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

March 9, 2020 updated by: Inventram
The effect of auricular stimulation on the locomotion capability in patients with Parkinson's Disease was investigated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İstanbul, Turkey
        • Koc University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Sole Medication
Monitoring under current prescribed medication
ACTIVE_COMPARATOR: Combined stimulation & medication
Concurrent usage of stimulation with the prescribed medication
Device: Percutaneous electrical nerve stimulation
Stimulation and medication at the same instant
Other Names:
  • Stimulation & Medication
Device: Percutaneous electrical nerve stimulation
Stimulation is given without administering medication
Other Names:
  • Stimulation Only
ACTIVE_COMPARATOR: Sole Stimulation
Alternating usage of stimulation to the prescribed medication
Device: Percutaneous electrical nerve stimulation
Stimulation and medication at the same instant
Other Names:
  • Stimulation & Medication
Device: Percutaneous electrical nerve stimulation
Stimulation is given without administering medication
Other Names:
  • Stimulation Only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stride length [m]
Time Frame: Time Frame: Baseline
Measurement through motion capture system
Time Frame: Baseline
Stride length [m]
Time Frame: Time Frame: 20 minutes after stimulation is initiated
Measurement through motion capture system
Time Frame: 20 minutes after stimulation is initiated
Stride length [m]
Time Frame: Time Frame: 40 minutes after stimulation is initiated
Measurement through motion capture system
Time Frame: 40 minutes after stimulation is initiated
Stride length [m]
Time Frame: Time Frame: 60 minutes after stimulation is initiated
Measurement through motion capture system
Time Frame: 60 minutes after stimulation is initiated
Stride velocity [m/s]
Time Frame: Time Frame: Baseline
Measurement through motion capture system
Time Frame: Baseline
Stride velocity [m/s]
Time Frame: Time Frame: 20 minutes after stimulation is initiated
Measurement through motion capture system
Time Frame: 20 minutes after stimulation is initiated
Stride velocity [m/s]
Time Frame: Time Frame: 40 minutes after stimulation is initiated
Measurement through motion capture system
Time Frame: 40 minutes after stimulation is initiated
Stride velocity [m/s]
Time Frame: Time Frame: 60 minutes after stimulation is initiated
Measurement through motion capture system
Time Frame: 60 minutes after stimulation is initiated
Turning Velocity [deg/s]
Time Frame: Time Frame: Baseline
Measurement through motion capture system
Time Frame: Baseline
Turning Velocity [deg/s]
Time Frame: Time Frame: 20 minutes after stimulation is initiated
Measurement through motion capture system
Time Frame: 20 minutes after stimulation is initiated
Turning Velocity [deg/s]
Time Frame: Time Frame: 40 minutes after stimulation is initiated
Measurement through motion capture system
Time Frame: 40 minutes after stimulation is initiated
Turning Velocity [deg/s]
Time Frame: Time Frame: 60 minutes after stimulation is initiated
Measurement through motion capture system
Time Frame: 60 minutes after stimulation is initiated
Double Support Percentage during walking [%]
Time Frame: Time Frame: Baseline, 20 minutes, 40 minutes, 60 minutes
Measurement through motion capture system
Time Frame: Baseline, 20 minutes, 40 minutes, 60 minutes
Double Support Percentage during walking [%]
Time Frame: Time Frame: 20 minutes after stimulation is initiated
Measurement through motion capture system
Time Frame: 20 minutes after stimulation is initiated
Double Support Percentage during walking [%]
Time Frame: Time Frame: 40 minutes after stimulation is initiated
Measurement through motion capture system
Time Frame: 40 minutes after stimulation is initiated
Double Support Percentage during walking [%]
Time Frame: Time Frame: 60 minutes after stimulation is initiated
Measurement through motion capture system
Time Frame: 60 minutes after stimulation is initiated
Swing Phase Percentage during walking [%]
Time Frame: Time Frame: Baseline
Measurement through motion capture system
Time Frame: Baseline
Swing Phase Percentage during walking [%]
Time Frame: Time Frame: 20 minutes after stimulation is initiated
Measurement through motion capture system
Time Frame: 20 minutes after stimulation is initiated
Swing Phase Percentage during walking [%]
Time Frame: Time Frame: 40 minutes after stimulation is initiated
Measurement through motion capture system
Time Frame: 40 minutes after stimulation is initiated
Swing Phase Percentage during walking [%]
Time Frame: Time Frame: 60 minutes after stimulation is initiated
Measurement through motion capture system
Time Frame: 60 minutes after stimulation is initiated
Stance Phase Percentage during walking [%]
Time Frame: Time Frame: Baseline, 20 minutes, 40 minutes, 60 minutes
Measurement through motion capture system
Time Frame: Baseline, 20 minutes, 40 minutes, 60 minutes
Stance Phase Percentage during walking [%]
Time Frame: Time Frame: 20 minutes after stimulation is initiated
Measurement through motion capture system
Time Frame: 20 minutes after stimulation is initiated
Stance Phase Percentage during walking [%]
Time Frame: Time Frame: 40 minutes after stimulation is initiated
Measurement through motion capture system
Time Frame: 40 minutes after stimulation is initiated
Stance Phase Percentage during walking [%]
Time Frame: Time Frame: 60 minutes after stimulation is initiated
Measurement through motion capture system
Time Frame: 60 minutes after stimulation is initiated

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inventram

Collaborators

Koç University

Investigators

  • Principal Investigator: Yusuf O Cakmak, MD, PhD, Otago University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2017

Primary Completion (ACTUAL)

May 1, 2018

Study Completion (ACTUAL)

May 1, 2018

Study Registration Dates

First Submitted

March 29, 2019

First Submitted That Met QC Criteria

April 4, 2019

First Posted (ACTUAL)

April 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Par-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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