The Effect of Deep Brain Stimulation on Facial Expressions.

NCT ID: NCT03558568

Last Updated: 2019-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-12-01

Brief Summary

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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

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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

Conditions

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Parkinson

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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DBS off

Group Type ACTIVE_COMPARATOR

Deep Brain Stimulation

Intervention Type DEVICE

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

DBS on 60 Hz.

Group Type ACTIVE_COMPARATOR

Deep Brain Stimulation

Intervention Type DEVICE

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

DBS on 99 Hz.

Group Type ACTIVE_COMPARATOR

Deep Brain Stimulation

Intervention Type DEVICE

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

DBS on 130 Hz.

Group Type ACTIVE_COMPARATOR

Deep Brain Stimulation

Intervention Type DEVICE

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

DBS on 230 Hz.

Group Type ACTIVE_COMPARATOR

Deep Brain Stimulation

Intervention Type DEVICE

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

Interventions

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Deep Brain Stimulation

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

Intervention Type DEVICE

Other Intervention Names

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Vercise Activa PC

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mustafa Kemal University

OTHER

Sponsor Role lead

Responsible Party

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Atilla YILMAZ

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Atilla YILMAZ

Hatay, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Atilla YILMAZ

Role: CONTACT

+905322253991

Facility Contacts

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Atilla YILMAZ

Role: primary

+905322253991

Role: backup

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id

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