search
Back to results

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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Percutaneous electrical nerve stimulation
Percutaneous electrical nerve stimulation
Sponsored by
Inventram
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Neurostimulator

Eligibility Criteria

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

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

Sites / Locations

  • Koc University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Sole Medication

Combined stimulation & medication

Sole Stimulation

Arm Description

Monitoring under current prescribed medication

Concurrent usage of stimulation with the prescribed medication

Alternating usage of stimulation to the prescribed medication

Outcomes

Primary Outcome Measures

Stride length [m]
Measurement through motion capture system
Stride length [m]
Measurement through motion capture system
Stride length [m]
Measurement through motion capture system
Stride length [m]
Measurement through motion capture system
Stride velocity [m/s]
Measurement through motion capture system
Stride velocity [m/s]
Measurement through motion capture system
Stride velocity [m/s]
Measurement through motion capture system
Stride velocity [m/s]
Measurement through motion capture system
Turning Velocity [deg/s]
Measurement through motion capture system
Turning Velocity [deg/s]
Measurement through motion capture system
Turning Velocity [deg/s]
Measurement through motion capture system
Turning Velocity [deg/s]
Measurement through motion capture system
Double Support Percentage during walking [%]
Measurement through motion capture system
Double Support Percentage during walking [%]
Measurement through motion capture system
Double Support Percentage during walking [%]
Measurement through motion capture system
Double Support Percentage during walking [%]
Measurement through motion capture system
Swing Phase Percentage during walking [%]
Measurement through motion capture system
Swing Phase Percentage during walking [%]
Measurement through motion capture system
Swing Phase Percentage during walking [%]
Measurement through motion capture system
Swing Phase Percentage during walking [%]
Measurement through motion capture system
Stance Phase Percentage during walking [%]
Measurement through motion capture system
Stance Phase Percentage during walking [%]
Measurement through motion capture system
Stance Phase Percentage during walking [%]
Measurement through motion capture system
Stance Phase Percentage during walking [%]
Measurement through motion capture system

Secondary Outcome Measures

Full Information

First Posted
March 29, 2019
Last Updated
March 9, 2020
Sponsor
Inventram
Collaborators
Koç University
search

1. Study Identification

Unique Protocol Identification Number
NCT03907007
Brief Title
Effect of Auricular Stimulation on Locomotion in Patients With Parkinson's Disease
Official Title
Effect of Auricular Stimulation on Locomotion in Patients With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inventram
Collaborators
Koç University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Neurostimulator

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sole Medication
Arm Type
No Intervention
Arm Description
Monitoring under current prescribed medication
Arm Title
Combined stimulation & medication
Arm Type
Active Comparator
Arm Description
Concurrent usage of stimulation with the prescribed medication
Arm Title
Sole Stimulation
Arm Type
Active Comparator
Arm Description
Alternating usage of stimulation to the prescribed medication
Intervention Type
Device
Intervention Name(s)
Percutaneous electrical nerve stimulation
Other Intervention Name(s)
Stimulation & Medication
Intervention Description
Stimulation and medication at the same instant
Intervention Type
Device
Intervention Name(s)
Percutaneous electrical nerve stimulation
Other Intervention Name(s)
Stimulation Only
Intervention Description
Stimulation is given without administering medication
Primary Outcome Measure Information:
Title
Stride length [m]
Description
Measurement through motion capture system
Time Frame
Time Frame: Baseline
Title
Stride length [m]
Description
Measurement through motion capture system
Time Frame
Time Frame: 20 minutes after stimulation is initiated
Title
Stride length [m]
Description
Measurement through motion capture system
Time Frame
Time Frame: 40 minutes after stimulation is initiated
Title
Stride length [m]
Description
Measurement through motion capture system
Time Frame
Time Frame: 60 minutes after stimulation is initiated
Title
Stride velocity [m/s]
Description
Measurement through motion capture system
Time Frame
Time Frame: Baseline
Title
Stride velocity [m/s]
Description
Measurement through motion capture system
Time Frame
Time Frame: 20 minutes after stimulation is initiated
Title
Stride velocity [m/s]
Description
Measurement through motion capture system
Time Frame
Time Frame: 40 minutes after stimulation is initiated
Title
Stride velocity [m/s]
Description
Measurement through motion capture system
Time Frame
Time Frame: 60 minutes after stimulation is initiated
Title
Turning Velocity [deg/s]
Description
Measurement through motion capture system
Time Frame
Time Frame: Baseline
Title
Turning Velocity [deg/s]
Description
Measurement through motion capture system
Time Frame
Time Frame: 20 minutes after stimulation is initiated
Title
Turning Velocity [deg/s]
Description
Measurement through motion capture system
Time Frame
Time Frame: 40 minutes after stimulation is initiated
Title
Turning Velocity [deg/s]
Description
Measurement through motion capture system
Time Frame
Time Frame: 60 minutes after stimulation is initiated
Title
Double Support Percentage during walking [%]
Description
Measurement through motion capture system
Time Frame
Time Frame: Baseline, 20 minutes, 40 minutes, 60 minutes
Title
Double Support Percentage during walking [%]
Description
Measurement through motion capture system
Time Frame
Time Frame: 20 minutes after stimulation is initiated
Title
Double Support Percentage during walking [%]
Description
Measurement through motion capture system
Time Frame
Time Frame: 40 minutes after stimulation is initiated
Title
Double Support Percentage during walking [%]
Description
Measurement through motion capture system
Time Frame
Time Frame: 60 minutes after stimulation is initiated
Title
Swing Phase Percentage during walking [%]
Description
Measurement through motion capture system
Time Frame
Time Frame: Baseline
Title
Swing Phase Percentage during walking [%]
Description
Measurement through motion capture system
Time Frame
Time Frame: 20 minutes after stimulation is initiated
Title
Swing Phase Percentage during walking [%]
Description
Measurement through motion capture system
Time Frame
Time Frame: 40 minutes after stimulation is initiated
Title
Swing Phase Percentage during walking [%]
Description
Measurement through motion capture system
Time Frame
Time Frame: 60 minutes after stimulation is initiated
Title
Stance Phase Percentage during walking [%]
Description
Measurement through motion capture system
Time Frame
Time Frame: Baseline, 20 minutes, 40 minutes, 60 minutes
Title
Stance Phase Percentage during walking [%]
Description
Measurement through motion capture system
Time Frame
Time Frame: 20 minutes after stimulation is initiated
Title
Stance Phase Percentage during walking [%]
Description
Measurement through motion capture system
Time Frame
Time Frame: 40 minutes after stimulation is initiated
Title
Stance Phase Percentage during walking [%]
Description
Measurement through motion capture system
Time Frame
Time Frame: 60 minutes after stimulation is initiated

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 >= 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yusuf O Cakmak, MD, PhD
Organizational Affiliation
Otago University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Koc University Hospital
City
İstanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33117256
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs