STN-DBS: The Effect of Deep Brain Stimulation on Facial Expressions.

Sponsor

Mustafa Kemal University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03558568

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Parkinson	Device: Deep Brain Stimulation	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

The Effect of Subthalamic Nucleus Deep Brain Stimulation on Facial Expressions in Parkinson's Disease.

Actual Study Start Date :

May 1, 2018

Anticipated Primary Completion Date :

Aug 12, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: DBS off	Device: Deep Brain Stimulation Deep Brain Stimulation is an established surgical method for Parkinson's Disease. Other Names: Vercise Activa PC
Active Comparator: DBS on 60 Hz.	Device: Deep Brain Stimulation Deep Brain Stimulation is an established surgical method for Parkinson's Disease. Other Names: Vercise Activa PC
Active Comparator: DBS on 99 Hz.	Device: Deep Brain Stimulation Deep Brain Stimulation is an established surgical method for Parkinson's Disease. Other Names: Vercise Activa PC
Active Comparator: DBS on 130 Hz.	Device: Deep Brain Stimulation Deep Brain Stimulation is an established surgical method for Parkinson's Disease. Other Names: Vercise Activa PC
Active Comparator: DBS on 230 Hz.	Device: Deep Brain Stimulation Deep Brain Stimulation is an established surgical method for Parkinson's Disease. Other Names: Vercise Activa PC

Outcome Measures

Primary Outcome Measures

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. [3 months]
The evaluation of patients photos (in different frequencies and when stimulation off status) will be analyzed by volunteers via a website, then the results will be compare and evaluate by statistical analysis. The results will give us an opinion about these: The effect of Deep Brain Stimulation on Parkinsonians patients facial expression and which frequency setting is better for facial expression.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.