Healthy VolunteersRESOMNCT04801550
Study of Somatosensory Responses During Millimeter Waves Application
A study testing Millimeter waves local exposure in people with Healthy Volunteers, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The brain activity induced by a sensory stimulus and measured by magnetoencephalography will be compared before and after exposure to millimeter waves. We hypothesize that brain activity is modified after exposure to millimeter waves. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Millimeter waves local exposure
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jul 2021to 17 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male voluntary subject, aged 18 to 40 inclusive.
- Right-handed subject verified by the Edinburgh test.
- Body mass index (BMI) between 18 and 25 kg/m2 inclusive.
- Blood pressure and heart rate considered clinically normal by the investigators.
- Having benefited from a medical examination before participating in the research.
- Volunteer with a wrist circumference between 14.5 and 21 cm (wrist compatible with the size of the bracelet).
- Adults, having expressed their consent to research, affiliated to a social security scheme and registered in the national file of people who lend themselves to biomedical research
Who cannot join
- Any history or presence of chronic disease.
- Volunteer presenting chronic pain and / or headache.
- Metal or silicon allergy.
- Volunteer with a piercing or an implanted metallic material on the internal face of the right wrist.
- Volunteer with a tattoo on the inside of the right wrist.
- People with contraindications to MRI.
Show all 17Show fewer
- Taking treatment that could impact the physiological measurements recorded.
- Consumption of analgesics or anti-inflammatory drugs during the week before each MEG examination.
- Surgical intervention within the last 3 months.
- Alcohol consumption within the last 24 hours, for each visit.
- Achievement of a sporting effort within the last 24 hours, for each visit.
- Volunteer with difficulties to be cooperative during the study in the opinion of the investigator (i.e.: language problem, poor mental development, etc.).
- Volunteer in period of exclusion from another study.
- Volunteer deprived of liberty by a judicial or administrative decision, subject to psychiatric treatment, or major subject subject to a legal protection measure (guardianship, guardianship and safeguard of justice) referred to in articles 1121-6 to 1121-8 of the French public health code.
- Volunteer who would receive more than 4,500 euros in compensation as a result of his participation in other research involving the human person in the 12 months preceding this study.
- Volunteer who cannot be contacted in case of emergency.
- Volunteer who have already used an millimeter wave emitter before the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Somatosensory Responses During Millimeter Waves Application (RESOM)
The brain activity induced by a sensory stimulus and measured by magnetoencephalography will be compared before and after exposure to millimeter waves. We hypothesize that brain activity is modified after exposure to millimeter waves. The neuromodulatory effects of millimeter waves may lead to future development on therapeutic management in anxiety and pain.
Read the detailed description
Several studies showed clinical efficacy of millimeter waves in pain management, with no side-effects.
However, its mechanism of action is still partly unknown. Preclinical studies showed that the use of millimeter waves near highly-innervated areas stimulates subcutaneous receptors, even at low power.
To achieve safe millimeter wave stimulation, we will use a bracelet (Remedee Labs) emitting millimeter waves, that has been developped for human use. It complies with radiofrequency exposure regulation (CE-marked).
This study aims to provide a better understanding of the mechanism by which millimeter waves interact with somatosensory system in brain.
For this purpose, the analysis of brain activity will focus on somatosensory responses elicited by electrical stimulation of the right thumb.
Subjects will complete two sessions during which the brain activity will be recorded by magnetoencephalography (MEG) before, during and after the use of a bracelet emitting millimeter waves.
Magnetoencephalography is chosen for its good temporal resolution, its sensitivity in the low frequencies and its accuracy to locate neural sources when matching with an Magnetic Resonance (MR) Imagery. It will allow us to study the shape and the delay of the somatosensory response in primary somatosensory cortex (SI) and secondary somatosensory cortex (SII) cortical areas of the brain.
