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

December 10, 2024 updated by: Fondation Ophtalmologique Adolphe de Rothschild

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Hôpital Fondation Adolphe de Rothschild
      • Voiron, France, 38506
        • Centre Hospitalier de Voiron

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VERUM
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
Evaluation of a millimeter wave emission bracelet -type medical device for improving Parkinson's disease symptoms: multicenter, double-blind randomized controlled trial
Sham Comparator: SHAM
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
Evaluation of a millimeter wave emission bracelet -type medical device for improving Parkinson's disease symptoms: multicenter, double-blind randomized controlled trial

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
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.
two months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Collaborators

Remedee SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2021

Primary Completion (Actual)

May 5, 2023

Study Completion (Actual)

May 5, 2023

Study Registration Dates

First Submitted

November 19, 2020

First Submitted That Met QC Criteria

November 27, 2020

First Posted (Actual)

December 1, 2020

Study Record Updates

Last Update Posted (Actual)

December 13, 2024

Last Update Submitted That Met QC Criteria

December 10, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHH_2020_32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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