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

Mustafa Kemal University

Status: Unknown

Conditions: Parkinson

Treatments: Device: Deep Brain Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03558568

1

Details and patient eligibility

About

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

Full 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

Enrollment: 18 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 5 patient groups

DBS off

Active Comparator group

Treatment:

Device: Deep Brain Stimulation

DBS on 60 Hz.

Active Comparator group

Treatment:

Device: Deep Brain Stimulation

DBS on 99 Hz.

Active Comparator group

Treatment:

Device: Deep Brain Stimulation

DBS on 130 Hz.

Active Comparator group

Treatment:

Device: Deep Brain Stimulation

DBS on 230 Hz.

Active Comparator group

Treatment:

Device: Deep Brain Stimulation