The Effect of Deep Brain Stimulation on Facial Expressions.

Parkinson Clinical Trial

— STN-DBS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03558568
• Other study ID #: 1
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: March 2019
• Source: Mustafa Kemal University
• Contact: Atilla YILMAZ
• Phone: +905322253991
• Email: atillayilmaz[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: December 1, 2019
• Est. primary completion date: August 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson
• Parkinson Disease

Intervention

Device:
• Deep Brain Stimulation
Deep Brain Stimulation is an established surgical method for Parkinson's Disease.

Locations

Country	Name	City	State
Turkey	Atilla YILMAZ	Hatay

Sponsors (1)

Lead Sponsor	Collaborator
Mustafa Kemal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	3 months

External Links

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