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

July 24, 2017 updated by: Yasemin Gürsoy Özdemir, Koç University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Istanbul University
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 >= 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

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Wearable stimulators will be placed on the patients and controls without stimulation for 20 minutes
Other: Placebo
Experimental: Active Stimulation
Instrinsic auricular muscles will be stimulated for 20 minutes
Device: Electro-stimulation
Sham Comparator: Sham
An area out of the instrinsic auricular muscles region will be stimulated with the same parameters of the active group for 20 minutes
Device: Electro-stimulation
No Intervention: Passive Control
Only the electrodes of the wearable stimulators will be inserted but there will not be electrostimulation for 20 minutes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in the UPDRS Motor Score (Part III)
Time Frame: 10 minutes after the stimulation is initiated.
Evaluation of patients' disease level with UPDRS examination at the middle of the stimulation
10 minutes after the stimulation is initiated.
Change in the UPDRS Motor Score (Part III)
Time Frame: 30 minutes after the stimulation is terminated.
Evaluation of patients' disease level with UPDRS examination 30 minutes after the stimulation is terminated.
30 minutes after the stimulation is terminated.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in the gait and balance parameters (cadence)
Time Frame: 10 minutes after the stimulation is initiated.
cadence
10 minutes after the stimulation is initiated.
Change in the gait and balance parameters (Stride length)
Time Frame: 10 minutes after the stimulation is initiated.
Stride length in meters
10 minutes after the stimulation is initiated.
Change in the gait and balance parameters (Stride velocity)
Time Frame: 10 minutes after the stimulation is initiated.
Stride velocity in m/s
10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Time Frame: 10 minutes after the stimulation is initiated.
Arm Swing Rate
10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Time Frame: 10 minutes after the stimulation is initiated.
Arm Range of Motion
10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Time Frame: 10 minutes after the stimulation is initiated.
Sit to Stand Duration
10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Time Frame: 10 minutes after the stimulation is initiated.
Sit to Stand Peak Trunk Velocity
10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Time Frame: 10 minutes after the stimulation is initiated.
Sit to Stand Peak Trunk Angle
10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Time Frame: 10 minutes after the stimulation is initiated.
Leg Swing Rate
10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Time Frame: 10 minutes after the stimulation is initiated.
Leg Range of Motion
10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Time Frame: 10 minutes after the stimulation is initiated.
Turn to Sit Peak Turn Velocity
10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Time Frame: 10 minutes after the stimulation is initiated.
Turn-to-Sit Trunk Range of Motion in Sagittal Plane
10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Time Frame: 10 minutes after the stimulation is initiated.
Knee Range of Motion
10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Time Frame: 10 minutes after the stimulation is initiated.
Trunk Joint Angles
10 minutes after the stimulation is initiated.
Change in the gait and balance parameters (cadence)
Time Frame: 30 minutes after the stimulation is terminated.
cadence
30 minutes after the stimulation is terminated.
Change in the gait and balance parameters (Stride length)
Time Frame: 30 minutes after the stimulation is terminated.
Stride length in meters
30 minutes after the stimulation is terminated.
Change in the gait and balance parameters (Stride velocity)
Time Frame: 30 minutes after the stimulation is terminated.
Stride velocity in m/s
30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Time Frame: 30 minutes after the stimulation is terminated.
Arm Swing Rate
30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Time Frame: 30 minutes after the stimulation is terminated.
Arm Range of Motion
30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Time Frame: 30 minutes after the stimulation is terminated.
Sit to Stand Duration
30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Time Frame: 30 minutes after the stimulation is terminated.
Sit to Stand Peak Trunk Velocity
30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Time Frame: 30 minutes after the stimulation is terminated.
Sit to Stand Peak Trunk Angle
30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Time Frame: 30 minutes after the stimulation is terminated.
Leg Swing Rate
30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Time Frame: 30 minutes after the stimulation is terminated.
Leg Range of Motion
30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Time Frame: 30 minutes after the stimulation is terminated.
Turn-to-Sit Peak Turn Velocity
30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Time Frame: 30 minutes after the stimulation is terminated.
Turn-to-Sit Trunk Range of Motion
30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Time Frame: 30 minutes after the stimulation is terminated.
Knee Range of Motion
30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Time Frame: 30 minutes after the stimulation is terminated.
Trunk Joint Angles
30 minutes after the stimulation is terminated.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Koç University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Istanbul University

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Par-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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