CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Evaluation of a millimeter wave emission bracelet for improving Parkinson's disease symptomsdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04648150
NCT04648150N/ACompleted

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

Fondation Ophtalmologique Adolphe de Rothschild·interventional·Posted Dec 1, 2020·Updated Dec 13, 2024

In Brief

A clinical study evaluating Evaluation of a millimeter wave emission bracelet for improving Parkinson's disease symptoms for Parkinson Disease. Completed, enrolled 60 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
CollaboratorsRemedee SA

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 1, 2020
Enrollment StartMay 18, 2021
Primary CompletionMay 5, 2023
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 5.6 years ago

Interventions

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

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