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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Electro-stimulation
Placebo
Sponsored by
Koç University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring motor symptoms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul University
  • Koc University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Sham Comparator

No Intervention

Arm Label

Placebo

Active Stimulation

Sham

Passive Control

Arm Description

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

Instrinsic auricular muscles will be stimulated for 20 minutes

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

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

Outcomes

Primary Outcome Measures

Change in the UPDRS Motor Score (Part III)
Evaluation of patients' disease level with UPDRS examination at the middle of the stimulation
Change in the UPDRS Motor Score (Part III)
Evaluation of patients' disease level with UPDRS examination 30 minutes after the stimulation is terminated.

Secondary Outcome Measures

Change in the gait and balance parameters (cadence)
cadence
Change in the gait and balance parameters (Stride length)
Stride length in meters
Change in the gait and balance parameters (Stride velocity)
Stride velocity in m/s
Change in the gait and balance parameters
Arm Swing Rate
Change in the gait and balance parameters
Arm Range of Motion
Change in the gait and balance parameters
Sit to Stand Duration
Change in the gait and balance parameters
Sit to Stand Peak Trunk Velocity
Change in the gait and balance parameters
Sit to Stand Peak Trunk Angle
Change in the gait and balance parameters
Leg Swing Rate
Change in the gait and balance parameters
Leg Range of Motion
Change in the gait and balance parameters
Turn to Sit Peak Turn Velocity
Change in the gait and balance parameters
Turn-to-Sit Trunk Range of Motion in Sagittal Plane
Change in the gait and balance parameters
Knee Range of Motion
Change in the gait and balance parameters
Trunk Joint Angles
Change in the gait and balance parameters (cadence)
cadence
Change in the gait and balance parameters (Stride length)
Stride length in meters
Change in the gait and balance parameters (Stride velocity)
Stride velocity in m/s
Change in the gait and balance parameters
Arm Swing Rate
Change in the gait and balance parameters
Arm Range of Motion
Change in the gait and balance parameters
Sit to Stand Duration
Change in the gait and balance parameters
Sit to Stand Peak Trunk Velocity
Change in the gait and balance parameters
Sit to Stand Peak Trunk Angle
Change in the gait and balance parameters
Leg Swing Rate
Change in the gait and balance parameters
Leg Range of Motion
Change in the gait and balance parameters
Turn-to-Sit Peak Turn Velocity
Change in the gait and balance parameters
Turn-to-Sit Trunk Range of Motion
Change in the gait and balance parameters
Knee Range of Motion
Change in the gait and balance parameters
Trunk Joint Angles

