Efficacy of a Non-invasive Device for Alleviation of Parkinson's Disease Symptoms
NCT ID: NCT02722824
Last Updated: 2017-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2015-11-30
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Placebo
Wearable stimulators will be placed on the patients and controls without stimulation for 20 minutes
Placebo
Active Stimulation
Instrinsic auricular muscles will be stimulated for 20 minutes
Electro-stimulation
Sham
An area out of the instrinsic auricular muscles region will be stimulated with the same parameters of the active group for 20 minutes
Electro-stimulation
Passive Control
Only the electrodes of the wearable stimulators will be inserted but there will not be electrostimulation for 20 minutes
No interventions assigned to this group
Interventions
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Electro-stimulation
Placebo
Eligibility Criteria
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Inclusion Criteria
* H\&Y Stage \>= 2
* Existing bradykinesia symptoms
* Existence of one of the symptoms below
* Resting Tremor
* Rigidity
* Walking disorder
Exclusion Criteria
* Psychiatric diagnosis
* Irregular heart/respiration rate
* Pregnancy
* Alcohol consumption
* Cardiovascular disease history
* Wearing an electro-active prosthesis
* Brain surgery history
* Ongoing TENS/PENS therapy
18 Years
ALL
No
Sponsors
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Istanbul University
OTHER
Koç University
OTHER
Responsible Party
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Yasemin Gürsoy Özdemir
Professor
Locations
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Istanbul University
Istanbul, , Turkey (Türkiye)
Koc University Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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Par-01
Identifier Type: -
Identifier Source: org_study_id
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