Clinical trial NCT04648150: Evaluation of a Millimeter Wave Emission Bracelet for Improving Parkinson's Disease Symptoms
Official title: Evaluation of a Millimeter Wave Emission Bracelet -Type Medical Device for Improving Parkinson's Disease Symptoms: Multicenter, Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
Collaborators: name: Remedee SA
First posted: 2020-12-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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

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

Primary outcomes:
measure: 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
timeFrame: two months after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Fondation Adolphe de Rothschild
city: Voiron
country: France
facility: Centre Hospitalier de Voiron
Study officials:
References: