Evaluation of a Millimeter Wave Emission Bracelet for Improving Parkinson's Disease Symptoms

Study Overview
=================
Brief Summary
-----------------
Idiopathic Parkinson's disease is a common neurodegenerative disease, with a prevalence of around 2% in people over 65 years of age in France. This pathology affects the dopaminergic pathway but also other systems: cholinergic, noradrenergic and serotoninergic. The symptoms of Parkinson's disease are motor but also non-motor with sleep, smell, cognitive, psychiatric, digestive, urinary, dysautonomic, painful disorders. The discomfort can be such that invasive and expensive solutions have been developed. Invasive or expensive techniques (deep brain stimulation, lesional microsurgery by gamma knife or ultrasound, duodopa or apokinon pumps) brought significant benefits to patients. Opportunities for clinical improvement using less expensive and lighter devices should be sought. The Remedee endorphin band device is a device that emits millimeter-band electromagnetic waves on the wrist. The device stimulates subcutaneous nerve endings and activates a physiological response leading to the release of endorphins in the brain. Endorphins are involved in several physiological processes, including pain control. Mu-opioid receptor (MOR) agonists do not only relieve pain, but have effects related to mesolimbic dopaminergic pathways. Indeed, the opioid and dopaminergic systems are closely linked at the cellular level. Endorphins, through inhibition of the release of the neurotransmitter GABA upon binding to the μ receptor, are also linked to an increase in dopamine.

Detailed Description
-----------------
Intervention 1 Name : VERUM Description : Experimental arm (VERUM): delivery of an active medical device for a period of 2 months. Then delivery of a second active medical device for a period of 4 months. Intervention 2 Name : SHAM Description: Control arm (SHAM): delivery of an inactive medical device for a period of 2 months of use then delivery of an active medical device from M2 to M6 after inclusion

Official Title
-----------------
Evaluation of a Millimeter Wave Emission Bracelet -Type Medical Device for Improving Parkinson's Disease Symptoms: Multicenter, Double-blind Randomized Controlled Trial

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Device: Evaluation of a millimeter wave emission bracelet for improving Parkinson's disease symptoms


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18 years old Follow-up for Parkinson's disease for more than 5 years Treatment stable for at least 3 months Having retained sufficient autonomy to allow participation in the study Hoehn and Yahr score in ON DOPA <4 Exclusion Criteria: Genetic forms of the disease EVA> 7 over the previous week Moderate to severe cognitive impairment Pathology or condition (other than Parkinson's disease) that can generate motor disorders Allergy to metals and / or silicone Dermatological pathology on the wrists Metal object at one of the wrists (implanted metal material, piercing) Presence of a tattoo on one of the wrists Wrist circumference <14.5 cm or> 21 cm i.e. wrist incompatible with the MD template Inability of the patient to put on and / or wear the template of the medical device Pregnant or breastfeeding woman

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Experimental arm (VERUM): delivery of an active medical device for a period of 2 months. Then delivery of a second active medical device for a period of 4 months. Control arm (SHAM): delivery of an inactive medical device for a period of 2 months of use then delivery of an active medical device from M2 to M6 after inclusion.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VERUM<br>An active wave emission bracelet for a period of 2 months. Then delivery of a second active medical device for a period of 4 months | Device: Evaluation of a millimeter wave emission bracelet for improving Parkinson's disease symptoms<br>* Evaluation of a millimeter wave emission bracelet -type medical device for improving Parkinson's disease symptoms: multicenter, double-blind randomized controlled trial<br>|
| Sham Comparator: SHAM<br>An inactive wave emission bracelet for a period of 2 months of use then delivery of an active medical device from M2 to M6 after inclusion. | Device: Evaluation of a millimeter wave emission bracelet for improving Parkinson's disease symptoms<br>* Evaluation of a millimeter wave emission bracelet -type medical device for improving Parkinson's disease symptoms: multicenter, double-blind randomized controlled trial<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the effectiveness of two months of use of the Remedee Endorphin Band medical device in improving motor disorders in patients with Parkinson's disease | The Movement Disorder Society Unified Parkinson Disease Rating Scale III (MDS-UPDRS III score evaluation see Appendix 1) will be performed under ON Dopa conditions and blinded from the randomization arm. The MDS-UPDRS III evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Each parkinsonian sign or symptom is rated on a 5-point Likert-type scale (ranging from 0 to 4), with higher scores indicating more severe impairment. The maximum total MDS-UPDRS III score is 199, indicating the worst possible disability from Parkinson disease. | two months after inclusion |