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Clinical Trials/NCT03558568
NCT03558568UnknownNot Applicable

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

Mustafa Kemal University1 site in 1 country18 target enrollmentStarted: May 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
18
Locations
1
Primary Endpoint
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.

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to 75 Years (Adult, Older Adult)
Sex
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.

Arms & Interventions

DBS on 99 Hz.

Active Comparator

Intervention: Deep Brain Stimulation (Device)

DBS on 130 Hz.

Active Comparator

Intervention: Deep Brain Stimulation (Device)

DBS on 230 Hz.

Active Comparator

Intervention: Deep Brain Stimulation (Device)

DBS off

Active Comparator

Intervention: Deep Brain Stimulation (Device)

DBS on 60 Hz.

Active Comparator

Intervention: Deep Brain Stimulation (Device)

Outcomes

Primary Outcomes

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.

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Atilla YILMAZ

Assistant Professor

Mustafa Kemal University

Study Sites (1)

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