<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/NCT03787420</url>
  </required_header>
  <id_info>
    <org_study_id>107-3011-F-027-002-</org_study_id>
    <nct_id>NCT03787420</nct_id>
  </id_info>
  <brief_title>Development and Needs Assessment and Efficiency of Smart Communication System for Patients With ALS.</brief_title>
  <official_title>Development and Needs Assessment and Efficiency of Smart Communication System for Patients With ALS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Veterans General Hospital, Taiwan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Veterans General Hospital, Taiwan</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project aims to develop a smart communication system for patients with amyotrophic&#xD;
      lateral sclerosis (ALS), especially for stage 3 and stage 4 (late stage). Patients with ALS&#xD;
      will be able to communicate with outer environment by means of mental control or eye tracking&#xD;
      control, which would increase their life quality. This integrated research project includes&#xD;
      experts from different domains and proposes a solution for smart communication system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A multi-function brain- computer interface (BCI) communication system will be developed by&#xD;
      combining a BCI system (subproject 1) and a 3D electro-cap (subproject 3). Then, this system&#xD;
      and an eye-controlled device (subject 2) are further integrated to a smart communication&#xD;
      system. The outputs of the system are presented with the original voice the ALS patients,&#xD;
      which will be achieved by using the voice reconstruction technology (subproject 4) in this&#xD;
      project. All the user-interfaces of the BCI and eye tracking systems will be re-deigned by&#xD;
      employing human factors engineering to increase the usability of the proposed smart&#xD;
      communication system for ALS. Finally, the validity of the system in improving the life&#xD;
      quality of ALS will be assessed through clinical study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2019</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>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Part 1- Amyotrophic Lateral Sclerosis Supportive Care Needs</measure>
    <time_frame>30mins</time_frame>
    <description>To comprehensively assess the perceived supportive care needs of patients with ALS.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2 - Amyotrophic Lateral Sclerosis Specific Quality of Life Instrument-Revisedclinical study</measure>
    <time_frame>one week</time_frame>
    <description>We try to understand the validity of the system. This measurement can help us know that our system could be beneficial or not on the quality of life in patient with ALS.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Part 2 - Beck Depression Inventoryc</measure>
    <time_frame>one week</time_frame>
    <description>We try to understand the validity of the system. This measurement can help us know that our system could be beneficial or not on the degree of depression of life in patient with ALS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver Burden Scale</measure>
    <time_frame>one week</time_frame>
    <description>We try to understand the validity of the system. This measurement can help us know that our system could be beneficial or not on the burden in patient's caregiver.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>ALS (Amyotrophic Lateral Sclerosis)</condition>
  <arm_group>
    <arm_group_label>traditional communication system</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>intelligent communication system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>communication system</intervention_name>
    <description>We will use the questionnaire &quot;Amyotrophic Lateral Sclerosis Supportive Care Needs ,Amyotrophic Lateral Sclerosis Specific Quality of Life Instrument-Revised, Beck Depression Inventory and Caregiver Burden Scale.</description>
    <arm_group_label>intelligent communication system</arm_group_label>
    <arm_group_label>traditional communication system</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Part one:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  ALS diagnostic criteria (Brooks et al., 2000).Must have the following characteristics:&#xD;
&#xD;
               1. Degeneration of motor neurons (LMN) by clinical, electrophysiological or&#xD;
                  neuropathological evidence.&#xD;
&#xD;
               2. Degeneration of upper motor neurons (UMN) is demonstrated by clinical&#xD;
                  examination.&#xD;
&#xD;
               3. According to the medical history or examination, the symptoms or signs gradually&#xD;
                  disappear in a certain part.&#xD;
&#xD;
        Also, there are no features:&#xD;
&#xD;
          1. Electrophysiological or pathological evidence of other diseases that may explain signs&#xD;
             of LMN and/or UMN degradation&#xD;
&#xD;
          2. Neuroimaging evidence of other diseases that may explain the observed clinical&#xD;
             electrophysiological signs.&#xD;
&#xD;
               -  Use Mandarin as the main language.&#xD;
&#xD;
               -  Age limits minimum is 20&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concomitant other central nervous disorders that interfere with their cognitive&#xD;
             function, such as dementia, severe depression, and psychosis.&#xD;
&#xD;
