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

Primary Purpose

Parkinson

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Deep Brain Stimulation
Sponsored by
Mustafa Kemal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson focused on measuring Parkinson's Disease, Deep Brain Stimulation, Subthalamic Nucleus, DBS, STN, Face, Facial expressions, Parkinson

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Atilla YILMAZRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

DBS off

DBS on 60 Hz.

DBS on 99 Hz.

DBS on 130 Hz.

DBS on 230 Hz.

Arm Description

Outcomes

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.
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 Outcome Measures

Full Information

First Posted
May 28, 2018
Last Updated
March 13, 2019
Sponsor
Mustafa Kemal University
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1. Study Identification

Unique Protocol Identification Number
NCT03558568
Brief Title
The Effect of Deep Brain Stimulation on Facial Expressions.
Acronym
STN-DBS
Official Title
The Effect of Subthalamic Nucleus Deep Brain Stimulation on Facial Expressions in Parkinson's Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
August 12, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mustafa Kemal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson
Keywords
Parkinson's Disease, Deep Brain Stimulation, Subthalamic Nucleus, DBS, STN, Face, Facial expressions, Parkinson

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DBS off
Arm Type
Active Comparator
Arm Title
DBS on 60 Hz.
Arm Type
Active Comparator
Arm Title
DBS on 99 Hz.
Arm Type
Active Comparator
Arm Title
DBS on 130 Hz.
Arm Type
Active Comparator
Arm Title
DBS on 230 Hz.
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Deep Brain Stimulation
Other Intervention Name(s)
Vercise, Activa PC
Intervention Description
Deep Brain Stimulation is an established surgical method for Parkinson's Disease.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Atilla YILMAZ
Phone
+905322253991
Email
atillayilmaz@hotmail.com
Facility Information:
Facility Name
Atilla YILMAZ
City
Hatay
ZIP/Postal Code
31070
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atilla YILMAZ
Phone
+905322253991
Email
atillayilmaz@hotmail.com
Email
atillayilmaz@mku.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The results will be shared
IPD Sharing URL
http://www.supporttoscience.com

Learn more about this trial

The Effect of Deep Brain Stimulation on Facial Expressions.

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