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Clinical Trials/NCT03797976
NCT03797976
Unknown
N/A

The Effects Of Deep Brain Stimulation Of Subthalamıc Nucleus On Pulmonary Function Tests and Functionality In Patıents With Parkinson's Disease: Short Term Results

Mustafa Kemal University1 site in 1 country10 target enrollmentJanuary 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Mustafa Kemal University
Enrollment
10
Locations
1
Primary Endpoint
Functional exercise capacity
Last Updated
7 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
December 30, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bircan Yücekaya

Lecturer

Mustafa Kemal University

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.

Outcomes

Primary Outcomes

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

6 minute walking test

Secondary Outcomes

  • Muscle strength(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)
  • Grip Test (Peripheral muscle strength)(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)
  • Pulmonary functions(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)
  • Inspiratory and expiratory muscle strength (MIP, MEP)(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)

Study Sites (1)

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