Clinical trial NCT03797976: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Surgery
Respiration; Decreased
Muscle Weakness
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
First posted: 2019-01-09
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

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.

Primary outcomes:
measure: Functional exercise capacity
timeFrame: 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 outcomes:
measure: Pulmonary functions
timeFrame: 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
measure: Inspiratory and expiratory muscle strength (MIP, MEP)
timeFrame: 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
measure: Muscle strength
timeFrame: 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
measure: Grip Test (Peripheral muscle strength)
timeFrame: 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
Other outcomes:
Locations:
city: Antakya
country: Turkey
facility: Hatay Mustafa Kemal University
state: Hatay
Study officials:
affiliation: Gazi University Faculty of Health Science Department of Physical Therapy
name: Deran Oskay, PhD
role: STUDY_DIRECTOR
affiliation: Hatay Mustafa Kemal University School of Physical Therapy and Rehabilitation
name: Bircan Yucekaya, MSc
role: STUDY_CHAIR
affiliation: Hatay Mustafa Kemal University Department of Neurosurgery
name: Atilla Yılmaz, Med. Dr
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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.