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/NCT05989100</url>
    </required_header>
    <id_info>
      <org_study_id>KYLL-20230-024</org_study_id>
      <nct_id>NCT05989100</nct_id>
    </id_info>
    <brief_title>Taste Stimulation for Post-stroke Dysphagia</brief_title>
    <official_title>Effects of Taste Stimulation on Swallowing Function of Patient With Post-stroke Dysphagia and Its Mechanism</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Qilu Hospital of Shandong University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Shandong University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Qilu Hospital of Shandong University</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical study is to compare the effect of favourate taste stimulation of&#xD;
        oral cavity and tounge, with sour and traditional single thermal stimulation in post-stroke&#xD;
        patients with dysphagia. The main questions it aims to answer are:&#xD;
  &#xD;
          1. Whether favourate taste stimulation of oral and tounge is better than traditional&#xD;
             thermal stimulation in improving swallowing function of patients with dysphagia.&#xD;
  &#xD;
          2. It has been reported that taste of sour stimulation can increase the frequency of&#xD;
             swallowing. In this study, we want to know which is better for improving swallowing&#xD;
             function between favourate taste stimulation and sour taste stimulation.&#xD;
  &#xD;
          3. Functional near-infrared spectroscopy (fNIRS) will be applied in this study to&#xD;
             understand the neural mechanism of taste stimulation in improving swallowing function.&#xD;
  &#xD;
        Participants screened as post-stroke dysphagia will accept swallowing evaluation and fNIRS&#xD;
        test before and after treatment. The treatment include taste stimulation and traditional&#xD;
        swallowing training.&#xD;
  &#xD;
        Researchers will compare favourate taste stimulation with sour-taste stimulation and single&#xD;
        thermal stimulation to see if the swallowing function improved faster and better in favourate&#xD;
        taste stimulation group.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Taste perception can help to initiate swallow. Different taste has different impact on&#xD;
        swallowing function. Patients with post-stroke dysphagia always have taste impairment and&#xD;
        initiation delay of swallowing. In this study, patients with dysphagia after stroke will be&#xD;
        recruited and treated with favourate taste stimulation or sour taste stimulation or non-taste&#xD;
        stimulation for 2 weeks. Traditional swallowing rehabilitation will be applied base on the&#xD;
        status of patients. Before and after the treatment, participants completed swallowing&#xD;
        assessment, including quantitative measurement of hyoid displacement, functional oral intake&#xD;
        scale (FOIS), dysphagia severity rating scale (DSRS), and standardized swallowing assessment&#xD;
        (SSA). In order to understand the effect of taste stimulation on brain network, fNIRS will be&#xD;
        conducted.The participants have to conduct these examination three to four weeks after the&#xD;
        treatment to undertand the long-time effect of taste stimulation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2025</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>Favourate taste stimulation group, sour stimulation group and thermal stimulation group.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Hyoid displacement</measure>
      <time_frame>Befor and after the three-week treatment, and 3 weeks after the treatment.</time_frame>
      <description>The probe of ultrosound will be placed in the middle of the neck, paralled to the sagittal line. Record the video of participant drinking 1ml water, the distance between hyoid and chin at rest minus distance during hyoid and chin are nerest. Repeated three times, and the mean value is further into analysis.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>SSA</measure>
      <time_frame>Befor and after the three-week treatment, and 3 weeks after the treatment.</time_frame>
      <description>Standardized swallowing assessment (SSA) include clinical examination, drinking 5mL water test and drinking 60mL water test.lowest score is 18, and the highest score is 46, high score indicationg poor condition.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>FOIS</measure>
      <time_frame>Befor and after the three-week treatment, and 3 weeks after the treatment.</time_frame>
      <description>Functional oral intake scale. From one to seven, high score indicate better oral intake function.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>DSRS</measure>
      <time_frame>Befor and after the three-week treatment, and 3 weeks after the treatment.</time_frame>
      <description>The Dysphagia Severity Rating Scale (DSRS) assigns a score to the feeding status achieved by the dysphagic patient depending on the categories of feeding stage for fluid and dietary consumption in addition to the level of dependency required for feeding. The score for each category can vary between 0 and 4 points, and is added to give a composite score. These scores were calculated by a speech and language therapist with special interest in neurogenic dysphagia. SALT：speech and language therapist.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>fNIRS</measure>
      <time_frame>Befor and after the three-week treatment, and 3 weeks after the treatment.</time_frame>
      <description>Functional near-infrared spectroscopy (fNIRS) is a tool for measuring the HbO2 concentration to reflect the excitation of cortex. Further analysis can help to explain the network of the brain.</description>
    </other_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">87</enrollment>
    <condition>Stroke</condition>
    <condition>Dysphagia</condition>
    <arm_group>
      <arm_group_label>Favourate taste stimulation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The swab will be immersed in sugar, salt, citric acid, or paprika mixed with water, and be placed in -18℃ refrigerator. Select the swabs of the participant favourate taste to brush oral cavity and tounge. The stimulation will last two to three minutes one time, and twice for a rehabilitation session, once per day and six days every week, three weeks totally. Swallowing rehabilitation also include standard training that carried out in the department.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sour stimulation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Using sour swab to brush oral cavity and tounge of the participant. The treatment duration and other training method is as same as mentioned above.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Thermal stimulation</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Only ice-water swab to brush oral cavity and tounge. The treatment duration and other training method is as same as mentioned above.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Favourate taste stimulation</intervention_name>
      <description>The taste stimulaiton for swallowing is completed with long swab. Taste solution will be prepared with sugar, salt, citric acid, or paprika mixed with water. And the swab will be immersed in the solution and freezed in -18℃ circumstances. Bilateral buccal mucosa，palate and tounge will be brushed. Four swabs will be used in a training session.</description>
      <arm_group_label>Favourate taste stimulation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Sour taste stimulation</intervention_name>
      <description>Using sour swab to brush oral cavity and tounge.</description>
      <arm_group_label>Sour stimulation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Thermal stimulation group</intervention_name>
      <description>Only ice-water swab to brush oral cavity and tounge.</description>
      <arm_group_label>Thermal stimulation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. diagnosed as first-ever stroke and diagnosed as dysphagia with modified water&#xD;
               swallowing test, duration of dysphagia was more than one month;&#xD;
  &#xD;
            2. can complete all the test with MMSE &gt;15;&#xD;
  &#xD;
            3. agree to participate the experiment, and sign the written informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. have other diseases that could induce dysphagia, such as cranial and neck tumor,&#xD;
               history of radiotherapy or chemotherapy, tongue muscle atrophy, myasthenia gravis,&#xD;
               parotid tumor and multiple sclerosis, etc;&#xD;
  &#xD;
            2. lose of taste perception;&#xD;
  &#xD;
            3. combined with other major disease that can not tolerate the examination and swallowing&#xD;
               training;&#xD;
  &#xD;
            4. surgery of cranial allogeneic plasticity, scalp ulcer or damage that thought as&#xD;
               contraindications of fNIRS.&#xD;
  &#xD;
            5. with other neurological conditions (eg, Parkinson's disease, dementia).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yonghui Wang, professor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Qilu Hospital of Shandong University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yonghui Wang, professor</last_name>
      <phone>86-18560083581</phone>
      <email>yonghuiwangphd@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Yonghui Wang</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <zip>250012</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yonghui Wang, professor</last_name>
        <phone>86-18560083581</phone>
        <email>yonghuiwangphd@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Nowrin I, Bhattacharyya DS, Saif-Ur-Rahman KM. Community-based interventions to prevent stroke in low-income and middle-income countries: a protocol for a systematic review and meta-analysis. BMJ Open. 2022 Aug 8;12(8):e063181. doi: 10.1136/bmjopen-2022-063181.</citation>
