CClinicalTrials.gg
Status unknownNCT03558568STN-DBSUpdated Mar 14, 2019

The Effect of Deep Brain Stimulation on Facial Expressions.

An interventional study of Deep Brain Stimulation in Parkinson, sponsored by Mustafa Kemal University. Status unknown at 1 site in Turkey. Open to participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-14.

Sponsored by Mustafa Kemal University · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Non-randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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

Read the 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
02

Conditions studied

  • Parkinson

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Keywords

  • Parkinson's Disease
  • Deep Brain Stimulation
  • Subthalamic Nucleus
  • DBS
  • STN
  • Face
  • Facial expressions
  • Parkinson
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's planned enrollment of 18 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Mustafa Kemal University is the lead sponsor of 71 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
18 participants (estimated)

Study arms

  • Active comparator
    DBS off

    Device: Deep Brain Stimulation

  • Active comparator
    DBS on 60 Hz.

    Device: Deep Brain Stimulation

  • Active comparator
    DBS on 99 Hz.

    Device: Deep Brain Stimulation

  • Active comparator
    DBS on 130 Hz.

    Device: Deep Brain Stimulation

  • Active comparator
    DBS on 230 Hz.

    Device: Deep Brain Stimulation

Interventions

  • DeviceDeep Brain Stimulation

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

    Also known as: Vercise, Activa PC

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — The results will be shared

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03558568
Lead sponsor
Mustafa Kemal University
Responsible party
Atilla YILMAZ (Assistant Professor, Mustafa Kemal University) — Principal investigator
First posted
Jun 15, 2018
Start date
May 1, 2018
Primary completion
Aug 12, 2019 (estimated)
Completion
Dec 1, 2019 (estimated)
Last update
Mar 14, 2019

Study contacts

Atilla YILMAZ
Contact
atillayilmaz@hotmail.com
+905322253991

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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