Clinical trial NCT03558568: The Effect of Deep Brain Stimulation on Facial Expressions.
Official title: The Effect of Subthalamic Nucleus Deep Brain Stimulation on Facial Expressions in Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson
Keywords: Parkinson's Disease
Deep Brain Stimulation
Subthalamic Nucleus
DBS
STN
Face
Facial expressions
Parkinson
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 18
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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

Eligibility criteria: Inclusion Criteria:

* Idiopathic PD responsive to L-Dopa treatment,
* Between 40-75 years of age,
* Having received bilateral STN DBS surgery at least one month prior to the investigation to ensure stable stimulation parameters,
* Mentally normal patients that could understand and respond to a questionnaire.

Exclusion Criteria:

* Above 75 years of age,
* Severe dementia,
* History of an additional neurologic disease,
* The presence of a disease, such as the facial paralysis, that could affect facial expressions,
* Having a wound on the face.

Primary outcomes:
measure: The effect of Deep brain stimulation on facial expressions will be analyzed by volunteers via a web site then the results will evaluate by statistical analyses.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hatay
country: Turkey
facility: Atilla YILMAZ
Study officials:
References: