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

Parkinson Disease Clinical Trial

— BOMP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04648150
• Other study ID #: CHH_2020_32
• Status: Completed
• Phase: N/A
• Start date: May 18, 2021
• Est. completion date: May 5, 2023

Study information

• Verified date: May 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 5, 2023
• Est. primary completion date: May 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
France	Hopital Fondation Adolphe de Rothschild	Paris
France	Centre Hospitalier de Voiron	Voiron

Sponsors (2)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild	Remedee SA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The Movement Disorder Society Unified Parkinson Disease Rating Scale III (MDS-UPDRS III score evaluation see Appendix 1) will be performed under ON Dopa conditions and blinded from the randomization arm.; The MDS-UPDRS III evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Each parkinsonian sign or symptom is rated on a 5-point Likert-type scale (ranging from 0 to 4), with higher scores indicating more severe impairment. The maximum total MDS-UPDRS III score is 199, indicating the worst possible disability from Parkinson disease.	two months after inclusion