Effect of Auricular Stimulation on Locomotion in Patients With Parkinson's Disease

NCT ID: NCT03907007

Last Updated: 2020-03-10

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2018-05-01

Brief Summary

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The effect of auricular stimulation on the locomotion capability in patients with Parkinson's Disease was investigated.

Detailed Description

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Effect of the auricular stimulation as a supplementary and alternative usage to Levodopa was investigated in this study. Clinical data were collected through motion capture system while the participants performed the clinical task asked by the investigators.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sole Medication

Monitoring under current prescribed medication

Group Type NO_INTERVENTION

No interventions assigned to this group

Combined stimulation & medication

Concurrent usage of stimulation with the prescribed medication

Group Type ACTIVE_COMPARATOR

Percutaneous electrical nerve stimulation

Intervention Type DEVICE

Stimulation and medication at the same instant

Sole Stimulation

Alternating usage of stimulation to the prescribed medication

Group Type ACTIVE_COMPARATOR

Percutaneous electrical nerve stimulation

Intervention Type DEVICE

Stimulation is given without administering medication

Interventions

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Percutaneous electrical nerve stimulation

Stimulation and medication at the same instant

Intervention Type DEVICE

Percutaneous electrical nerve stimulation

Stimulation is given without administering medication

Intervention Type DEVICE

Other Intervention Names

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Stimulation & Medication Stimulation Only

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Parkinson's Disease
* H\&Y Stage \>= 1
* 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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Koç University

OTHER

Sponsor Role collaborator

Inventram

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yusuf O Cakmak, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Otago University

Locations

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Koc University Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Cakmak YO, Ozsoy B, Ertan S, Cakmak OO, Kiziltan G, Yapici-Eser H, Ozyaprak E, Olcer S, Urey H, Gursoy-Ozdemir Y. Intrinsic Auricular Muscle Zone Stimulation Improves Walking Parameters of Parkinson's Patients Faster Than Levodopa in the Motion Capture Analysis: A Pilot Study. Front Neurol. 2020 Oct 7;11:546123. doi: 10.3389/fneur.2020.546123. eCollection 2020.

Reference Type DERIVED
PMID: 33117256 (View on PubMed)

Other Identifiers

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Par-03

Identifier Type: -

Identifier Source: org_study_id

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