Parkinson Disease
Conditions
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.
Detailed 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
Interventions
DEVICEEvaluation 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
Sponsors
Remedee SA
Fondation Ophtalmologique Adolphe de Rothschild
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
ratio 1 :1 in each centre on an online randomization module
Intervention model 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. 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | two months after inclusion | 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. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| 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 | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | SHAM | Total | VERUM |
|---|---|---|---|
| Age, Continuous | 66.5 years | 68.0 years | 69.5 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment France | 30 participants | 60 participants | 30 participants |
| Sex: Female, Male Female | 16 Participants | 32 Participants | 16 Participants |
| Sex: Female, Male Male | 14 Participants | 28 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
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
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.
Time frame: two months after inclusion
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VERUM | 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 Participants |
| SHAM | 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 | 13 Participants |