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

Study Overview
=================
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.

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

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Device: Electro-stimulation
* Other: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Wearable stimulators will be placed on the patients and controls without stimulation for 20 minutes | Other: Placebo<br> <br> |
| Experimental: Active Stimulation<br>Instrinsic auricular muscles will be stimulated for 20 minutes | Device: Electro-stimulation<br> <br> |
| Sham Comparator: Sham<br>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<br> <br> |
| No Intervention: Passive Control<br>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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the UPDRS Motor Score (Part III) | 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) | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the gait and balance parameters (cadence) | cadence | 10 minutes after the stimulation is initiated. | 
| Change in the gait and balance parameters (Stride length) | Stride length in meters | 10 minutes after the stimulation is initiated. | 
| Change in the gait and balance parameters (Stride velocity) | Stride velocity in m/s | 10 minutes after the stimulation is initiated. | 
| Change in the gait and balance parameters | Arm Swing Rate | 10 minutes after the stimulation is initiated. | 
| Change in the gait and balance parameters | Arm Range of Motion | 10 minutes after the stimulation is initiated. | 
| Change in the gait and balance parameters | Sit to Stand Duration | 10 minutes after the stimulation is initiated. | 
| Change in the gait and balance parameters | Sit to Stand Peak Trunk Velocity | 10 minutes after the stimulation is initiated. | 
| Change in the gait and balance parameters | Sit to Stand Peak Trunk Angle | 10 minutes after the stimulation is initiated. | 
| Change in the gait and balance parameters | Leg Swing Rate | 10 minutes after the stimulation is initiated. | 
| Change in the gait and balance parameters | Leg Range of Motion | 10 minutes after the stimulation is initiated. | 
| Change in the gait and balance parameters | Turn to Sit Peak Turn Velocity | 10 minutes after the stimulation is initiated. | 
| Change in the gait and balance parameters | Turn-to-Sit Trunk Range of Motion in Sagittal Plane | 10 minutes after the stimulation is initiated. | 
| Change in the gait and balance parameters | Knee Range of Motion | 10 minutes after the stimulation is initiated. | 
| Change in the gait and balance parameters | Trunk Joint Angles | 10 minutes after the stimulation is initiated. | 
| Change in the gait and balance parameters (cadence) | cadence | 30 minutes after the stimulation is terminated. | 
| Change in the gait and balance parameters (Stride length) | Stride length in meters | 30 minutes after the stimulation is terminated. | 
| Change in the gait and balance parameters (Stride velocity) | Stride velocity in m/s | 30 minutes after the stimulation is terminated. | 
| Change in the gait and balance parameters | Arm Swing Rate | 30 minutes after the stimulation is terminated. | 
| Change in the gait and balance parameters | Arm Range of Motion | 30 minutes after the stimulation is terminated. | 
| Change in the gait and balance parameters | Sit to Stand Duration | 30 minutes after the stimulation is terminated. | 
| Change in the gait and balance parameters | Sit to Stand Peak Trunk Velocity | 30 minutes after the stimulation is terminated. | 
| Change in the gait and balance parameters | Sit to Stand Peak Trunk Angle | 30 minutes after the stimulation is terminated. | 
| Change in the gait and balance parameters | Leg Swing Rate | 30 minutes after the stimulation is terminated. | 
| Change in the gait and balance parameters | Leg Range of Motion | 30 minutes after the stimulation is terminated. | 
| Change in the gait and balance parameters | Turn-to-Sit Peak Turn Velocity | 30 minutes after the stimulation is terminated. | 
| Change in the gait and balance parameters | Turn-to-Sit Trunk Range of Motion | 30 minutes after the stimulation is terminated. | 
| Change in the gait and balance parameters | Knee Range of Motion | 30 minutes after the stimulation is terminated. | 
| Change in the gait and balance parameters | Trunk Joint Angles | 30 minutes after the stimulation is terminated. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
motor symptoms