Efficacy of a Non-invasive Device for Alleviation of Parkinson's Disease Symptoms

NCT ID: NCT02722824

Last Updated: 2017-07-26

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-06-30

Brief Summary

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Investigation efficacy of a non-invasive wearable electrostimulator device where the supplementary motor area, premotor area and/or subthalamic nucleus are stimulated bilaterally and extracranially.

Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Wearable stimulators will be placed on the patients and controls without stimulation for 20 minutes

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Active Stimulation

Instrinsic auricular muscles will be stimulated for 20 minutes

Group Type EXPERIMENTAL

Electro-stimulation

Intervention Type DEVICE

Sham

An area out of the instrinsic auricular muscles region will be stimulated with the same parameters of the active group for 20 minutes

Group Type SHAM_COMPARATOR

Electro-stimulation

Intervention Type DEVICE

Passive Control

Only the electrodes of the wearable stimulators will be inserted but there will not be electrostimulation for 20 minutes

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Electro-stimulation

Intervention Type DEVICE

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Parkinson's Disease
* H\&Y Stage \>= 2
* Existing bradykinesia symptoms
* Existence of one of the symptoms below
* Resting Tremor
* Rigidity
* Walking disorder

Exclusion Criteria

* Cardiac Pacemaker
* Psychiatric diagnosis
* Irregular heart/respiration rate
* Pregnancy
* Alcohol consumption
* Cardiovascular disease history
* Wearing an electro-active prosthesis
* Brain surgery history
* Ongoing TENS/PENS therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role collaborator

Koç University

OTHER

Sponsor Role lead

Responsible Party

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Yasemin Gürsoy Özdemir

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istanbul University

Istanbul, , Turkey (Türkiye)

Site Status

Koc University Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Par-01

Identifier Type: -

Identifier Source: org_study_id

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