Evaluation of a Millimeter Wave Emission Bracelet for Improving Parkinson's Disease Symptoms
NCT ID: NCT04648150
Last Updated: 2024-12-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2021-05-18
2023-05-05
Brief Summary
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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.
Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
OTHER
TRIPLE
Study Groups
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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
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
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Remedee SA
INDUSTRY
Fondation Ophtalmologique Adolphe de Rothschild
NETWORK
Responsible Party
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Locations
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Hopital Fondation Adolphe de Rothschild
Paris, , France
Centre Hospitalier de Voiron
Voiron, , France
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CHH_2020_32
Identifier Type: -
Identifier Source: org_study_id