Evaluation of a Millimeter Wave Emission Bracelet -Type Medical Device for Improving Parkinson's Disease Symptoms: Multicenter, Double-blind Randomized Controlled Trial
Phase: NA
Conditions: Parkinson Disease
Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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Title 
Evaluation of a Millimeter Wave Emission Bracelet -Type 
Medical Device for Improving Parkinson's Disease 
Symptoms: Multicenter, Double-blind Randomized 
Controlled Trial 
Acronym 
BOMP 
Sponsor 
Hôpital Fondation Adolphe de Rothschild 
 
Principal Investigator 
Dr Cécile Hubsch 
 
Research justification 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Idiopathic 
Parkinson's 
disease 
is 
a 
common 
neurodegenerative disorder, with a prevalence of 
approximately 2% among individuals over 65 years old in 
France, corresponding to 120,455 patients (ranging from 
94,861 to 151,896) [1]. 
This disease primarily affects the dopaminergic pathway 
(damage to the nigrostriatal pathway leads to cardinal 
symptoms such as rigidity, bradykinesia, and tremor), but 
it also impacts other systems: cholinergic, noradrenergic, 
and serotonergic [2]. 
The symptoms of Parkinson's disease are therefore motor, 
initially with a good response to dopaminergic treatments, 
but also non-motor, including sleep disturbances, loss of 
smell, 
cognitive, 
psychiatric, 
digestive, 
urinary, 
dysautonomic, and painful issues [3]. All these symptoms 
contribute to a significant reduction in the quality of life of 
patients, who, together with clinicians, are still constantly 
seeking solutions to improve management. 
Continuous dopaminergic stimulation is desirable to 
reduce motor fluctuations in patients, who experience 
motor fluctuations such as wearing-off, dyskinesias, and 
freezing [4]. Invasive techniques (deep brain stimulation, 
gamma knife lesioning, ultrasound) or devices that are 
heavy, invasive, and costly (duodopa pumps, apokinon 
pumps) have provided benefits for patients [5]. There is an 
ongoing need to explore clinical improvements using less 
expensive and lighter devices. 
The Remedee Endorphin Band is a device that emits 
electromagnetic waves in the millimeter waveband on the 
inner side of the wrist, an area rich in nerve endings. The 
device stimulates subcutaneous nerve endings and 
activates a physiological response that triggers the release 

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of endorphins in the brain. Endorphins are involved in 
several physiological processes, including pain control. 
Mu-opioid receptor (MOR) agonists not only relieve pain 
but also have effects related to dopaminergic mesolimbic 
pathways [6,7]. Indeed, the opioid and dopaminergic 
systems are closely linked at the cellular level [8]. 
Endorphins, 
by 
inhibiting 
the 
release 
of 
the 
neurotransmitter GABA when binding to the μ receptor, 
are also related to an increase in dopamine. 
The Remedee Endorphin Band is CE-marked for well-
being and sleep indications. It is undergoing clinical trials 
at the University Hospital of Grenoble as a medical device 
for 
the 
management 
of 
postoperative 
pain 
(NCT03889288), as well as for pain related to 
osteoarthritis (authorization requests ongoing) and 
migraines (NCT04568252). Several individuals using this 
band for well-being/sleep purposes have reported 
benefits on the motor symptoms of their Parkinson’s 
disease to Remedee Labs. This is why we aim to evaluate 
the contribution of the Remedee Band to the motor 
symptoms of Parkinson's disease. 
Primary objective and outcome 
Evaluate the effectiveness of two months of using the 
Remedee Endorphin Band medical device on the 
significant improvement of motor symptoms in patients 
with Parkinson's disease. 
Primary outcome measure: 
Comparison between the two treatment arms (VERUM band 
and SHAM band) of the percentage of patients showing an 
improvement of at least -3.25 points in the Movement 
Disorder Society – Unified Parkinson's Disease Rating Scale 
part III (MDS-UPDRS III) score, 2 months after 
randomization [9]. 
The evaluation of the MDS-UPDRS III score (Annex 1) will 
be conducted under ON Dopa conditions and in a blinded 
manner regarding the randomization arm. 
 
