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/NCT06036368</url>
    </required_header>
    <id_info>
      <org_study_id>TS004-PD</org_study_id>
      <nct_id>NCT06036368</nct_id>
    </id_info>
    <brief_title>Study to Evaluate Safety and Efficacy of Peroneal Transcutaneous NeuroModulation in Subjects With Parkinson's Disease and Essential Tremor</brief_title>
    <official_title>6-weeks, Open-label, Single-Site Study to Evaluate Safety, Tolerability and Efficacy of the Home-based Peroneal Electrical Transcutaneous NeuroModulation (Peroneal eTNM®) Treatment Via Nerve Stimulator URIS ITM in Treatment of Symptoms Related to Movement Disorders in Subjects With Parkinson's Disease (PD) and Essential Tremor (ET)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Stimvia s.r.o.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Stimvia s.r.o.</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a 6-week exploratory clinical study, designed to test whether treatment with peroneal&#xD;
        electrical trans-cutaneous stimulation can have a beneficial effects on symptoms associated&#xD;
        with Parkinson's diseases and essential tremor.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a 6-week, open-label, single site clinical study designed to test whether treatment&#xD;
        with peroneal electrical trans-cutaneous stimulation (eTNM) can have a beneficial effects on&#xD;
        symptoms associated with Parkinson's diseases (PD) and essential tremor (ET). Eligible&#xD;
        patients will be treated with eTNM at home for 6 weeks. Primary endpoint in this study is&#xD;
        tolerability and safety, secondary and exploratory endpoints are various scale designed to&#xD;
        capture improvements in the most bothersome symptoms of PD or ET.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 31, 2024</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>Safety and tolerability</measure>
      <time_frame>Baseline to end of treatment at 6 weeks</time_frame>
      <description>Incidence of treatment emergent adverse events</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Efficacy</measure>
      <time_frame>Baseline to end of treatment at 6 weeks</time_frame>
      <description>Change in Patient Global Impression of Improvement scale (Scores 1-7, lower number = better)</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Exploratory efficacy</measure>
      <time_frame>Baseline to end of treatment at 6 weeks</time_frame>
      <description>The Movement Disorders Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score (both total score and subscores) (applicable only for subjects with PD)(0-260, lower score = better)</description>
    </other_outcome>
    <other_outcome>
      <measure>Exploratory efficacy</measure>
      <time_frame>Baseline to end of treatment at 6 weeks</time_frame>
      <description>Essential tremor rating assessment scale (TETRAS) score (applicable only for subjects with ET, 0-64, lower scores = better))</description>
    </other_outcome>
    <other_outcome>
      <measure>Exploratory efficacy</measure>
      <time_frame>Baseline to end of treatment at 6 weeks</time_frame>
      <description>Bradykinesis and rigidity measured by Five Times Sit to Stand Test (FTSTS) (applicable only for subjects with PD, time in seconds, lower = better))</description>
    </other_outcome>
    <other_outcome>
      <measure>Exploratory efficacy</measure>
      <time_frame>Baseline to end of treatment at 6 weeks</time_frame>
      <description>Bradykinesis and rigidity measured objectively using the 10 meter Walking Speed Test (WST) (time in seconds, lower = better)(applicable only for subjects with PD)</description>
    </other_outcome>
    <other_outcome>
      <measure>Exploratory efficacy</measure>
      <time_frame>Baseline to end of treatment at 6 weeks</time_frame>
      <description>Effect on patient's daily activities measured by Bain and Findley Activities of Daily Living (BF-ADL) (25-100, lower score = better)</description>
    </other_outcome>
    <other_outcome>
      <measure>Exploratory efficacy</measure>
      <time_frame>Baseline to end of treatment at 6 weeks</time_frame>
      <description>Degree of disability measured by modified Rankin Scale (mRS) (0-6, lower score= better)</description>
    </other_outcome>
    <other_outcome>
      <measure>Exploratory efficacy</measure>
      <time_frame>Baseline to end of treatment at 6 weeks</time_frame>
      <description>Quality of life measured by European Quality of Life-5 Dimensions questionnaire (EQ-5D-5L)(0.532-1.000, higher score = better)</description>
    </other_outcome>
    <other_outcome>
      <measure>Exploratory efficacy</measure>
      <time_frame>Baseline to end of treatment at 6 weeks</time_frame>
      <description>Disease-specific quality of life measured by Parkinson's Disease Questionnaire (PDQ -39)(0-100, lower score = better)</description>
    </other_outcome>
    <other_outcome>
      <measure>Exploratory efficacy</measure>
      <time_frame>Baseline to end of treatment at 6 weeks</time_frame>
      <description>Patient's satisfaction using Treatment Satisfaction Visual Analog scale (TS-VAS)(0-100, higher score = better)</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Parkinson's Disease</condition>
    <condition>Essential Tremor</condition>
    <arm_group>
      <arm_group_label>Peroneal eTNM arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All patients will receive treatment with peroneal eTNM</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®)</intervention_name>
      <description>This is a non-invasive intervention, which utilizes direct trancutaneous, electrical stimulation of the peroneal nerve</description>
