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

NCT ID: NCT03797976

Last Updated: 2019-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson Disease Surgery Respiration; Decreased Muscle Weakness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Parkinson's Disease Group

MIP and MEP Respiratory Function Test Strength Test

Group Type EXPERIMENTAL

MIP and MEP

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MIP and MEP

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Respiratory Function Test Muscle Test

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mustafa Kemal University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Bircan Yücekaya

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Deran Oskay, PhD

Role: STUDY_DIRECTOR

Gazi University Faculty of Health Science Department of Physical Therapy

Bircan Yucekaya, MSc

Role: STUDY_CHAIR

Hatay Mustafa Kemal University School of Physical Therapy and Rehabilitation

Atilla Yılmaz, Med. Dr

Role: PRINCIPAL_INVESTIGATOR

Hatay Mustafa Kemal University Department of Neurosurgery

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hatay Mustafa Kemal University

Antakya, Hatay, Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Deran Oskay, PhD

Role: CONTACT

0312 2162600 ext. 2162627

Bircan Yucekaya, MSc

Role: CONTACT

03262455516 ext. 15514

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Bircan Yucekaya, MSc

Role: primary

+903262455516 ext. 15514

Deran Oskay, PhD

Role: backup

312 2162600 ext. 2162627

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 17130410 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20022689 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21841525 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Hatay Mustafa Kemal U 1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Anesthesia for Deep Brain Stimulation
NCT01789385 COMPLETED PHASE4
Deep Brain Stimulation and Parkinson's Disease
NCT02795663 COMPLETED EARLY_PHASE1