      <PMID>35940843</PMID>
    </reference>
    <reference>
      <citation>Chiang CF, Lin MT, Hsiao MY, Yeh YC, Liang YC, Wang TG. Comparative Efficacy of Noninvasive Neurostimulation Therapies for Acute and Subacute Poststroke Dysphagia: A Systematic Review and Network Meta-analysis. Arch Phys Med Rehabil. 2019 Apr;100(4):739-750.e4. doi: 10.1016/j.apmr.2018.09.117. Epub 2018 Oct 21.</citation>
      <PMID>30352222</PMID>
    </reference>
    <reference>
      <citation>Palmer PM, McCulloch TM, Jaffe D, Neel AT. Effects of a sour bolus on the intramuscular electromyographic (EMG) activity of muscles in the submental region. Dysphagia. 2005 Summer;20(3):210-7. doi: 10.1007/s00455-005-0017-x.</citation>
      <PMID>16362509</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 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 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>taste stimulation</keyword>
    <keyword>sour stimulaiton</keyword>
    <keyword>thermal stimulation</keyword>
    <keyword>functional near-inrared spectroscopy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Deglutition Disorders</mesh_term>
      <mesh_term>Stroke</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/NCT05989100
  org study id: KYLL-20230-024
  nct id: NCT05989100
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical study is to compare the effect of favourate taste stimulation of
        oral cavity and tounge, with sour and traditional single thermal stimulation in post-stroke
        patients with dysphagia. The main questions it aims to answer are:
  
          1. Whether favourate taste stimulation of oral and tounge is better than traditional
             thermal stimulation in improving swallowing function of patients with dysphagia.
  
          2. It has been reported that taste of sour stimulation can increase the frequency of
             swallowing. In this study, we want to know which is better for improving swallowing
             function between favourate taste stimulation and sour taste stimulation.
  
          3. Functional near-infrared spectroscopy (fNIRS) will be applied in this study to
             understand the neural mechanism of taste stimulation in improving swallowing function.
  
        Participants screened as post-stroke dysphagia will accept swallowing evaluation and fNIRS
        test before and after treatment. The treatment include taste stimulation and traditional
        swallowing training.
  
        Researchers will compare favourate taste stimulation with sour-taste stimulation and single
        thermal stimulation to see if the swallowing function improved faster and better in favourate
        taste stimulation group.
  Taste perception can help to initiate swallow. Different taste has different impact on
        swallowing function. Patients with post-stroke dysphagia always have taste impairment and
        initiation delay of swallowing. In this study, patients with dysphagia after stroke will be
        recruited and treated with favourate taste stimulation or sour taste stimulation or non-taste
        stimulation for 2 weeks. Traditional swallowing rehabilitation will be applied base on the
        status of patients. Before and after the treatment, participants completed swallowing
        assessment, including quantitative measurement of hyoid displacement, functional oral intake
        scale (FOIS), dysphagia severity rating scale (DSRS), and standardized swallowing assessment
        (SSA). In order to understand the effect of taste stimulation on brain network, fNIRS will be
        conducted.The participants have to conduct these examination three to four weeks after the
        treatment to undertand the long-time effect of taste stimulation.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Favourate taste stimulation group, sour stimulation group and thermal stimulation group.
  primary purpose: Treatment
  masking: Double (Care Provider, Outcomes Assessor)
  measure: Hyoid displacement
  time frame: Befor and after the three-week treatment, and 3 weeks after the treatment.
  description: The probe of ultrosound will be placed in the middle of the neck, paralled to the sagittal line. Record the video of participant drinking 1ml water, the distance between hyoid and chin at rest minus distance during hyoid and chin are nerest. Repeated three times, and the mean value is further into analysis.
  measure: SSA
  time frame: Befor and after the three-week treatment, and 3 weeks after the treatment.
  description: Standardized swallowing assessment (SSA) include clinical examination, drinking 5mL water test and drinking 60mL water test.lowest score is 18, and the highest score is 46, high score indicationg poor condition.
  measure: FOIS
  time frame: Befor and after the three-week treatment, and 3 weeks after the treatment.
  description: Functional oral intake scale. From one to seven, high score indicate better oral intake function.
  measure: DSRS
  time frame: Befor and after the three-week treatment, and 3 weeks after the treatment.
  description: The Dysphagia Severity Rating Scale (DSRS) assigns a score to the feeding status achieved by the dysphagic patient depending on the categories of feeding stage for fluid and dietary consumption in addition to the level of dependency required for feeding. The score for each category can vary between 0 and 4 points, and is added to give a composite score. These scores were calculated by a speech and language therapist with special interest in neurogenic dysphagia. SALT：speech and language therapist.
  measure: fNIRS
  time frame: Befor and after the three-week treatment, and 3 weeks after the treatment.
  description: Functional near-infrared spectroscopy (fNIRS) is a tool for measuring the HbO2 concentration to reflect the excitation of cortex. Further analysis can help to explain the network of the brain.
  arm group label: Favourate taste stimulation
  arm group type: Experimental
  description: The swab will be immersed in sugar, salt, citric acid, or paprika mixed with water, and be placed in -18℃ refrigerator. Select the swabs of the participant favourate taste to brush oral cavity and tounge. The stimulation will last two to three minutes one time, and twice for a rehabilitation session, once per day and six days every week, three weeks totally. Swallowing rehabilitation also include standard training that carried out in the department.
  arm group label: Sour stimulation
  arm group type: Active Comparator
  description: Using sour swab to brush oral cavity and tounge of the participant. The treatment duration and other training method is as same as mentioned above.
  arm group label: Thermal stimulation
  arm group type: Placebo Comparator
  description: Only ice-water swab to brush oral cavity and tounge. The treatment duration and other training method is as same as mentioned above.
  intervention type: Behavioral
  intervention name: Favourate taste stimulation
  description: The taste stimulaiton for swallowing is completed with long swab. Taste solution will be prepared with sugar, salt, citric acid, or paprika mixed with water. And the swab will be immersed in the solution and freezed in -18℃ circumstances. Bilateral buccal mucosa，palate and tounge will be brushed. Four swabs will be used in a training session.
  arm group label: Favourate taste stimulation
  intervention type: Behavioral
  intervention name: Sour taste stimulation
  description: Using sour swab to brush oral cavity and tounge.
  arm group label: Sour stimulation
  intervention type: Behavioral
  intervention name: Thermal stimulation group
  description: Only ice-water swab to brush oral cavity and tounge.
  arm group label: Thermal stimulation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Yonghui Wang, professor
  role: Principal Investigator
  affiliation: Qilu Hospital of Shandong University
  last name: Yonghui Wang, professor
  phone: 86-18560083581
  email: yonghuiwangphd@163.com
  facility: 
  contact: 
  country: China
  citation: Nowrin I, Bhattacharyya DS, Saif-Ur-Rahman KM. Community-based interventions to prevent stroke in low-income and middle-income countries: a protocol for a systematic review and meta-analysis. BMJ Open. 2022 Aug 8;12(8):e063181. doi: 10.1136/bmjopen-2022-063181.
  PMID: 35940843
  citation: Chiang CF, Lin MT, Hsiao MY, Yeh YC, Liang YC, Wang TG. Comparative Efficacy of Noninvasive Neurostimulation Therapies for Acute and Subacute Poststroke Dysphagia: A Systematic Review and Network Meta-analysis. Arch Phys Med Rehabil. 2019 Apr;100(4):739-750.e4. doi: 10.1016/j.apmr.2018.09.117. Epub 2018 Oct 21.
  PMID: 30352222
  citation: Palmer PM, McCulloch TM, Jaffe D, Neel AT. Effects of a sour bolus on the intramuscular electromyographic (EMG) activity of muscles in the submental region. Dysphagia. 2005 Summer;20(3):210-7. doi: 10.1007/s00455-005-0017-x.
  PMID: 16362509
  responsible party type: Sponsor
  mesh term: Deglutition Disorders
  mesh term: Stroke
  sharing ipd: No