      <arm_group_label>Peroneal eTNM arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years of age&#xD;
  &#xD;
            -  Competent and willing to provide written, informed consent to participate in the study&#xD;
  &#xD;
            -  Stable dose of any chronic medications, if applicable, for 30 days prior to study&#xD;
               entry&#xD;
  &#xD;
            -  Willing to comply with study protocol requirements&#xD;
  &#xD;
            -  Subject agrees not to participate in another study from 30 days prior the screening&#xD;
               visit until the final study visit&#xD;
  &#xD;
            -  For subjects with PD:&#xD;
  &#xD;
          Bradykinesia in &quot;on&quot; period based on clinical assessment Rigidity in &quot;on&quot; period based on&#xD;
          clinical assessment Hand/arm exhibiting tremor (resting and/or intentional and/or postural)&#xD;
          ≥ grade 1 as assessed by the MDS-UPDRS tremor score in &quot;on&quot; period&#xD;
  &#xD;
          • For subjects with ET: Visible hand/arm and/or foot/leg tremor (resting and/or intentional&#xD;
          and/or postural) ≥ grade 1 as assessed by the TETRAS&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain&#xD;
               stimulator&#xD;
  &#xD;
            -  Suspected or diagnosed epilepsy or other seizure disorder&#xD;
  &#xD;
            -  Severe degree of disability or dependence in daily activities &gt;grade 3 as measured by&#xD;
               modified Rankin Scale (mRS)&#xD;
  &#xD;
            -  Presence of clinical signs or diagnosis of dementia&#xD;
  &#xD;
            -  Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous&#xD;
               lesions of skin at stimulation site&#xD;
  &#xD;
            -  Presence of clinical signs of peripheral neuropathy on lower limbs&#xD;
  &#xD;
            -  Presence of chorea and/or dyskinesia&#xD;
  &#xD;
            -  Clinical symptoms or diagnosis of major depressive disorder&#xD;
  &#xD;
            -  Presence of any other neurodegenerative disease. These may include multisystem&#xD;
               atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's&#xD;
               disease.&#xD;
  &#xD;
            -  Botulinum toxin injection within 6 months prior to study enrollment&#xD;
  &#xD;
            -  Participation in another interventional clinical trial in the last 30 days, which may&#xD;
               confound the results of this study, unless approved by the Sponsor&#xD;
  &#xD;
            -  Subject is breastfeeding, pregnant, intends to become pregnant during the study, or of&#xD;
               childbearing potential, sexually active and not practicing a highly reliable method of&#xD;
               birth control (these are methods with a failure quotient of &lt;1% year such as hormonal&#xD;
               implants, injectable contraceptives, oral contraceptives of combination type,&#xD;
               intra-uterine pessaries restricted to hormone contraceptive coil, sexual abstinence or&#xD;
               vasectomy of the partner). The pregnancy test in urine at both Visits 1 and 2 needs to&#xD;
               be negative in women of childbearing potential.&#xD;
  &#xD;
            -  Subjects unable to communicate effectively with the investigator and staff&#xD;
  &#xD;
            -  Life expectancy less than 6 months&#xD;
  &#xD;
            -  Subject with active malignant disease&#xD;
  &#xD;
            -  Subject with alcohol (more than 100 mg ethanol per day) or drug abuse during the&#xD;
               recruitment and during the trial course&#xD;
  &#xD;
            -  Subject who, in the opinion of the physician, may interfere with optimal participation&#xD;
               in the clinical trial or may pose a risk to the subject&#xD;
  &#xD;
            -  Characteristics indicating a poor understanding of the study or characteristics that&#xD;
               indicate the subject may have poor compliance with the study protocol&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>David Skoloudik, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cerebrovaskulární poradna s.r.o., Ostrava</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Roman V Dvorak, MD PhD</last_name>
      <phone>+420 734 577 837</phone>
      <email>dvorak@stimvia.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lukas Doskocil</last_name>
      <phone>+420 776 721 127</phone>
      <email>doskocil@stimvia.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Cerebrovaskulární poradna s.r.o.</name>
        <address>
          <city>Ostrava</city>
          <zip>70200</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <contact>
        <last_name>David Skoloudik, MD, PhD</last_name>
        <phone>+420 739 782 970</phone>
        <email>skoloudik@email.cz</email>
      </contact>
    </location>
    <location_countries>
      <country>Czechia</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Parkinson's Disease (PD) and Essential Tremor (ET)</keyword>
    <keyword>Peroneal Electrical Transcutaneous NeuroModulation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Parkinson Disease</mesh_term>
      <mesh_term>Tremor</mesh_term>
      <mesh_term>Essential Tremor</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06036368
  org study id: TS004-PD
  nct id: NCT06036368
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This is a 6-week exploratory clinical study, designed to test whether treatment with peroneal
        electrical trans-cutaneous stimulation can have a beneficial effects on symptoms associated
        with Parkinson's diseases and essential tremor.
