmc>Yes</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 study is a blinded 8-week, randomized trial conducted to clarify whether treatment with&#xD;
        brain stimulation for half an hour daily for eight weeks with a headband with weak pulsating&#xD;
        electromagnetic fields (T-PEMF) can achieve a safe effect on depression compared to the same&#xD;
        treatment with a placebo T-PEMF.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will take place at Psychiatric Center Copenhagen. The purpose of this study is to&#xD;
        clarify whether daily treatment over eight weeks with weak pulsating electromagnetic fields&#xD;
        (T-PEMF) can achieve a safe effect on depression compared to the same treatment with a&#xD;
        placebo T-PEMF. Previous Danish studies have shown a significant effect in the treatment of&#xD;
        patients with treatment-resistant depression. There are no studies, neither in Denmark nor in&#xD;
        the world, which demonstrate an effect on the early stages in the development of depressive&#xD;
        disorders.&#xD;
  &#xD;
        The study is designed as a blinded, randomized study where active treatment is compared with&#xD;
        inactive (sham) treatment. At the same time, possible side effects in the use of the headband&#xD;
        (MoodHeadBand, MHB) are investigated.&#xD;
  &#xD;
        The project starts in May 2023. The aim is for 80 patients to be included in the study.&#xD;
  &#xD;
        Patients consecutively referred are asked after an initial interview whether they wish to&#xD;
        participate in the study. If they give informed consent to this, they will be randomized to&#xD;
        active or sham treatment. The treatment itself takes place at home, 30 minutes once a day,&#xD;
        for 8 weeks. &quot;Treatment as usual&quot; takes place in parallel to the study treatment, and&#xD;
        consists of psychotherapy in the form of Cognitive Behavioral Therapy (CBT) in a group or&#xD;
        individually and antidepressive medications.&#xD;
  &#xD;
        At the start, the clinical diagnosis is obtained and validated with a structured interview,&#xD;
        to ensure that the diagnostic criteria for the diagnosis are present and that the exclusion&#xD;
        criteria are not present. The degree of depression is examined with Hamilton's Depression&#xD;
        Scale (HAM-D17), and Inventory of Depressive Symptomatology (IDS-SR). Quality of life (WHO-5)&#xD;
        and degree of side effects (UKU-24) are included.&#xD;
  &#xD;
        Changes in the level of depression and side effects are measured by the Quick Inventory of&#xD;
        Depressive Symptomatology (QIDS16-SR) every week after the start of treatment The degree of&#xD;
        any side effects is measured at baseline and weeks 1, 2, 4, 6, and 8 by UKU-24.&#xD;
  &#xD;
        At the end of the treatment, the degree of depression is examined again using the HAM-D17,&#xD;
        IDS-SR, and quality of life (WHO-5). The degree of satisfaction with the use of MHB is&#xD;
        examined on a scale from 1-7.&#xD;
  &#xD;
        No significant side effects have been registered when using the same type of magnetic field&#xD;
        treatment in the previous Danish studies. It has also been shown that it is possible to carry&#xD;
        out the treatment at home without significant problems.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 6, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</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 will receive either active (A) or sham (B) treatment with the T-PEMF technology using af headband designed for this. The headbands will be chosen randomly from a bag containing a mix of headbands applying either treatment A or B. The firm MoodHeadBand Aps was in control of the randomization procedure, making sure that each bag contained the same amount of headbands applying treatment A and B.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Neither patients nor the research team knows which headbands apply treatment A or B. The firm MoodHeadBand Aps was in charge of the randomization procedure. The headbands, control boxes and powerbanks are identifical. No difference can be seen or felt when the headbands are plugged into the control boxes and powerbanks. A small bulb will be lit when the controlbox is connected to a charged powerbank.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Inventory of Depressive Symptomatology (Self-Report) (IDS-SR)</measure>
      <time_frame>8 weeks</time_frame>
      <description>The IDS-SR is a 30-item self-report scale for measuring depressive symptoms, with satisfying psychometric features and good correlations with Hamilton-D17 (HAM-D17). IDS will be conducted assisted by a clinician at baseline and at the endpoint. Patients will receive a Quick-IDS via email on a weekly basis for self-report.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hamilton-D17 (HAM-D17)</measure>
      <time_frame>8 weeks</time_frame>
      <description>A scale measuring depressive symptoms. Will be applied at baseline and at the end point</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hamilton-D6 (HAM-D6)</measure>
      <time_frame>8 weeks</time_frame>
      <description>A scale measuring depressive symptoms. Will be applied at baseline and at the end point.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>WHO-5</measure>
      <time_frame>8 weeks</time_frame>
      <description>This Well-Being Index consists of five items that are scored on a frequency response scale from &quot;none of the time&quot; (0) to &quot;all of the time&quot; (5).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Udvalget for Kliniske Undersøgelser scale (UKU-24)</measure>
      <time_frame>8 weeks</time_frame>
      <description>Side effects are assessed by the UKU-24 scale, including free text comments. Side effects will be assesed at week 1, 2, 4, 6 and at the end point.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Moderate Depression</condition>
    <condition>Severe Depressive Episode Without Psychotic Symptoms</condition>
