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

Study Overview
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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.

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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Percutaneous electrical nerve stimulation
* Device: Percutaneous electrical nerve stimulation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Sole Medication<br>Monitoring under current prescribed medication | |
| Active Comparator: Combined stimulation & medication<br>Concurrent usage of stimulation with the prescribed medication | Device: Percutaneous electrical nerve stimulation<br>* Stimulation and medication at the same instant<br>* Other names: Stimulation & Medication;|
| Active Comparator: Sole Stimulation<br>Alternating usage of stimulation to the prescribed medication | Device: Percutaneous electrical nerve stimulation<br>* Stimulation is given without administering medication<br>* Other names: Stimulation Only;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurostimulator