<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/NCT03797976</url>
  </required_header>
  <id_info>
    <org_study_id>Hatay Mustafa Kemal U 1</org_study_id>
    <nct_id>NCT03797976</nct_id>
  </id_info>
  <brief_title>The Effects Of DBS Of Subthalamıc Nucleus On Functionality In Patıents With Parkinson's Disease: Short-Term Results</brief_title>
  <official_title>The Effects Of Deep Brain Stimulation Of Subthalamıc Nucleus On Pulmonary Function Tests and Functionality In Patıents With Parkinson's Disease: Short Term Results</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mustafa Kemal University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mustafa Kemal University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Parkinson's disease is a progressive chronic neurodegenerative disease. In cases where drug&#xD;
      treatment is insufficient and drug use is not possible due to drug side effects, highly&#xD;
      effective and low-risk surgical treatment options could be used. In Parkinson's Disease;&#xD;
      findings such as chest wall rigidity and weakness of the respiratory muscle strength occur.&#xD;
      The aim of this study was to determine the effect of preop and postop DBS surgery on&#xD;
      respiratory muscle strength, respiratory function and physical performance in patients with&#xD;
      Parkinson's disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the study, at least 10 patients with Parkinson's disease who had DBS surgery in Mustafa&#xD;
      Kemal University Research and Practice Hospital, Department of Brain and Nerve Surgery will&#xD;
      be evaluated. Demographic-physical features, pulmonary functions, respiratory muscle&#xD;
      strength, exercise capacity, functionality, and muscle strength will be evaluated&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">December 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2019</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functional exercise capacity</measure>
    <time_frame>Change from Baseline Functional exercise capacity at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months</time_frame>
    <description>6 minute walking test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pulmonary functions</measure>
    <time_frame>Change from Pulmonary functions at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months</time_frame>
    <description>Spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inspiratory and expiratory muscle strength (MIP, MEP)</measure>
    <time_frame>Change from Inspiratory and expiratory muscle strength (MIP, MEP) at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months</time_frame>
    <description>Mouth pressure device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle strength</measure>
    <time_frame>Change from Peripheral muscle strength at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months</time_frame>
    <description>Muscle Testing Device (N)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grip Test (Peripheral muscle strength)</measure>
    <time_frame>Change from Peripheral muscle strength at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months</time_frame>
    <description>Hand Held Dynamometer (kgf)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Parkinson Disease</condition>
  <condition>Surgery</condition>
  <condition>Respiration; Decreased</condition>
  <condition>Muscle Weakness</condition>
  <arm_group>
    <arm_group_label>Parkinson's Disease Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MIP and MEP Respiratory Function Test Strength Test</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MIP and MEP</intervention_name>
    <description>Pre-op, Post-op of, 1 month after surgery, 3 months after surgery</description>
    <arm_group_label>Parkinson's Disease Group</arm_group_label>
    <other_name>Respiratory Function Test</other_name>
    <other_name>Muscle Test</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Lack of any neurological disease other than Parkinson's&#xD;
&#xD;
          -  DBS surgery to be performed in the STN region&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with advanced cognitive impairment&#xD;
&#xD;
          -  Patients with pulmonary, neurological and orthopedic diseases affecting&#xD;
             functionalities&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Patients in whom the stimulation was canceled due to infection after surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Deran Oskay, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Gazi University Faculty of Health Science Department of Physical Therapy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bircan Yucekaya, MSc</last_name>
    <role>Study Chair</role>
    <affiliation>Hatay Mustafa Kemal University School of Physical Therapy and Rehabilitation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Atilla Yılmaz, Med. Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hatay Mustafa Kemal University Department of Neurosurgery</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Deran Oskay, PhD</last_name>
    <phone>0312 2162600</phone>
    <phone_ext>2162627</phone_ext>
    <email>deranoskay@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Bircan Yucekaya, MSc</last_name>
    <phone>03262455516</phone>
    <phone_ext>15514</phone_ext>
    <email>bircanyucekaya@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hatay Mustafa Kemal University</name>
      <address>
        <city>Antakya</city>
        <state>Hatay</state>
        <zip>30100</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bircan Yucekaya, MSc</last_name>
      <phone>+903262455516</phone>
      <phone_ext>15514</phone_ext>
      <email>bircanyucekaya@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Deran Oskay, PhD</last_name>
      <phone>312 2162600</phone>
      <phone_ext>2162627</phone_ext>
      <email>deranoskay@yahoo.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Stemper B, Beric A, Welsch G, Haendl T, Sterio D, Hilz MJ. Deep brain stimulation improves orthostatic regulation of patients with Parkinson disease. Neurology. 2006 Nov 28;67(10):1781-5. doi: 10.1212/01.wnl.0000244416.30605.f1.</citation>
    <PMID>17130410</PMID>
  </reference>
  <reference>
    <citation>Trachani E, Constantoyannis C, Sirrou V, Kefalopoulou Z, Markaki E, Chroni E. Effects of subthalamic nucleus deep brain stimulation on sweating function in Parkinson's disease. Clin Neurol Neurosurg. 2010 Apr;112(3):213-7. doi: 10.1016/j.clineuro.2009.11.015. Epub 2009 Dec 22.</citation>
    <PMID>20022689</PMID>
  </reference>
  <reference>
    <citation>Hyam JA, Brittain JS, Paterson DJ, Davies RJ, Aziz TZ, Green AL. Controlling the lungs via the brain: a novel neurosurgical method to improve lung function in humans. Neurosurgery. 2012 Feb;70(2):469-77; discussion 477-8. doi: 10.1227/NEU.0b013e318231d789.</citation>
    <PMID>21841525</PMID>
  </reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>March 14, 2019</last_update_submitted>
  <last_update_submitted_qc>March 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mustafa Kemal University</investigator_affiliation>
    <investigator_full_name>Bircan Yücekaya</investigator_full_name>
    <investigator_title>Lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Weakness</mesh_term>
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03797976
org study id: Hatay Mustafa Kemal U 1
nct id: NCT03797976
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Parkinson's disease is a progressive chronic neurodegenerative disease. In cases where drug
      treatment is insufficient and drug use is not possible due to drug side effects, highly
      effective and low-risk surgical treatment options could be used. In Parkinson's Disease;
      findings such as chest wall rigidity and weakness of the respiratory muscle strength occur.