  This is a 6-week, open-label, single site clinical study designed to test whether treatment
        with peroneal electrical trans-cutaneous stimulation (eTNM) can have a beneficial effects on
        symptoms associated with Parkinson's diseases (PD) and essential tremor (ET). Eligible
        patients will be treated with eTNM at home for 6 weeks. Primary endpoint in this study is
        tolerability and safety, secondary and exploratory endpoints are various scale designed to
        capture improvements in the most bothersome symptoms of PD or ET.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Safety and tolerability
  time frame: Baseline to end of treatment at 6 weeks
  description: Incidence of treatment emergent adverse events
  measure: Efficacy
  time frame: Baseline to end of treatment at 6 weeks
  description: Change in Patient Global Impression of Improvement scale (Scores 1-7, lower number = better)
  measure: Exploratory efficacy
  time frame: Baseline to end of treatment at 6 weeks
  description: The Movement Disorders Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score (both total score and subscores) (applicable only for subjects with PD)(0-260, lower score = better)
  measure: Exploratory efficacy
  time frame: Baseline to end of treatment at 6 weeks
  description: Essential tremor rating assessment scale (TETRAS) score (applicable only for subjects with ET, 0-64, lower scores = better))
  measure: Exploratory efficacy
  time frame: Baseline to end of treatment at 6 weeks
  description: Bradykinesis and rigidity measured by Five Times Sit to Stand Test (FTSTS) (applicable only for subjects with PD, time in seconds, lower = better))
  measure: Exploratory efficacy
  time frame: Baseline to end of treatment at 6 weeks
  description: Bradykinesis and rigidity measured objectively using the 10 meter Walking Speed Test (WST) (time in seconds, lower = better)(applicable only for subjects with PD)
  measure: Exploratory efficacy
  time frame: Baseline to end of treatment at 6 weeks
  description: Effect on patient's daily activities measured by Bain and Findley Activities of Daily Living (BF-ADL) (25-100, lower score = better)
  measure: Exploratory efficacy
  time frame: Baseline to end of treatment at 6 weeks
  description: Degree of disability measured by modified Rankin Scale (mRS) (0-6, lower score= better)
  measure: Exploratory efficacy
  time frame: Baseline to end of treatment at 6 weeks
  description: Quality of life measured by European Quality of Life-5 Dimensions questionnaire (EQ-5D-5L)(0.532-1.000, higher score = better)
  measure: Exploratory efficacy
  time frame: Baseline to end of treatment at 6 weeks
  description: Disease-specific quality of life measured by Parkinson's Disease Questionnaire (PDQ -39)(0-100, lower score = better)
  measure: Exploratory efficacy
  time frame: Baseline to end of treatment at 6 weeks
  description: Patient's satisfaction using Treatment Satisfaction Visual Analog scale (TS-VAS)(0-100, higher score = better)
  arm group label: Peroneal eTNM arm
  arm group type: Experimental
  description: All patients will receive treatment with peroneal eTNM
  intervention type: Device
  intervention name: Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®)
  description: This is a non-invasive intervention, which utilizes direct trancutaneous, electrical stimulation of the peroneal nerve
  arm group label: Peroneal eTNM arm
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: David Skoloudik, MD, PhD
  role: Principal Investigator
  affiliation: Cerebrovaskulární poradna s.r.o., Ostrava
  last name: Roman V Dvorak, MD PhD
  phone: +420 734 577 837
  email: dvorak@stimvia.com
  last name: Lukas Doskocil
  phone: +420 776 721 127
  email: doskocil@stimvia.com
  facility: 
  contact: 
  country: Czechia
  responsible party type: Sponsor
  mesh term: Parkinson Disease
  mesh term: Tremor
  mesh term: Essential Tremor
  sharing ipd: No