The Effect of Deep Brain Stimulation on Facial Expressions. (STN-DBS)
The Effect of Subthalamic Nucleus Deep Brain Stimulation on Facial Expressions in Parkinson's Disease.
Study Overview
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hatay, Turkey, 31070
- Recruiting
- Atilla YILMAZ
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Contact:
- Atilla YILMAZ
- Phone Number: +905322253991
- Email: atillayilmaz@hotmail.com
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Contact:
- Email: atillayilmaz@mku.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: DBS off
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Deep Brain Stimulation is an established surgical method for Parkinson's Disease.
Other Names:
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Active Comparator: DBS on 60 Hz.
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Deep Brain Stimulation is an established surgical method for Parkinson's Disease.
Other Names:
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Active Comparator: DBS on 99 Hz.
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Deep Brain Stimulation is an established surgical method for Parkinson's Disease.
Other Names:
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Active Comparator: DBS on 130 Hz.
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Deep Brain Stimulation is an established surgical method for Parkinson's Disease.
Other Names:
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Active Comparator: DBS on 230 Hz.
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Deep Brain Stimulation is an established surgical method for Parkinson's Disease.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1 (Mobile Health and Wellness Program)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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