      The aim of this study was to determine the effect of preop and postop DBS surgery on
      respiratory muscle strength, respiratory function and physical performance in patients with
      Parkinson's disease.
In the study, at least 10 patients with Parkinson's disease who had DBS surgery in Mustafa
      Kemal University Research and Practice Hospital, Department of Brain and Nerve Surgery will
      be evaluated. Demographic-physical features, pulmonary functions, respiratory muscle
      strength, exercise capacity, functionality, and muscle strength will be evaluated
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Functional exercise capacity
time frame: Change from Baseline Functional exercise capacity at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months
description: 6 minute walking test
measure: Pulmonary functions
time frame: Change from Pulmonary functions at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months
description: Spirometry
measure: Inspiratory and expiratory muscle strength (MIP, MEP)
time frame: Change from Inspiratory and expiratory muscle strength (MIP, MEP) at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months
description: Mouth pressure device
measure: Muscle strength
time frame: Change from Peripheral muscle strength at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months
description: Muscle Testing Device (N)
measure: Grip Test (Peripheral muscle strength)
time frame: Change from Peripheral muscle strength at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months
description: Hand Held Dynamometer (kgf)
arm group label: Parkinson's Disease Group
arm group type: Experimental
description: MIP and MEP Respiratory Function Test Strength Test
intervention type: Device
intervention name: MIP and MEP
description: Pre-op, Post-op of, 1 month after surgery, 3 months after surgery
arm group label: Parkinson's Disease Group
other name: Respiratory Function Test
other name: Muscle Test
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Deran Oskay, PhD
role: Study Director
affiliation: Gazi University Faculty of Health Science Department of Physical Therapy
last name: Bircan Yucekaya, MSc
role: Study Chair
affiliation: Hatay Mustafa Kemal University School of Physical Therapy and Rehabilitation
last name: Atilla Yılmaz, Med. Dr
role: Principal Investigator
affiliation: Hatay Mustafa Kemal University Department of Neurosurgery
last name: Deran Oskay, PhD
phone: 0312 2162600
phone ext: 2162627
email: deranoskay@yahoo.com
last name: Bircan Yucekaya, MSc
phone: 03262455516
phone ext: 15514
email: bircanyucekaya@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Turkey
citation: Stemper B, Beric A, Welsch G, Haendl T, Sterio D, Hilz MJ. Deep brain stimulation improves orthostatic regulation of patients with Parkinson disease. Neurology. 2006 Nov 28;67(10):1781-5. doi: 10.1212/01.wnl.0000244416.30605.f1.
PMID: 17130410
citation: Trachani E, Constantoyannis C, Sirrou V, Kefalopoulou Z, Markaki E, Chroni E. Effects of subthalamic nucleus deep brain stimulation on sweating function in Parkinson's disease. Clin Neurol Neurosurg. 2010 Apr;112(3):213-7. doi: 10.1016/j.clineuro.2009.11.015. Epub 2009 Dec 22.
PMID: 20022689
citation: Hyam JA, Brittain JS, Paterson DJ, Davies RJ, Aziz TZ, Green AL. Controlling the lungs via the brain: a novel neurosurgical method to improve lung function in humans. Neurosurgery. 2012 Feb;70(2):469-77; discussion 477-8. doi: 10.1227/NEU.0b013e318231d789.
PMID: 21841525
responsible party type: Principal Investigator
investigator affiliation: Mustafa Kemal University
investigator full name: Bircan Yücekaya
investigator title: Lecturer
mesh term: Muscle Weakness
mesh term: Parkinson Disease
sharing ipd: No