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NCT Number: NCT04648150

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Fondation Adolphe de Rothschild, Paris, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluation of a millimeter wave emission bracelet for improving Parkinson's disease symptoms

Device

Evaluation of a millimeter wave emission bracelet -type medical device for improving Parkinson's disease symptoms: multicenter, double-blind randomized controlled trial

Primary outcomes

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

Time frame: two months after inclusion

Decrease of 3.25 points or more in the Movement Disorder Society Unified Parkinson Disease Rating Scale III from inclusion.

The Movement Disorder Society Unified Parkinson Disease Rating Scale III (MDS-UPDRS III score evaluation) will be performed under ON Dopa conditions and blinded from the randomization arm.

The MDS-UPDRS III varies from 0 to199, a higher score meaning a worse outcome.

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Collaborators

Remedee SA

Registry information

Official study title

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

Acronym: BOMP

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Dec 1, 2020
Registry last updated: Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed