<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/NCT02204969</url>
  </required_header>
  <id_info>
    <org_study_id>822429989</org_study_id>
    <nct_id>NCT02204969</nct_id>
  </id_info>
  <brief_title>LIWA for Treatment of Alzheimer Patients</brief_title>
  <acronym>LIWA</acronym>
  <official_title>Transcranial Magnetic Stimulation (TMS) and Lithium Water for Treatment of Alzheimer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>American Society Of Thermalism And Climatology Inc</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>American Society Of Thermalism And Climatology Inc</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The thermal therapy combined with magnetic fields and ozone has a direct effect on patients&#xD;
      with dementia and Alzheimer's with a regression of more than 60% of them&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Alzheimer's disease (AD) is the leading cause of dementia and cognitive deteriorating in the&#xD;
      advanced age. This main target of this study is to determine the safety and efficacy of&#xD;
      transcranial magnetic stimulation (TMS) using novel coil design (H2) for stimulation of deep&#xD;
      brain structures concomitantly with regular treatment in Alzheimer's disease (AD) patients.&#xD;
      TMS acts by generating magnetic fields in the brain which simulate neuro-chemical changes and&#xD;
      stimulate neuronal activity translating into increased secretion of growth factors such as&#xD;
      brain derived neurotropic factor (BDNF). Hence it is postulated that TMS will have a positive&#xD;
      effect on the cognitive and behavioral symptoms of patients with AD and may ameliorated the&#xD;
      progression of the disease. The treatment is non-invasive, with no significant side effects,&#xD;
      and no need of hospitalization or anesthesia. The trial is phase II double blind study&#xD;
      including 100 AD patients ages between 50 to 80 with mild or moderate AD (Mini Mental State&#xD;
      Examination [MMSE] 16 to 26) divided into 3 groups. All participants will receive standard&#xD;
      medical therapy for AD. In addition, patients recruited for the study will receive 16&#xD;
      sessions of TMS with the H2 coil over 8 weeks. The first group will receive excitatory&#xD;
      stimulation of 10 Hz over the prefrontal and parietal cortex, the second group will receive&#xD;
      inhibitory stimulation of 1 Hz over similar brain areas and control patients will receive the&#xD;
      same amount of Sham sessions. Patient will receive 3 treatments per week in the first 3 weeks&#xD;
      and then 1 treatment per week for additional 4 weeks. Patients will be evaluated before the&#xD;
      treatments, after 8 weeks of treatment and after another 8 weeks without treatment. The&#xD;
      evaluations will include cognitive function according to ADAS-COG and MMSE, Activity of daily&#xD;
      living (ADL) functions according to ADSC-ADL, behavioral function according to the&#xD;
      Neuropsychiatric Inventory (NPI), depression according to the Cornell Scale for Depression in&#xD;
      Dementia (CSDD), care giver satisfaction according to the RUD LITE scale and computerized&#xD;
      cognitive evaluation according to the NEXING battery. We expect that the cognitive,&#xD;
      behavioral and ADL functions will improve better in the study group as compared to the Sham&#xD;
      treated group. From previous trial of TMS in neurological patients, although not in AD, we&#xD;
      anticipate that adverse events rate will be similar between groups proving the safety of deep&#xD;
      TMS treatment in patients with AD. In case our hypothesis will be proven, deep TMS treatment&#xD;
      will be added as an important modality to the conventional therapy of AD patients.&#xD;
&#xD;
      All patients will be received 500 mcg/d of lithium as supplement nutritional in form spring&#xD;
      mineral water&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2015</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">June 2015</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cognitive functioning score by ADAS-COG</measure>
    <time_frame>4 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>Transcranial magnetic stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>All participants will receive standard medical therapy for AD. In addition, patients recruited for the study will receive 16 sessions of TMS with the H2 coil over 8 weeks. The first group will receive excitatory stimulation of 10 Hz over the prefrontal and parietal cortex, the second group will receive inhibitory stimulation of 1 Hz over similar brain areas and control patients will receive the same amount of Sham sessions. Patient will receive 3 treatments per week in the first 3 weeks and then 1 treatment per week for additional 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>lithia water</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Experimental: Lithia spring water Lithia water (active) for 4 weeks then placebo water for 4 weeks Intervention: Dietary Supplement: Lithia water&#xD;
Placebo Comparator: Natural spring water Placebo water for 4 weeks then lithia water (active) for 4 weeks Intervention: Dietary Supplement: Natural spring water with negligible lithium levels</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lithia water</intervention_name>
    <description>Experimental: Lithia spring water Lithia water (active) for 4 weeks then placebo water for 4 weeks Intervention: Dietary Supplement: Lithia water&#xD;
Placebo Comparator: Natural spring water Placebo water for 4 weeks then lithia water (active) for 4 weeks Intervention: Dietary Supplement: Natural spring water with negligible lithium levels</description>
    <arm_group_label>lithia water</arm_group_label>
    <other_name>pring Mineral water</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial Magnetic stimulation</intervention_name>
    <description>All participants will receive standard medical therapy for AD. In addition, patients recruited for the study will receive 16 sessions of TMS with the H2 coil over 8 weeks. The first group will receive excitatory stimulation of 10 Hz over the prefrontal and parietal cortex, the second group will receive inhibitory stimulation of 1 Hz over similar brain areas and control patients will receive the same amount of Sham sessions. Patient will receive 3 treatments per week in the first 3 weeks and then 1 treatment per week for additional 4 weeks.</description>
    <arm_group_label>Transcranial magnetic stimulation</arm_group_label>
    <other_name>novel coil design (H2)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and women aged 50-85.&#xD;
&#xD;
          2. Diagnosed with Alzheimer's disease for at least half a year (by the DSM-IV criteria).&#xD;
&#xD;
          3. Scored 16-26 on the MMSE.&#xD;
&#xD;
          4. Received drug therapy for their disease, with each treatment having been administered&#xD;
             at an acceptable dosage for at least 5 weeks.&#xD;
&#xD;
          5. Existence of a routine therapist for changes or adverse effects reports.&#xD;
&#xD;
          6. Existence of Alzheimer diagnosis by CT or MRI tests.&#xD;
&#xD;
          7. Answered in the negative to all questions in the pre-TMS treatment safety&#xD;
             questionnaire.&#xD;
&#xD;
          8. Gave their oral and written consent to participate in the trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. An additional neurological disorder.&#xD;
&#xD;
          2. Severe psychiatric disorder.&#xD;
&#xD;
          3. Uncontrolled hypertension, beyond 170/110.&#xD;
&#xD;
          4. History of epilepsy, seizure, or heat convulsion or History of epilepsy or seizure in&#xD;
             first degree relatives.&#xD;
&#xD;
          5. History of head injury or stroke.&#xD;
&#xD;
          6. History of metal implants in the head (except dental fillings)or History of surgery&#xD;
             entailing metallic implants or known history of any metallic particles in the eye,&#xD;
             implanted cardiac pacemaker, cochlear implants, use of neuro stimulators, or any&#xD;
             medical pumps.&#xD;
&#xD;
          7. History of migraines in the last six months.&#xD;
&#xD;
          8. History of drug or alcohol abuse.&#xD;
&#xD;
          9. Inadequate communication with examiner.&#xD;
&#xD;
         10. Participation in another clinical study, either concurrent with this trial or in the 3&#xD;
             months preceding it.&#xD;
&#xD;
         11. Inability to sign a consent form.&#xD;
&#xD;
         12. Leukemia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Garis Silega, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>American Society of Thermalism and Climatology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gaviota Clinic</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Garis Silega, Dr</last_name>
      <phone>862-229-4766</phone>
      <email>drsilega@aol.com</email>
    </contact>
    <investigator>
      <last_name>Garis Silega, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>January 5, 2015</last_update_submitted>
  <last_update_submitted_qc>January 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2015</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>Alzheimer Disease</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/NCT02204969
org study id: 822429989
nct id: NCT02204969
lead sponsor: 
has dmc: Yes
The thermal therapy combined with magnetic fields and ozone has a direct effect on patients
      with dementia and Alzheimer's with a regression of more than 60% of them
Alzheimer's disease (AD) is the leading cause of dementia and cognitive deteriorating in the
      advanced age. This main target of this study is to determine the safety and efficacy of
      transcranial magnetic stimulation (TMS) using novel coil design (H2) for stimulation of deep
      brain structures concomitantly with regular treatment in Alzheimer's disease (AD) patients.
      TMS acts by generating magnetic fields in the brain which simulate neuro-chemical changes and
      stimulate neuronal activity translating into increased secretion of growth factors such as
      brain derived neurotropic factor (BDNF). Hence it is postulated that TMS will have a positive
      effect on the cognitive and behavioral symptoms of patients with AD and may ameliorated the
      progression of the disease. The treatment is non-invasive, with no significant side effects,
      and no need of hospitalization or anesthesia. The trial is phase II double blind study
      including 100 AD patients ages between 50 to 80 with mild or moderate AD (Mini Mental State
      Examination [MMSE] 16 to 26) divided into 3 groups. All participants will receive standard
      medical therapy for AD. In addition, patients recruited for the study will receive 16
      sessions of TMS with the H2 coil over 8 weeks. The first group will receive excitatory
      stimulation of 10 Hz over the prefrontal and parietal cortex, the second group will receive
      inhibitory stimulation of 1 Hz over similar brain areas and control patients will receive the
      same amount of Sham sessions. Patient will receive 3 treatments per week in the first 3 weeks
      and then 1 treatment per week for additional 4 weeks. Patients will be evaluated before the
      treatments, after 8 weeks of treatment and after another 8 weeks without treatment. The
      evaluations will include cognitive function according to ADAS-COG and MMSE, Activity of daily
      living (ADL) functions according to ADSC-ADL, behavioral function according to the
      Neuropsychiatric Inventory (NPI), depression according to the Cornell Scale for Depression in
      Dementia (CSDD), care giver satisfaction according to the RUD LITE scale and computerized
      cognitive evaluation according to the NEXING battery. We expect that the cognitive,
      behavioral and ADL functions will improve better in the study group as compared to the Sham
      treated group. From previous trial of TMS in neurological patients, although not in AD, we
      anticipate that adverse events rate will be similar between groups proving the safety of deep
      TMS treatment in patients with AD. In case our hypothesis will be proven, deep TMS treatment
      will be added as an important modality to the conventional therapy of AD patients.

      All patients will be received 500 mcg/d of lithium as supplement nutritional in form spring
      mineral water
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Cognitive functioning score by ADAS-COG
time frame: 4 months
arm group label: Transcranial magnetic stimulation
arm group type: Sham Comparator
description: All participants will receive standard medical therapy for AD. In addition, patients recruited for the study will receive 16 sessions of TMS with the H2 coil over 8 weeks. The first group will receive excitatory stimulation of 10 Hz over the prefrontal and parietal cortex, the second group will receive inhibitory stimulation of 1 Hz over similar brain areas and control patients will receive the same amount of Sham sessions. Patient will receive 3 treatments per week in the first 3 weeks and then 1 treatment per week for additional 4 weeks.
arm group label: lithia water
arm group type: Placebo Comparator
description: Experimental: Lithia spring water Lithia water (active) for 4 weeks then placebo water for 4 weeks Intervention: Dietary Supplement: Lithia water
Placebo Comparator: Natural spring water Placebo water for 4 weeks then lithia water (active) for 4 weeks Intervention: Dietary Supplement: Natural spring water with negligible lithium levels
intervention type: Dietary Supplement
intervention name: Lithia water
description: Experimental: Lithia spring water Lithia water (active) for 4 weeks then placebo water for 4 weeks Intervention: Dietary Supplement: Lithia water
Placebo Comparator: Natural spring water Placebo water for 4 weeks then lithia water (active) for 4 weeks Intervention: Dietary Supplement: Natural spring water with negligible lithium levels
arm group label: lithia water
other name: pring Mineral water
intervention type: Device
intervention name: Transcranial Magnetic stimulation
description: All participants will receive standard medical therapy for AD. In addition, patients recruited for the study will receive 16 sessions of TMS with the H2 coil over 8 weeks. The first group will receive excitatory stimulation of 10 Hz over the prefrontal and parietal cortex, the second group will receive inhibitory stimulation of 1 Hz over similar brain areas and control patients will receive the same amount of Sham sessions. Patient will receive 3 treatments per week in the first 3 weeks and then 1 treatment per week for additional 4 weeks.
arm group label: Transcranial magnetic stimulation
other name: novel coil design (H2)
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: No
last name: Garis Silega, Dr
role: Principal Investigator
affiliation: American Society of Thermalism and Climatology
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Alzheimer Disease