    <condition>Recurrent Depressive Disorder, Current Episode Moderate</condition>
    <condition>Recurrent Depressive Disorder, Current Episode Severe Without Psychotic Symptoms</condition>
    <arm_group>
      <arm_group_label>Active treatment with T-PEMF (Active)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The patients will receive treatment with T-PEMF using a headband containing 20 coils placed symmetrically around the head of the patient. The device delivers 55 Hz magnetic field. Duration of treatment is 30 minutes once a day for 8 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Inactive treatment with T-PEMF (sham)</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Patients will use an identical device, which does not deliver T-PEMF treatment. The patients will use the headband as the active group for 30 minutes, once a day, for 8 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Transcranial Pulsed Electromagnetic Fields (T-PEMF) delivered via a headband</intervention_name>
      <description>The headband will deliver a 55 Hz electromagnetic field, when plugged into a charged powerbank, if the device is programmed to deliver an active treatment.</description>
      <arm_group_label>Active treatment with T-PEMF (Active)</arm_group_label>
      <other_name>T-PEMF delivered via MoodHeadBand (MHB)</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>No treatment delivered via headband</intervention_name>
      <description>The headband will be inactive and not deliver an electromagnetic field when plugged into a charged powerbank. The bulb on the control box will still be lit, when plugged to a powerbank.</description>
      <arm_group_label>Inactive treatment with T-PEMF (sham)</arm_group_label>
      <other_name>No treatment delivered via MoodHeadBand (MHB)</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Meeting the diagnostic criteria for moderate to severe depressive episode without&#xD;
               psychotic symptoms according to the International Classification of Diseases and&#xD;
               Related Health Problems 10th Revision (ICD-10)(The ICD-10 Classification of Mental and&#xD;
               Behavioural Disorders: Diagnostic Criteria for Research 1993).&#xD;
  &#xD;
            -  Female participants: Females in the fertile age must deliver a negative pregnancy&#xD;
               test, or previously have been sterilized.&#xD;
  &#xD;
            -  Female fertile participants: They must use safe contraceptive methods to be included&#xD;
               in the study, and during the whole study.&#xD;
  &#xD;
            -  Has given written, informed consent to the trial.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inability to speak or understand the Danish language.&#xD;
  &#xD;
            -  A current high risk of suicide (a score of 2 or more on the HAM-D-17 item 3).&#xD;
  &#xD;
            -  A co-morbid substance dependence.&#xD;
  &#xD;
            -  Bipolar affective disorder.&#xD;
  &#xD;
            -  Psychotic illness.&#xD;
  &#xD;
            -  Dementia.&#xD;
  &#xD;
            -  Other diagnoses of organic brain disease.&#xD;
  &#xD;
            -  The participant has any kind of implant, e.g. pacemakers or cochlear implants.&#xD;
  &#xD;
            -  Female participants: Pregnancy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Martin B. Jørgensen, MD MSc</last_name>
      <role>Principal Investigator</role>
      <affiliation>Psychiatric Center Copenhagen</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Martin B. Jørgensen, MD DMSc</last_name>
      <phone>23328669</phone>
      <phone_ext>+45</phone_ext>
      <email>Martin.Balslev.Joergensen@regionh.dk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ulrik H. Haahr, MD</last_name>
      <phone>53765787</phone>
      <phone_ext>+45</phone_ext>
      <email>ulrik.helt.haahr@regionh.dk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Psychiatric Center Copenhagen</name>
        <address>
          <city>Frederiksberg</city>
          <state>Capital Region</state>
          <zip>2600</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nana B. Sørensen, MD</last_name>
        <phone>23 26 70 81</phone>
        <phone_ext>+45</phone_ext>
        <email>nana.brandborg.soerensen@regionh.dk</email>
      </contact>
      <investigator>
        <last_name>Nana Brandborg B. Sørensen, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Randomized Controlled Trial</keyword>
    <keyword>Depression</keyword>
    <keyword>Transcranial Pulsed Electro-Magnetic Fields (T-PEMF)</keyword>
    <keyword>Psychiatry</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Recurrence</mesh_term>
      <mesh_term>Depression</mesh_term>
      <mesh_term>Depressive Disorder</mesh_term>
      <mesh_term>Mental Disorders</mesh_term>
      <mesh_term>Psychotic Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>It is not possible to share individual participant data due to GDPR. Anonymised data after publishing might be available per request.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06005103
  org study id: 2215332
  nct id: NCT06005103
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study is a blinded 8-week, randomized trial conducted to clarify whether treatment with
        brain stimulation for half an hour daily for eight weeks with a headband with weak pulsating
        electromagnetic fields (T-PEMF) can achieve a safe effect on depression compared to the same
        treatment with a placebo T-PEMF.
  The study will take place at Psychiatric Center Copenhagen. The purpose of this study is to
        clarify whether daily treatment over eight weeks with weak pulsating electromagnetic fields
        (T-PEMF) can achieve a safe effect on depression compared to the same treatment with a
        placebo T-PEMF. Previous Danish studies have shown a significant effect in the treatment of
        patients with treatment-resistant depression. There are no studies, neither in Denmark nor in
        the world, which demonstrate an effect on the early stages in the development of depressive
        disorders.
  
