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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03797976
• Other study ID #: Hatay Mustafa Kemal U 1
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: March 2019
• Source: Mustafa Kemal University
• Contact: Deran Oskay, PhD
• Phone: 0312 2162600
• Email: deranoskay[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Weakness
• Paresis
• Parkinson Disease
• Respiration; Decreased
• Surgery

Intervention

Device:
• MIP and MEP
Pre-op, Post-op of, 1 month after surgery, 3 months after surgery

Locations

Country	Name	City	State
Turkey	Hatay Mustafa Kemal University	Antakya	Hatay

Sponsors (1)

Lead Sponsor	Collaborator
Mustafa Kemal University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional exercise capacity	6 minute walking test	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	Pulmonary functions	Spirometry	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
Secondary	Inspiratory and expiratory muscle strength (MIP, MEP)	Mouth pressure device	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
Secondary	Muscle strength	Muscle Testing Device (N)	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
Secondary	Grip Test (Peripheral muscle strength)	Hand Held Dynamometer (kgf)	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