<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/NCT03253354</url>
  </required_header>
  <id_info>
    <org_study_id>IRAS: 200591</org_study_id>
    <nct_id>NCT03253354</nct_id>
  </id_info>
  <brief_title>Neurostimulation for Dysphagia in Parkinson's Disease</brief_title>
  <official_title>Exploring Novel Neurostimulation Based Therapies for Swallowing Impairments in Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manchester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Northern Care Alliance NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Manchester</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>
      This study will explore the effects of 3 different neurostimulation methods on swallowing&#xD;
      function in patients with dysphagia secondary to Parkinson's Disease&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to assess 3 novel neuromodulation approaches - namely, pharyngeal&#xD;
      stimulation, high frequency (5Hz) repetitive transcranial magnetic stimulation and low&#xD;
      frequency (1Hz) repetitive transcranial magnetic stimulation on swallowing function in&#xD;
      patients with dysphagia after Parkinson's Disease. A total of 66 patients are planned to be&#xD;
      recruited, randomised to one of the 3 technologies or a sham treatment. A single treatment&#xD;
      will be given and the effects will be assessed with a barium exam called videofluoroscopy&#xD;
      within the 1st hour after the treatment. In addition, some measures of brain function will be&#xD;
      recorded, before and after the treatments using single pulse transcranial magnetic&#xD;
      stimulation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">August 30, 2021</completion_date>
  <primary_completion_date type="Actual">April 30, 2021</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>4 arm randomised single dose study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Patient blinding</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Videofluoroscopy</measure>
    <time_frame>1 hour</time_frame>
    <description>Changes in penetration aspiration scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brain excitability</measure>
    <time_frame>Immediately after, 30 and 60 minutes</time_frame>
    <description>Measures of brain function to single pulse TMS</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Dysphagia</condition>
  <condition>Parkinson Disease</condition>
  <condition>Swallowing Disorder.Other Specified</condition>
  <condition>Brain Diseases</condition>
  <arm_group>
    <arm_group_label>Pharyngeal stimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pharyngeal stimulation given at 5Hz for 10 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>repetitive magnetic stimulation (1Hz)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>repetitive transcranial magnetic stimulation at 1Hz applied for 600 pulses</description>
  </arm_group>
  <arm_group>
    <arm_group_label>repetitive magnetic stimulation (5Hz)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>repetitive transcranial magnetic stimulation at 5Hz applied for 600 pulses</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham treatment</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham repetitive transcranial magnetic stimulation using the coil tilt technique</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>repetitive magnetic stimulation</intervention_name>
    <description>Neurostimulation</description>
    <arm_group_label>Pharyngeal stimulation</arm_group_label>
    <arm_group_label>Sham treatment</arm_group_label>
    <arm_group_label>repetitive magnetic stimulation (1Hz)</arm_group_label>
    <arm_group_label>repetitive magnetic stimulation (5Hz)</arm_group_label>
    <other_name>pharyngeal stimulation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Confirmed Parkinson's Disease with dysphagia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Contraindications to magnetic stimulation, such as pacemakers, significant neuroleptic&#xD;
        medications, pregnancy Other causes for dysphagia Unable to give informed written consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shaheen Hamdy, PhD FRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Manchester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Salford Royal Hospital</name>
      <address>
        <city>Salford</city>
        <state>Manchester</state>
        <zip>M6 8HD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>June 8, 2022</last_update_submitted>
  <last_update_submitted_qc>June 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Manchester</investigator_affiliation>
    <investigator_full_name>Prof Shaheen Hamdy PhD FRCP</investigator_full_name>
    <investigator_title>Professor of Neurogastroenterology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deglutition Disorders</mesh_term>
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Brain Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Anonymized swallowing physiology data</ipd_description>
  </patient_data>
  <!-- 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/NCT03253354
org study id: IRAS: 200591
nct id: NCT03253354
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will explore the effects of 3 different neurostimulation methods on swallowing
      function in patients with dysphagia secondary to Parkinson's Disease
The aim of this study is to assess 3 novel neuromodulation approaches - namely, pharyngeal
      stimulation, high frequency (5Hz) repetitive transcranial magnetic stimulation and low
      frequency (1Hz) repetitive transcranial magnetic stimulation on swallowing function in
      patients with dysphagia after Parkinson's Disease. A total of 66 patients are planned to be
      recruited, randomised to one of the 3 technologies or a sham treatment. A single treatment
      will be given and the effects will be assessed with a barium exam called videofluoroscopy
      within the 1st hour after the treatment. In addition, some measures of brain function will be
      recorded, before and after the treatments using single pulse transcranial magnetic
      stimulation.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 4 arm randomised single dose study
primary purpose: Treatment
masking: Single (Participant)
masking description: Patient blinding
measure: Videofluoroscopy
time frame: 1 hour
description: Changes in penetration aspiration scale
measure: Brain excitability
time frame: Immediately after, 30 and 60 minutes
description: Measures of brain function to single pulse TMS
arm group label: Pharyngeal stimulation
arm group type: Active Comparator
description: Pharyngeal stimulation given at 5Hz for 10 minutes
arm group label: repetitive magnetic stimulation (1Hz)
arm group type: Active Comparator
description: repetitive transcranial magnetic stimulation at 1Hz applied for 600 pulses
arm group label: repetitive magnetic stimulation (5Hz)
arm group type: Active Comparator
description: repetitive transcranial magnetic stimulation at 5Hz applied for 600 pulses
arm group label: Sham treatment
arm group type: Sham Comparator
description: Sham repetitive transcranial magnetic stimulation using the coil tilt technique
intervention type: Device
intervention name: repetitive magnetic stimulation
description: Neurostimulation
arm group label: Pharyngeal stimulation
arm group label: Sham treatment
arm group label: repetitive magnetic stimulation (1Hz)
arm group label: repetitive magnetic stimulation (5Hz)
other name: pharyngeal stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shaheen Hamdy, PhD FRCP
role: Principal Investigator
affiliation: University of Manchester
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Manchester
investigator full name: Prof Shaheen Hamdy PhD FRCP
investigator title: Professor of Neurogastroenterology
mesh term: Deglutition Disorders
mesh term: Parkinson Disease
mesh term: Brain Diseases
sharing ipd: Undecided
ipd description: Anonymized swallowing physiology data