Secondary objectives and 
outcomes 
Evaluate the effectiveness of two months of using the 
Remedee Endorphin Band medical device on: 
1. Motor symptoms in patients 
2. Non-motor experiences in daily life 
3. Motor experiences in daily life 
4. Motor complications 
5. Quality of life 
6. Pain 
7. Gait 
8. Evolution of the average number of steps per week 
(only for patients who agreed to wear a second 
specific bracelet) 
9. Evolution of sleep (only for patients who agreed to 
wear a second specific bracelet) 

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10. Evolution of heart rate (only for patients who agreed 
to wear a second specific bracelet) 
11. Medication treatment 
12. Treatment effectiveness as perceived by the primary 
caregiver 
13. Treatment effectiveness as perceived by the patient 
After two months of use, the medical devices will be 
collected, and new devices (all active) will be provided to 
patients in both arms. 
The elements assessed for the primary and secondary 
objectives 1 to 10 will be described at M4 and M6 to 
document the evolution of the effect of the millimeter-wave 
stimulation medical device. 
The following secondary objectives will be purely 
descriptive: 
14) Describe the effectiveness perceived by the patient after 
discontinuing the use of the device: bi-weekly follow-up 
phone calls for 2 months after use. 
15) Evaluate the tolerance of the medical device. 
16) Evaluate the acceptability and usability of the medical 
device. 
17) Description of the device usage compliance. 
Secondary Outcome Measures: 
1. Average change in MDS-UPDRS III score under ON 
Dopa conditions 
2. Average change in MDS-UPDRS I score (Annex 2) 
under ON Dopa conditions 
3. Average change in MDS-UPDRS II score (Annex 3) 
under ON Dopa conditions 
4. Average change in MDS-UPDRS IV score (Annex 4) 
under ON Dopa conditions 
5. Average change in Parkinson Disease Questionnaire-
39 (PDQ-39) score (Annex 5) under ON Dopa 
conditions 
6. Average change in King’s PD Pain Scale (KPPS) 
score (Annex 6) under ON Dopa conditions 
7. Change in time (in seconds) required for the Stand-
Walk-Sit (SWS) test (Annex 7) under ON Dopa 
conditions. This change will be expressed as a 
percentage change in time, defined as the difference 
between the time required at baseline and 2 months 
after randomization, divided by the baseline time. 
8. Slope of the evolution in the average number of steps 
per week measured using an activity tracker (Fitbit 4) 
between -2 weeks and +8 weeks, for patients who 
agreed to wear this second bracelet. 
9. Evolution of the average number of hours of weekly 
sleep and average weekly hours of deep, paradoxical, 
light sleep, and nighttime wakefulness, measured 

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using an activity tracker (Fitbit 4) between -2 weeks 
and +8 weeks, for patients who agreed to wear this 
second bracelet. 
10. Evolution of the average weekly heart rate measured 
using an activity tracker (Fitbit 4) between -2 weeks 
and +8 weeks, for patients who agreed to wear this 
second bracelet. 
11. Percentage of patients with no change (in drug type or 
dosage) or a decrease in medication dosage. 
12. Score on the Clinical Global Impression of Change 
(CGI) questionnaire (Annex 8) at M2, taking J0 as the 
reference point, reported in person or by phone by the 
person identified by the patient as the primary 
caregiver. 
13. Score on the Clinical Global Impression of Change 
(CGI) questionnaire (Annex 8) at M2, taking J0 as the 
reference point. 
14. CGI score at M6, taking M2 as the reference, then 
every 2 weeks for two months via phone interviews. 
For phone assessments, the patient will be asked to 
use the situation from two weeks prior (during the 
previous CGI score evaluation) as the reference. 
15. Description of adverse events reported during the 
study: number, intensity, severity, duration in each of 
the two arms. 
16. Acceptability and usability questionnaire completed 
by the patient at M6 (Annex 10). 
17. Compliance assessed using the medical device log 
file (number of sessions/day, duration of sessions, 
start and end times, pause times). 
 
Study design 
Multicenter, controlled, randomized, parallel two-
arm, double-blind efficacy trial. 
Randomization will be performed with a 1:1 ratio and will 
be stratified by center. 
Population 
Patients will be recruited via neurology consultations for 
the management and monitoring of their Parkinson's 
disease. 
Selection criteria 
Inclusion Criteria 
• 
Patient aged over 18 years 
• 
Follow-up for Parkinson’s disease with progression 
for more than 5 years 
• 
Stable treatment for at least 3 months 
• 
Maintained sufficient autonomy to participate in the 
study 
• 
Non-faller: Hoehn and Yahr score in ON DOPA <4 
(Annex 9) 
• 
Informed and has signed consent to participate in the 
study 
• 
Affiliated or beneficiary of a social security scheme 

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• 
Negative urinary pregnancy test for women who are 
not postmenopausal 
Exclusion Criteria 
• 
Genetic forms of the disease 
• 
EVA > 7 in the previous week 
• 
Moderate to severe cognitive disorders 
• 
Pathology or condition (other than Parkinson’s 
disease) that could cause motor disturbances 
• 
Allergy to metals and/or silicone 
• 
Dermatological pathology on the wrists, such as 
weeping dermatosis, excessive sweating, or an 
unhealed lesion 
• 
Metal object on one of the wrists (implanted metal, 
piercing) 
• 
Presence of a tattoo on one of the wrists 
• 
Wrist circumference <14.5 cm or >21 cm, i.e., wrist 
size incompatible with the device model 
• 
Inability of the patient to apply and/or wear the 
medical device 
• 
Patient under legal protection 
• 
Pregnant or breastfeeding woman 
Secondary Exclusion Criteria: None specified in the 
protocol 
 
