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The Effects Of DBS Of Subthalamıc Nucleus On Functionality In Patıents With Parkinson's Disease: Short-Term Results

Primary Purpose

Parkinson Disease, Surgery, Respiration; Decreased

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
MIP and MEP
Sponsored by
Mustafa Kemal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Lack of any neurological disease other than Parkinson's
  • DBS surgery to be performed in the STN region

Exclusion Criteria:

  • Patients with advanced cognitive impairment
  • Patients with pulmonary, neurological and orthopedic diseases affecting functionalities
  • Pregnancy
  • Patients in whom the stimulation was canceled due to infection after surgery.

Sites / Locations

  • Hatay Mustafa Kemal UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Parkinson's Disease Group

Arm Description

MIP and MEP Respiratory Function Test Strength Test

Outcomes

Primary Outcome Measures

Functional exercise capacity
6 minute walking test

Secondary Outcome Measures

Pulmonary functions
Spirometry
Inspiratory and expiratory muscle strength (MIP, MEP)
Mouth pressure device
Muscle strength
Muscle Testing Device (N)
Grip Test (Peripheral muscle strength)
Hand Held Dynamometer (kgf)

Full Information

First Posted
December 18, 2018
Last Updated
March 14, 2019
Sponsor
Mustafa Kemal University
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1. Study Identification

Unique Protocol Identification Number
NCT03797976
Brief Title
The Effects Of DBS Of Subthalamıc Nucleus On Functionality In Patıents With Parkinson's Disease: Short-Term Results
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mustafa Kemal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Surgery, Respiration; Decreased, Muscle Weakness

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Parkinson's Disease Group
Arm Type
Experimental
Arm Description
MIP and MEP Respiratory Function Test Strength Test
Intervention Type
Device
Intervention Name(s)
MIP and MEP
Other Intervention Name(s)
Respiratory Function Test, Muscle Test
Intervention Description
Pre-op, Post-op of, 1 month after surgery, 3 months after surgery
Primary Outcome Measure Information:
Title
Functional exercise capacity
Description
6 minute walking test
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
Secondary Outcome Measure Information:
Title
Pulmonary functions
Description
Spirometry
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
Title
Inspiratory and expiratory muscle strength (MIP, MEP)
Description
Mouth pressure device
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
Title
Muscle strength
Description
Muscle Testing Device (N)
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
Title
Grip Test (Peripheral muscle strength)
Description
Hand Held Dynamometer (kgf)
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Lack of any neurological disease other than Parkinson's DBS surgery to be performed in the STN region Exclusion Criteria: Patients with advanced cognitive impairment Patients with pulmonary, neurological and orthopedic diseases affecting functionalities Pregnancy Patients in whom the stimulation was canceled due to infection after surgery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deran Oskay, PhD
Phone
0312 2162600
Ext
2162627
Email
deranoskay@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bircan Yucekaya, MSc
Phone
03262455516
Ext
15514
Email
bircanyucekaya@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deran Oskay, PhD
Organizational Affiliation
Gazi University Faculty of Health Science Department of Physical Therapy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bircan Yucekaya, MSc
Organizational Affiliation
Hatay Mustafa Kemal University School of Physical Therapy and Rehabilitation
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Atilla Yılmaz, Med. Dr
Organizational Affiliation
Hatay Mustafa Kemal University Department of Neurosurgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hatay Mustafa Kemal University
City
Antakya
State/Province
Hatay
ZIP/Postal Code
30100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bircan Yucekaya, MSc
Phone
+903262455516
Ext
15514
Email
bircanyucekaya@hotmail.com
First Name & Middle Initial & Last Name & Degree
Deran Oskay, PhD
Phone
312 2162600
Ext
2162627
Email
deranoskay@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17130410
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.
Results Reference
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PubMed Identifier
20022689
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.
Results Reference
background
PubMed Identifier
21841525
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.
Results Reference
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The Effects Of DBS Of Subthalamıc Nucleus On Functionality In Patıents With Parkinson's Disease: Short-Term Results

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