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

NCT04648150 | Completed Results

• 1 other identifier: CHH_2020_32
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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

  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

Study Arms (2)

VERUM

EXPERIMENTAL

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

SHAM

SHAM COMPARATOR

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

Interventions

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

SHAM; VERUM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead
• Remedee SA: collaborator

Study Sites (2)

Hopital Fondation Adolphe de Rothschild

Paris, 75019, France

Location

Centre Hospitalier de Voiron

Voiron, 38506, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr Amélie YAVCHITZ
• Organization: Hopital fondation Rothschild

ayavchitz@for.paris

+33148036454

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: ratio 1 :1 in each centre on an online randomization module
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: December 1, 2020
• Study Start: May 18, 2021
• Primary Completion: May 5, 2023
• Study Completion: May 5, 2023
• Last Updated: December 13, 2024
• Results First Posted: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)