        The study is designed as a blinded, randomized study where active treatment is compared with
        inactive (sham) treatment. At the same time, possible side effects in the use of the headband
        (MoodHeadBand, MHB) are investigated.
  
        The project starts in May 2023. The aim is for 80 patients to be included in the study.
  
        Patients consecutively referred are asked after an initial interview whether they wish to
        participate in the study. If they give informed consent to this, they will be randomized to
        active or sham treatment. The treatment itself takes place at home, 30 minutes once a day,
        for 8 weeks. "Treatment as usual" takes place in parallel to the study treatment, and
        consists of psychotherapy in the form of Cognitive Behavioral Therapy (CBT) in a group or
        individually and antidepressive medications.
  
        At the start, the clinical diagnosis is obtained and validated with a structured interview,
        to ensure that the diagnostic criteria for the diagnosis are present and that the exclusion
        criteria are not present. The degree of depression is examined with Hamilton's Depression
        Scale (HAM-D17), and Inventory of Depressive Symptomatology (IDS-SR). Quality of life (WHO-5)
        and degree of side effects (UKU-24) are included.
  
        Changes in the level of depression and side effects are measured by the Quick Inventory of
        Depressive Symptomatology (QIDS16-SR) every week after the start of treatment The degree of
        any side effects is measured at baseline and weeks 1, 2, 4, 6, and 8 by UKU-24.
  
        At the end of the treatment, the degree of depression is examined again using the HAM-D17,
        IDS-SR, and quality of life (WHO-5). The degree of satisfaction with the use of MHB is
        examined on a scale from 1-7.
  
        No significant side effects have been registered when using the same type of magnetic field
        treatment in the previous Danish studies. It has also been shown that it is possible to carry
        out the treatment at home without significant problems.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients will receive either active (A) or sham (B) treatment with the T-PEMF technology using af headband designed for this. The headbands will be chosen randomly from a bag containing a mix of headbands applying either treatment A or B. The firm MoodHeadBand Aps was in control of the randomization procedure, making sure that each bag contained the same amount of headbands applying treatment A and B.
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Neither patients nor the research team knows which headbands apply treatment A or B. The firm MoodHeadBand Aps was in charge of the randomization procedure. The headbands, control boxes and powerbanks are identifical. No difference can be seen or felt when the headbands are plugged into the control boxes and powerbanks. A small bulb will be lit when the controlbox is connected to a charged powerbank.
  measure: Inventory of Depressive Symptomatology (Self-Report) (IDS-SR)
  time frame: 8 weeks
  description: The IDS-SR is a 30-item self-report scale for measuring depressive symptoms, with satisfying psychometric features and good correlations with Hamilton-D17 (HAM-D17). IDS will be conducted assisted by a clinician at baseline and at the endpoint. Patients will receive a Quick-IDS via email on a weekly basis for self-report.
  measure: Hamilton-D17 (HAM-D17)
  time frame: 8 weeks
  description: A scale measuring depressive symptoms. Will be applied at baseline and at the end point
  measure: Hamilton-D6 (HAM-D6)
  time frame: 8 weeks
  description: A scale measuring depressive symptoms. Will be applied at baseline and at the end point.
  measure: WHO-5
  time frame: 8 weeks
  description: This Well-Being Index consists of five items that are scored on a frequency response scale from "none of the time" (0) to "all of the time" (5).
  measure: Udvalget for Kliniske Undersøgelser scale (UKU-24)
  time frame: 8 weeks
  description: Side effects are assessed by the UKU-24 scale, including free text comments. Side effects will be assesed at week 1, 2, 4, 6 and at the end point.
  arm group label: Active treatment with T-PEMF (Active)
  arm group type: Experimental
  description: The patients will receive treatment with T-PEMF using a headband containing 20 coils placed symmetrically around the head of the patient. The device delivers 55 Hz magnetic field. Duration of treatment is 30 minutes once a day for 8 weeks.
  arm group label: Inactive treatment with T-PEMF (sham)
  arm group type: Sham Comparator
  description: Patients will use an identical device, which does not deliver T-PEMF treatment. The patients will use the headband as the active group for 30 minutes, once a day, for 8 weeks.
  intervention type: Device
  intervention name: Transcranial Pulsed Electromagnetic Fields (T-PEMF) delivered via a headband
  description: The headband will deliver a 55 Hz electromagnetic field, when plugged into a charged powerbank, if the device is programmed to deliver an active treatment.
  arm group label: Active treatment with T-PEMF (Active)
  other name: T-PEMF delivered via MoodHeadBand (MHB)
  intervention type: Device
  intervention name: No treatment delivered via headband
  description: The headband will be inactive and not deliver an electromagnetic field when plugged into a charged powerbank. The bulb on the control box will still be lit, when plugged to a powerbank.
  arm group label: Inactive treatment with T-PEMF (sham)
  other name: No treatment delivered via MoodHeadBand (MHB)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Martin B. Jørgensen, MD MSc
  role: Principal Investigator
  affiliation: Psychiatric Center Copenhagen
  last name: Martin B. Jørgensen, MD DMSc
  phone: 23328669
  phone ext: +45
  email: Martin.Balslev.Joergensen@regionh.dk
  last name: Ulrik H. Haahr, MD
  phone: 53765787
  phone ext: +45
  email: ulrik.helt.haahr@regionh.dk
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Denmark
  responsible party type: Sponsor
  mesh term: Recurrence
  mesh term: Depression
  mesh term: Depressive Disorder
  mesh term: Mental Disorders
  mesh term: Psychotic Disorders
  sharing ipd: No
  ipd description: It is not possible to share individual participant data due to GDPR. Anonymised data after publishing might be available per request.