          -  The questionnaire cannot be completed without the assistance of others.&#xD;
&#xD;
        Part two:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  ALS diagnostic criteria (Brooks et al., 2000).&#xD;
&#xD;
          -  Use Mandarin as the main language.&#xD;
&#xD;
          -  Age limits minimum is 20&#xD;
&#xD;
          -  In everyday oral communication, people who are consciously difficult.&#xD;
&#xD;
          -  Ability to perform equipment wear and system operators.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concomitant other central nervous disorders that interfere with their cognitive&#xD;
             function, such as dementia, severe depression, and psychosis.&#xD;
&#xD;
          -  After correction, the visual acuity cannot see the communication board.&#xD;
&#xD;
          -  The scalp is sensitive or there is deep brain stimulation, etc. It is not applicable&#xD;
             to brain wave measurement.&#xD;
&#xD;
          -  -The questionnaire cannot be completed without the assistance of others.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Cheng Liang Chou</last_name>
    <phone>+8862-28757296</phone>
    <email>cl_chou@vghtpe.gov.tw</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>SI-HUEI LEE</last_name>
    <phone>+886938591985</phone>
    <email>leesihuei@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cancer Center, Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cheng Liang Chou</last_name>
      <phone>+8862-28757296</phone>
      <email>cl_chou@vghtpe.gov.tw</email>
    </contact>
    <contact_backup>
      <last_name>SI-HUEI LEE</last_name>
      <phone>+886938591985</phone>
      <email>leesihuei@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>October 25, 2018</study_first_submitted>
  <study_first_submitted_qc>December 24, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>December 24, 2018</last_update_submitted>
  <last_update_submitted_qc>December 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 2018</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>Motor Neuron Disease</mesh_term>
    <mesh_term>Amyotrophic Lateral Sclerosis</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/NCT03787420
org study id: 107-3011-F-027-002-
nct id: NCT03787420
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This project aims to develop a smart communication system for patients with amyotrophic
      lateral sclerosis (ALS), especially for stage 3 and stage 4 (late stage). Patients with ALS
      will be able to communicate with outer environment by means of mental control or eye tracking
      control, which would increase their life quality. This integrated research project includes
      experts from different domains and proposes a solution for smart communication system.
A multi-function brain- computer interface (BCI) communication system will be developed by
      combining a BCI system (subproject 1) and a 3D electro-cap (subproject 3). Then, this system
      and an eye-controlled device (subject 2) are further integrated to a smart communication
      system. The outputs of the system are presented with the original voice the ALS patients,
      which will be achieved by using the voice reconstruction technology (subproject 4) in this
      project. All the user-interfaces of the BCI and eye tracking systems will be re-deigned by
      employing human factors engineering to increase the usability of the proposed smart
      communication system for ALS. Finally, the validity of the system in improving the life
      quality of ALS will be assessed through clinical study.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Part 1- Amyotrophic Lateral Sclerosis Supportive Care Needs
time frame: 30mins
description: To comprehensively assess the perceived supportive care needs of patients with ALS.
measure: Part 2 - Amyotrophic Lateral Sclerosis Specific Quality of Life Instrument-Revisedclinical study
time frame: one week
description: We try to understand the validity of the system. This measurement can help us know that our system could be beneficial or not on the quality of life in patient with ALS.
measure: Part 2 - Beck Depression Inventoryc
time frame: one week
description: We try to understand the validity of the system. This measurement can help us know that our system could be beneficial or not on the degree of depression of life in patient with ALS.
measure: Caregiver Burden Scale
time frame: one week
description: We try to understand the validity of the system. This measurement can help us know that our system could be beneficial or not on the burden in patient's caregiver.
arm group label: traditional communication system
arm group type: Active Comparator
arm group label: intelligent communication system
arm group type: Experimental
intervention type: Other
intervention name: communication system
description: We will use the questionnaire "Amyotrophic Lateral Sclerosis Supportive Care Needs ,Amyotrophic Lateral Sclerosis Specific Quality of Life Instrument-Revised, Beck Depression Inventory and Caregiver Burden Scale.
arm group label: intelligent communication system
arm group label: traditional communication system
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Cheng Liang Chou
phone: +8862-28757296
email: cl_chou@vghtpe.gov.tw
last name: SI-HUEI LEE
phone: +886938591985
email: leesihuei@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Taiwan
responsible party type: Sponsor
mesh term: Motor Neuron Disease
mesh term: Amyotrophic Lateral Sclerosis