ParkinsonSTN-DBSNCT03558568
The Effect of Deep Brain Stimulation on Facial Expressions.
A study testing Deep Brain Stimulation in people with Parkinson, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2018to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Atilla YILMAZ
Hatay, 31070
Atilla YILMAZ, +905322253991, atillayilmaz@hotmail.com
atillayilmaz@mku.edu.tr
About this study
Official title: The Effect of Subthalamic Nucleus Deep Brain Stimulation on Facial Expressions in Parkinson's Disease.
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
- Conditions
- Parkinson
- Being tested
- Deep Brain Stimulation
- Keywords
- Parkinson's Disease, Deep Brain Stimulation, Subthalamic Nucleus, DBS, STN, Face, Facial expressions, Parkinson
- Medical subject headings
- Parkinson Disease, Facies, Facial Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationDevice
Also called Vercise, Activa PC
Deep Brain Stimulation is an established surgical method for Parkinson's Disease.
| Study group | Role | What they receive |
|---|---|---|
| DBS off | Active comparator | Not described Receives: Device: Deep Brain Stimulation |
| DBS on 60 Hz. | Active comparator | Not described Receives: Device: Deep Brain Stimulation |
| DBS on 99 Hz. | Active comparator | Not described Receives: Device: Deep Brain Stimulation |
| DBS on 130 Hz. | Active comparator | Not described Receives: Device: Deep Brain Stimulation |
| DBS on 230 Hz. | Active comparator | Not described Receives: Device: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start1 May 2018
- Primary completion12 Aug 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParkinsonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atilla YILMAZ, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558568
- Sponsor's protocol ID
- 1
- Acronym
- STN-DBS
- Status last verified
- Mar 2019
- First submitted
- 28 May 2018
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The results will be shared
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Subthalamic Nucleus Deep Brain Stimulation on Facial Expressions in Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT03558568
- Acronym / sponsor ID
- STN-DBS / 1
- Conditions
- Parkinson
- Keywords
- Parkinson's Disease, Deep Brain Stimulation, Subthalamic Nucleus, DBS, STN, Face, Facial expressions, Parkinson
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 12 Aug 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 15 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- 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.
| Arm | Type | Receives |
|---|---|---|
| DBS off | Active comparator | Device: Deep Brain Stimulation |
| DBS on 60 Hz. | Active comparator | Device: Deep Brain Stimulation |
| DBS on 99 Hz. | Active comparator | Device: Deep Brain Stimulation |
| DBS on 130 Hz. | Active comparator | Device: Deep Brain Stimulation |
| DBS on 230 Hz. | Active comparator | Device: Deep Brain Stimulation |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Brain StimulationAlso: Vercise, Activa PCDeep Brain Stimulation is an established surgical method for Parkinson's Disease. | Device | DBS off, DBS on 130 Hz., DBS on 230 Hz., DBS on 60 Hz., DBS on 99 Hz. |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Individual participant dataSharing planned: Yes. The results will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation in people with Parkinson, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Atilla YILMAZ (+905322253991, atillayilmaz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2019.