Full Information

First Posted
March 6, 2016
Last Updated
July 24, 2017
Sponsor
Koç University
Collaborators
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT02722824
Brief Title
Efficacy of a Non-invasive Device for Alleviation of Parkinson's Disease Symptoms
Official Title
Efficacy Investigation of a Non-invasive Wearable Electrostimulation Device for Alleviation of Parkinson's Disease Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Koç University
Collaborators
Istanbul University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
motor symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Wearable stimulators will be placed on the patients and controls without stimulation for 20 minutes
Arm Title
Active Stimulation
Arm Type
Experimental
Arm Description
Instrinsic auricular muscles will be stimulated for 20 minutes
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
An area out of the instrinsic auricular muscles region will be stimulated with the same parameters of the active group for 20 minutes
Arm Title
Passive Control
Arm Type
No Intervention
Arm Description
Only the electrodes of the wearable stimulators will be inserted but there will not be electrostimulation for 20 minutes
Intervention Type
Device
Intervention Name(s)
Electro-stimulation
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in the UPDRS Motor Score (Part III)
Description
Evaluation of patients' disease level with UPDRS examination at the middle of the stimulation
Time Frame
10 minutes after the stimulation is initiated.
Title
Change in the UPDRS Motor Score (Part III)
Description
Evaluation of patients' disease level with UPDRS examination 30 minutes after the stimulation is terminated.
Time Frame
30 minutes after the stimulation is terminated.
Secondary Outcome Measure Information:
Title
Change in the gait and balance parameters (cadence)
Description
cadence
Time Frame
10 minutes after the stimulation is initiated.
Title
Change in the gait and balance parameters (Stride length)
Description
Stride length in meters
Time Frame
10 minutes after the stimulation is initiated.
Title
Change in the gait and balance parameters (Stride velocity)
Description
Stride velocity in m/s
Time Frame
10 minutes after the stimulation is initiated.
Title
Change in the gait and balance parameters
Description
Arm Swing Rate
Time Frame
10 minutes after the stimulation is initiated.
Title
Change in the gait and balance parameters
Description
Arm Range of Motion
Time Frame
10 minutes after the stimulation is initiated.
Title
Change in the gait and balance parameters
Description
Sit to Stand Duration
Time Frame
10 minutes after the stimulation is initiated.
Title
Change in the gait and balance parameters
Description
Sit to Stand Peak Trunk Velocity
Time Frame
10 minutes after the stimulation is initiated.
Title
Change in the gait and balance parameters
Description
Sit to Stand Peak Trunk Angle
Time Frame
10 minutes after the stimulation is initiated.
Title
Change in the gait and balance parameters
Description
Leg Swing Rate
Time Frame
10 minutes after the stimulation is initiated.
Title
Change in the gait and balance parameters
Description
Leg Range of Motion
Time Frame
10 minutes after the stimulation is initiated.
Title
Change in the gait and balance parameters
Description
Turn to Sit Peak Turn Velocity
Time Frame
10 minutes after the stimulation is initiated.
Title
Change in the gait and balance parameters
Description
Turn-to-Sit Trunk Range of Motion in Sagittal Plane
Time Frame
10 minutes after the stimulation is initiated.
Title
Change in the gait and balance parameters
Description
Knee Range of Motion
Time Frame
10 minutes after the stimulation is initiated.
Title
Change in the gait and balance parameters
Description
Trunk Joint Angles
Time Frame
10 minutes after the stimulation is initiated.
Title
Change in the gait and balance parameters (cadence)
Description
cadence
Time Frame
30 minutes after the stimulation is terminated.
Title
Change in the gait and balance parameters (Stride length)
Description
Stride length in meters
Time Frame
30 minutes after the stimulation is terminated.
Title
Change in the gait and balance parameters (Stride velocity)
Description
Stride velocity in m/s
Time Frame
30 minutes after the stimulation is terminated.
Title
Change in the gait and balance parameters
Description
Arm Swing Rate
Time Frame
30 minutes after the stimulation is terminated.
Title
Change in the gait and balance parameters
Description
Arm Range of Motion
Time Frame
30 minutes after the stimulation is terminated.
Title
Change in the gait and balance parameters
Description
Sit to Stand Duration
Time Frame
30 minutes after the stimulation is terminated.
Title
Change in the gait and balance parameters
Description
Sit to Stand Peak Trunk Velocity
Time Frame
30 minutes after the stimulation is terminated.
Title
Change in the gait and balance parameters
Description
Sit to Stand Peak Trunk Angle
Time Frame
30 minutes after the stimulation is terminated.
Title
Change in the gait and balance parameters
Description
Leg Swing Rate
Time Frame
30 minutes after the stimulation is terminated.
Title
Change in the gait and balance parameters
Description
Leg Range of Motion
Time Frame
30 minutes after the stimulation is terminated.
Title
Change in the gait and balance parameters
Description
Turn-to-Sit Peak Turn Velocity
Time Frame
30 minutes after the stimulation is terminated.
Title
Change in the gait and balance parameters
Description
Turn-to-Sit Trunk Range of Motion
Time Frame
30 minutes after the stimulation is terminated.
Title
Change in the gait and balance parameters
Description
Knee Range of Motion
Time Frame
30 minutes after the stimulation is terminated.
Title
Change in the gait and balance parameters
Description
Trunk Joint Angles
Time Frame
30 minutes after the stimulation is terminated.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Istanbul University
City
İstanbul
Country
Turkey
Facility Name
Koc University Hospital
City
İstanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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