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

Fondation Ophtalmologique Adolphe de Rothschild

Status: Completed

Conditions: Parkinson Disease

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

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT04648150

CHH_2020_32

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

VERUM

Experimental group

Description:

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

Treatment:

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

SHAM

Sham Comparator group

Description:

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.

Treatment:

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