Parkinson DiseaseBOMPNCT04648150
Evaluation of a Millimeter Wave Emission Bracelet for Improving Parkinson's Disease Symptoms
A study testing Evaluation of a millimeter wave emission bracelet for improving Parkinson's disease symptoms in people with Parkinson Disease, run by Fondation Ophtalmologique Adolphe de Rothschild at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Evaluation of a millimeter wave emission bracelet for improving Parkinson's disease symptoms
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 18 May 2021to 5 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
2 sites in 1 country.
France2 sites
Hopital Fondation Adolphe de Rothschild
Paris, 75019
Centre Hospitalier de Voiron
Voiron, 38506
About this study
Official title: Evaluation of a Millimeter Wave Emission Bracelet -Type Medical Device for Improving Parkinson's Disease Symptoms: Multicenter, Double-blind Randomized Controlled Trial
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.
Read more
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.
Read the 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
- Conditions
- Parkinson Disease
- Being tested
- Evaluation of a millimeter wave emission bracelet for improving Parkinson's disease symptoms
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of a millimeter wave emission bracelet for improving Parkinson's disease symptomsDevice
Evaluation of a millimeter wave emission bracelet -type medical device for improving Parkinson's disease symptoms: multicenter, double-blind randomized controlled trial
| Study group | Role | What they receive |
|---|---|---|
| VERUM | Experimental | 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 Receives: Device: Evaluation of a millimeter wave emission bracelet for improving Parkinson's disease symptoms |
| SHAM | Sham comparator | 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. Receives: Device: Evaluation of a millimeter wave emission bracelet for improving Parkinson's disease symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start18 May 2021
- Primary completion5 May 2023
- Study completion5 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Collaborators
- Remedee SA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648150
- Sponsor's protocol ID
- CHH_2020_32
- Acronym
- BOMP
- Status last verified
- Dec 2024
- First submitted
- 19 Nov 2020
- Last updated
- 13 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Millimeter Wave Emission Bracelet -Type Medical Device for Improving Parkinson's Disease Symptoms: Multicenter, Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04648150
- Acronym / sponsor ID
- BOMP / CHH_2020_32
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Collaborators
- Remedee SA
- Study start
- 18 May 2021 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 1 Dec 2020 (actual)
- Results
- Posted 13 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| VERUM | Experimental | Device: Evaluation of a millimeter wave emission bracelet for improving Parkinson's disease symptomsAn active wave emission bracelet for a period of 2 months. Then delivery of a second active medical device for a period of 4 months |
| SHAM | Sham comparator | Device: Evaluation of a millimeter wave emission bracelet for improving Parkinson's disease symptomsAn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of a millimeter wave emission bracelet for improving Parkinson's disease symptomsEvaluation of a millimeter wave emission bracelet -type medical device for improving Parkinson's disease symptoms: multicenter, double-blind randomized controlled trial | Device | SHAM, VERUM |
Primary outcome
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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of a millimeter wave emission bracelet for improving Parkinson's disease symptoms in people with Parkinson Disease, run by Fondation Ophtalmologique Adolphe de Rothschild at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: two months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.