Trial procedures 
Experimental Therapeutic Intervention 
Medical device Remedee Endorphin Band with millimeter 
wave emission activated for a duration of 6 months, to be 
used according to the following schedule: one 30-minute 
session in the morning and one session in the evening. 
Additional sessions may be added if desired by the patient, 
up to a maximum of 4 sessions per day. 
Control Therapeutic Intervention 
Medical device Remedee Endorphin Band without millimeter 
wave emission for two months, followed by the Remedee 
Endorphin Band with millimeter wave emission activated for 
a duration of 4 months, to be used according to the following 
schedule: one 30-minute session in the morning and one 
session in the evening. Additional sessions may be added if 
desired by the patient, up to a maximum of 4 sessions per 
day. 
Conduct of the trial 
Patients seen during consultations/Day Hospital and meeting 
the inclusion and non-inclusion criteria will be offered the 
opportunity to participate in the study. If they agree, a visit 
will be scheduled (within 2 to 4 weeks) to perform the 
various tests and provide the medical device to the patient 
(VERUM or SHAM according to the randomization group). 

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Patients will be randomized into two parallel groups (1:1 
ratio) via an online randomization module. The doctor 
enrolling the patient in the study will not be aware of the 
randomization group. 
• 
Experimental Group (VERUM): Provision of an 
active medical device for a period of 2 months. Then, 
provision of a second active medical device for a 
duration of 4 months. 
• 
Control Group (SHAM): Provision of an inactive 
medical device for a duration of 2 months, followed 
by the provision of an active medical device from 
Month 2 to Month 6 after enrollment. 
Inclusion Visit (J0-2 to -4 weeks) 
• 
Verification of inclusion and non-inclusion criteria 
• 
Information and obtaining written informed consent 
from the patient 
• 
Information to the patient regarding the Fitbit 4 and 
the option to use it 
• 
Trial fitting of the Remedee Endorphin Band device 
Visit 1 (J0) 
• 
Confirmation of patient’s willingness to participate 
• 
Randomization 
• 
Provision of the medical device and instructions on its 
use 
• 
Administration of the various assessment tests (if 
necessary, after administration of Modopar 
dispersible): 
o MDS-UPDRS (I, II, III, and IV) 
o PDQ39 
o KPPS 
o SWS 
Phone Call at J7 and M1: Verification that the patient does 
not encounter any difficulties in using the device (call by the 
TEC) 
Visit 2 (M2) 
• 
Administration of the various assessment tests (if 
necessary, after administration of Modopar 
dispersible): 
o MDS-UPDRS (I, II, III, and IV) 
o PDQ39 
o KPPS 
o SWS 
• 
CGS score from the caregiver (in-person or by phone) 
• 
CGS score from the patient 

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• 
Retrieval of usage data from the medical device (log 
file) 
• 
Retrieval of the first medical device (active or 
inactive) and provision of an active medical device to 
all patients. 
Visit 3 (M4) 
• 
Administration of the various assessment tests (if 
necessary, after administration of Modopar 
dispersible): 
o MDS-UPDRS (I, II, III, and IV) 
o PDQ39 
o KPPS 
o SWS 
• 
Retrieval of usage data from the medical device (log 
file) 
Visit 4 (M6) 
• 
Administration of the various assessment tests (if 
necessary, after administration of Modopar 
dispersible): 
o MDS-UPDRS (I, II, III, and IV) 
o PDQ39 
o KPPS 
o SWS 
• 
Administration of the acceptability and usability 
questionnaire for the medical device 
• 
CGS score from the patient 
• 
Retrieval of usage data from the medical device (log 
file) 
• 
Retrieval of the millimeter-wave emitting bracelet 
• 
Retrieval of the Fitbit4 for patients who accepted its 
use 
Phone Calls at M6+2 weeks, M6+4 weeks, M6+6 weeks, 
and M6+8 weeks: CGS score from the patient, and at M6+8 
weeks, the patient will also be asked if they would have liked 
to continue using the medical device bracelet. 
Sample size 
60 (30 per arm) 
Statistical analysis 
The primary endpoint will be analysed using logistic 
regression with a centre effect. 
Planning 
Enrollement : 24 months 
Study participation for each patient : 8 months 
Total study length : 32 months