The Effect of Deep Brain Stimulation on Facial Expressions.

NCT03558568 | Unknown FDA Device

• 1 other identifier: 1
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Parkinson

Keywords

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

Outcome Measures

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.

  3 months

Study Arms (5)

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

Interventions

Deep Brain Stimulation DEVICE

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

Also known as: Vercise, Activa PC

DBS off; DBS on 130 Hz.; DBS on 230 Hz.; DBS on 60 Hz.; DBS on 99 Hz.

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mustafa Kemal University: lead

Study Sites (1)

Atilla YILMAZ

Hatay, 31070, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Facies; Facial Expression

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nonverbal Communication; Communication; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Central Study Contacts

Atilla YILMAZ

CONTACT

+905322253991; atillayilmaz@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 28, 2018
• First Posted: June 15, 2018
• Study Start: May 1, 2018
• Primary Completion: August 12, 2019
• Study Completion: December 1, 2019
• Last Updated: March 14, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)