Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-25 @ 3:15 PM
Study NCT ID:
NCT03558568
Status:
UNKNOWN
Last Update Posted:
2019-03-14
First Post:
2018-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Deep Brain Stimulation on Facial Expressions.
Sponsor:
Mustafa Kemal University
Organization:
Study Overview
Official Title:
The Effect of Subthalamic Nucleus Deep Brain Stimulation on Facial Expressions in Parkinson's Disease.
Status:
UNKNOWN
Status Verified Date:
2019-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STN-DBS
Brief Summary:
Whether Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS), a treatment commonly used to ameliorate the motor symptoms of Parkinson's disease (PD), affects on facial expressions is unclear. The purpose of this study was to investigate the potential effects of DBS and different frequencies on facial expressions of PD patients by volunteers via a web site: http://www.supporttoscience.com
Detailed Description:
Parkinson's disease (PD) is the second most frequent progressive neuro-degenerative disease with a worldwide prevalence of 4-6 million and the mask face is an important and also troublesome sign of PD. Deep Brain Stimulation (DBS) surgery can be a viable option which has recently emerged and been accepted as a useful surgical method for PD. Standard DBS targets include Subthalamic Nucleus (STN) and Globus Pallidus Internus (GPi). Although the STN-DBS application is known to have favorable effects on motor and non-motor symptoms of PD, there is a lack information about the effect on facial expressions of PD patients. Our aim is to analyze the effect of the STN-DBS stimulation and different frequencies on the facial expressions of PD patients.
The study initially recruited 18 patients with idiopathic PD who underwent DBS surgery for movement disorders caused by PD at Mustafa Kemal University Medical Faculty Neurosurgery Department.
Inclusion criteria:
* Idiopathic PD responsive to L-Dopa treatment,
* Between 40-75 years of age,
* Having received bilateral STN DBS surgery at least six months prior to the investigation to ensure stable stimulation parameters,
* Mentally normal patients that could understand and respond to a directives. The evaluation will be made by the face photos of the patients. The face photos for the expressions including \[normal\], \[sad\], \[happy\], and \[angry\] were obtained at frequencies including 130 Hz, 60 Hz, 99 Hz, 230 Hz and off-stimulation. The face photos will evaluate by the software and by the volunteers with the aim of a website: http://www.supporttoscience.com
The study initially recruited 18 patients with idiopathic PD who underwent DBS surgery for movement disorders caused by PD at Mustafa Kemal University Medical Faculty Neurosurgery Department.
Inclusion criteria:
* Idiopathic PD responsive to L-Dopa treatment,
* Between 40-75 years of age,
* Having received bilateral STN DBS surgery at least six months prior to the investigation to ensure stable stimulation parameters,
* Mentally normal patients that could understand and respond to a directives. The evaluation will be made by the face photos of the patients. The face photos for the expressions including \[normal\], \[sad\], \[happy\], and \[angry\] were obtained at frequencies including 130 Hz, 60 Hz, 99 Hz, 230 Hz and off-stimulation. The face photos will evaluate by the software and by the volunteers with the aim of a website: http://www.supporttoscience.com
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: