<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/NCT02196025</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201400335</org_study_id>
    <nct_id>NCT02196025</nct_id>
  </id_info>
  <brief_title>Transcranial Magnetic Stimulation for Treatment of Insomnia</brief_title>
  <acronym>TMSI</acronym>
  <official_title>An Open Label Trial of Sequential Bifrontal Low Frequency Repetitive Transcranial Magnetic Stimulation (r-TMS) in the Treatment of Primary Insomnia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation technique that&#xD;
      has been approved as a treatment of depression in patients that have not responded to a trial&#xD;
      of one antidepressant medication. The investigators hypothesize that low frequency TMS exerts&#xD;
      inhibitory effect on hyper excitable cortical state in patients with chronic insomnia and&#xD;
      therefore is therapeutic. The investigators want to compare the change in insomnia scores&#xD;
      between baseline and end of treatment in an open label trial with bifrontal low frequency TMS&#xD;
      stimulation in 20 patients with primary insomnia using daily stimulation of 3 weeks (15 week&#xD;
      days).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Insomnia is a common clinical problem that affects about 25 million people in the US.&#xD;
      Insomnia exacts health and economic consequences well beyond inadequate and non-restorative&#xD;
      sleep. It increases healthcare costs, causes or adds to medical and psychiatric&#xD;
      comorbidities, cognitive impairments, accidents, absenteeism and reduced quality of life.&#xD;
      Treatment of insomnia is difficult and usually needs a multimodal approach incorporating&#xD;
      various cognitive and behavioral approaches in addition to medication treatment. TMS and&#xD;
      other neurophysiological studies have shown presence of a diffuse cortical hyper-arousal in&#xD;
      patients with chronic insomnia. High frequency TMS (&gt;1 Hz) has been shown to be activating&#xD;
      whereas low frequency TMS (&lt;1Hz) has been shown to be inhibitory in clinical and&#xD;
      neurophysiological studies. TMS has been approved as a treatment of depression in patients&#xD;
      who have not responded to a trial of at least one antidepressant medication. The goal of this&#xD;
      study is to translate the knowledge learned from neurophysiological studies of insomnia to&#xD;
      the clinical treatment of insomnia using TMS as the primary modality.&#xD;
&#xD;
      Aim: Compare the change in insomnia scores between baseline and end of treatment with&#xD;
      bifrontal low frequency TMS stimulation in 20 patients with primary insomnia using daily&#xD;
      stimulation of 3 weeks (15 week days).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 2015</start_date>
  <completion_date type="Anticipated">August 2022</completion_date>
  <primary_completion_date type="Anticipated">August 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pittsburgh Sleep quality index ( PSQI)</measure>
    <time_frame>three weeks</time_frame>
    <description>Change in Pittsburgh sleep quality index scores at the ned of three weeks stimulation with transcranial magnetic stimulation. Minimum Score = 0 (good sleep); Maximum Score = 30 (disrupted sleep)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Insomnia severity index ( ISI)</measure>
    <time_frame>three weeks</time_frame>
    <description>Change in insomnia severity index scores at the ned of three weeks stimulation with transcranial magnetic stimulation. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Insomnia</condition>
  <arm_group>
    <arm_group_label>Transcranial magnetic stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive sequential bilateral bifrontal low frequency TMS stimulation daily on weekdays for three weeks. In addition, a Pittsburgh Sleep Quality Index (PSQI), Insomnia severity rating index, Montgomery Asberg Depression Rating Scale, and a sleep diary will be kept.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial magnetic stimulation</intervention_name>
    <description>Patients will receive sequential bilateral bifrontal low frequency TMS stimulation daily on weekdays for three weeks. In addition, a Pittsburgh Sleep Quality Index (PSQI), Insomnia severity rating index, Montgomery Asberg Depression Rating Scale, and a sleep diary will be kept.</description>
    <arm_group_label>Transcranial magnetic stimulation</arm_group_label>
    <other_name>repetitive Transcranial magnetic stimulation</other_name>
    <other_name>r-TMS</other_name>
    <other_name>TMS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients referred for evaluation and management of insomnia to our sleep disorders&#xD;
             clinic will be offered enrollment in this study&#xD;
&#xD;
          2. Patients must meet DSM IV criteria for Primary insomnia&#xD;
&#xD;
          3. Aged 21-65 years to target relatively healthy adults&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with co-morbid depression&#xD;
&#xD;
          2. Substance abuse in last two weeks&#xD;
&#xD;
          3. No Psychotropic medication changes 2 weeks before start of TMS treatment and no&#xD;
             changes during the 3 week treatment period&#xD;
&#xD;
          4. Patients with a major medical or psychiatric disorder that may be causing or&#xD;
             contributing to insomnia: bipolar disorder, psychosis, anxiety disorders, dementia,&#xD;
             seizure disorder and chronic pain&#xD;
&#xD;
          5. Patients with ferromagnetic material in their head or within 30 cm of the coil will be&#xD;
             excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Holbert, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UF @ Shands</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>September 2, 2021</last_update_submitted>
  <last_update_submitted_qc>September 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Insomnia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT02196025
org study id: IRB201400335
nct id: NCT02196025
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation technique that
      has been approved as a treatment of depression in patients that have not responded to a trial
      of one antidepressant medication. The investigators hypothesize that low frequency TMS exerts
      inhibitory effect on hyper excitable cortical state in patients with chronic insomnia and
      therefore is therapeutic. The investigators want to compare the change in insomnia scores
      between baseline and end of treatment in an open label trial with bifrontal low frequency TMS
      stimulation in 20 patients with primary insomnia using daily stimulation of 3 weeks (15 week
      days).
Insomnia is a common clinical problem that affects about 25 million people in the US.
      Insomnia exacts health and economic consequences well beyond inadequate and non-restorative
      sleep. It increases healthcare costs, causes or adds to medical and psychiatric
      comorbidities, cognitive impairments, accidents, absenteeism and reduced quality of life.
      Treatment of insomnia is difficult and usually needs a multimodal approach incorporating
      various cognitive and behavioral approaches in addition to medication treatment. TMS and
      other neurophysiological studies have shown presence of a diffuse cortical hyper-arousal in
      patients with chronic insomnia. High frequency TMS (>1 Hz) has been shown to be activating
      whereas low frequency TMS (<1Hz) has been shown to be inhibitory in clinical and
      neurophysiological studies. TMS has been approved as a treatment of depression in patients
      who have not responded to a trial of at least one antidepressant medication. The goal of this
      study is to translate the knowledge learned from neurophysiological studies of insomnia to
      the clinical treatment of insomnia using TMS as the primary modality.

      Aim: Compare the change in insomnia scores between baseline and end of treatment with
      bifrontal low frequency TMS stimulation in 20 patients with primary insomnia using daily
      stimulation of 3 weeks (15 week days).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pittsburgh Sleep quality index ( PSQI)
time frame: three weeks
description: Change in Pittsburgh sleep quality index scores at the ned of three weeks stimulation with transcranial magnetic stimulation. Minimum Score = 0 (good sleep); Maximum Score = 30 (disrupted sleep)
measure: Insomnia severity index ( ISI)
time frame: three weeks
description: Change in insomnia severity index scores at the ned of three weeks stimulation with transcranial magnetic stimulation. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
arm group label: Transcranial magnetic stimulation
arm group type: Experimental
description: Patients will receive sequential bilateral bifrontal low frequency TMS stimulation daily on weekdays for three weeks. In addition, a Pittsburgh Sleep Quality Index (PSQI), Insomnia severity rating index, Montgomery Asberg Depression Rating Scale, and a sleep diary will be kept.
intervention type: Device
intervention name: Transcranial magnetic stimulation
description: Patients will receive sequential bilateral bifrontal low frequency TMS stimulation daily on weekdays for three weeks. In addition, a Pittsburgh Sleep Quality Index (PSQI), Insomnia severity rating index, Montgomery Asberg Depression Rating Scale, and a sleep diary will be kept.
arm group label: Transcranial magnetic stimulation
other name: repetitive Transcranial magnetic stimulation
other name: r-TMS
other name: TMS
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: No
last name: Richard Holbert, MD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Sleep Initiation and Maintenance Disorders