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

NCT03797976 | Unknown DMC

• 1 other identifier: Hatay Mustafa Kemal U 1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Surgery; Respiration; Decreased; Muscle Weakness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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

Study Arms (1)

Parkinson's Disease Group

EXPERIMENTAL

MIP and MEP Respiratory Function Test Strength Test

Device: MIP and MEP

Interventions

MIP and MEP DEVICE

Pre-op, Post-op of, 1 month after surgery, 3 months after surgery

Also known as: Respiratory Function Test, Muscle Test

Parkinson's Disease Group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mustafa Kemal University: lead

Study Sites (1)

Hatay Mustafa Kemal University

Antakya, Hatay, 30100, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Respiratory Insufficiency; Muscle Weakness

Interventions

Maximal Respiratory Pressures; Respiratory Function Tests

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Respiration Disorders; Respiratory Tract Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Deran Oskay, PhD

  Gazi University Faculty of Health Science Department of Physical Therapy

  STUDY DIRECTOR

• Bircan Yucekaya, MSc

  Hatay Mustafa Kemal University School of Physical Therapy and Rehabilitation

  STUDY CHAIR

• Atilla Yılmaz, Med. Dr

  Hatay Mustafa Kemal University Department of Neurosurgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deran Oskay, PhD

CONTACT

0312 2162600; deranoskay@yahoo.com

Bircan Yucekaya, MSc

CONTACT

03262455516; bircanyucekaya@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: January 9, 2019
• Study Start: January 1, 2018
• Primary Completion: September 30, 2019
• Study Completion: December 30, 2019
• Last Updated: March 15, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)