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N/A N=60 Randomized Triple-blind Other

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

Parkinson Disease

Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: 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 — 6; 13 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Evaluation of a millimeter wave emission bracelet for improving Parkinson's disease symptoms (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Primary completion
May 2023

Outcome Measures

OutcomeResultp-value
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
6; 13

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.

Eligibility Criteria

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 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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04648150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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