- Conditions
- Healthy Volunteers
- Being tested
- Millimeter waves local exposure
- Keywords
- Somatosensory stimulus, Millimeter Waves, Magnetoencephalography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Millimeter waves local exposureDevice
several blocks of somatosensory evoked potentials with or without Millimeter waves local exposure
| Study group | Role | What they receive |
|---|---|---|
| Millimeter wave emitter status 1 | Active comparator | Somatosensory stimulus during Magnetoencephalography (MEG) records Receives: Device: Millimeter waves local exposure |
| Millimeter wave emitter status 2 | Sham comparator | Somatosensory stimulus during Magnetoencephalography (MEG) records Receives: Device: Millimeter waves local exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the somatosensory responses induced by the application of millimeter waves to the wrist
Statistically significant change in the evoked somatosensory magnetic activity time course
Measured: 4 hours
Secondary outcomes (2)
Variation of the sympathovagal balance following the application of millimeter waves
Comparison of heart rate variability before and after application of millimeter waves
Measured: 4 hours
Changes in resting brain activity during or after application of millimeter waves to the wrist
Characterization of oscillatory brain activity by frequency bands (power maps)
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start22 Jul 2021
- Primary completion17 Dec 2021
- Study completion17 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is an exploratory and prospective study. Each volunteer will undergo two MEG examinations (4h-long each) without knowing the millimeter wave emitter status. Each volunteer acts as their own control. The status of exposure to millimeter waves is randomized. The study is cross-over and double-blinded.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Commissariat A L'energie Atomique, Remedee SA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801550
- Sponsor's protocol ID
- 38RC20.370
- Acronym
- RESOM
- Status last verified
- Jan 2022
- First submitted
- 5 Mar 2021
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fioravanti C, Kajal SD, Carboni M, Mazzetti C, Ziemann U, Braun C. Inhibition in the somatosensory system: An integrative neuropharmacological and neuroimaging approach. Neuroimage. 2019 Nov 15;202:116139. doi: 10.1016/j.neuroimage.2019.116139. Epub 2019 Aug 30.
PubMed 31476429Radzievsky AA, Gordiienko OV, Alekseev S, Szabo I, Cowan A, Ziskin MC. Electromagnetic millimeter wave induced hypoalgesia: frequency dependence and involvement of endogenous opioids. Bioelectromagnetics. 2008 May;29(4):284-95. doi: 10.1002/bem.20389.
PubMed 18064600Rojavin MA, Ziskin MC. Electromagnetic millimeter waves increase the duration of anaesthesia caused by ketamine and chloral hydrate in mice. Int J Radiat Biol. 1997 Oct;72(4):475-80. doi: 10.1080/095530097143248.
PubMed 9343112
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Somatosensory Responses During Millimeter Waves Application (RESOM)
- ClinicalTrials.gov ID
- NCT04801550
- Acronym / sponsor ID
- RESOM / 38RC20.370
- Conditions
- Healthy Volunteers
- Keywords
- Somatosensory stimulus, Millimeter Waves, Magnetoencephalography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Commissariat A L'energie Atomique, Remedee SA
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The brain activity induced by a sensory stimulus and measured by magnetoencephalography will be compared before and after exposure to millimeter waves. We hypothesize that brain activity is modified after exposure to millimeter waves. The neuromodulatory effects of millimeter waves may lead to future development on therapeutic management in anxiety and pain.
Detailed description
Several studies showed clinical efficacy of millimeter waves in pain management, with no side-effects.
However, its mechanism of action is still partly unknown. Preclinical studies showed that the use of millimeter waves near highly-innervated areas stimulates subcutaneous receptors, even at low power.
To achieve safe millimeter wave stimulation, we will use a bracelet (Remedee Labs) emitting millimeter waves, that has been developped for human use. It complies with radiofrequency exposure regulation (CE-marked).
This study aims to provide a better understanding of the mechanism by which millimeter waves interact with somatosensory system in brain.
For this purpose, the analysis of brain activity will focus on somatosensory responses elicited by electrical stimulation of the right thumb.
Subjects will complete two sessions during which the brain activity will be recorded by magnetoencephalography (MEG) before, during and after the use of a bracelet emitting millimeter waves.
Magnetoencephalography is chosen for its good temporal resolution, its sensitivity in the low frequencies and its accuracy to locate neural sources when matching with an Magnetic Resonance (MR) Imagery. It will allow us to study the shape and the delay of the somatosensory response in primary somatosensory cortex (SI) and secondary somatosensory cortex (SII) cortical areas of the brain.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is an exploratory and prospective study. Each volunteer will undergo two MEG examinations (4h-long each) without knowing the millimeter wave emitter status. Each volunteer acts as their own control. The status of exposure to millimeter waves is randomized. The study is cross-over and double-blinded.
| Arm | Type | Receives |
|---|---|---|
| Millimeter wave emitter status 1 | Active comparator | Device: Millimeter waves local exposureSomatosensory stimulus during Magnetoencephalography (MEG) records |
| Millimeter wave emitter status 2 | Sham comparator | Device: Millimeter waves local exposureSomatosensory stimulus during Magnetoencephalography (MEG) records |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male voluntary subject, aged 18 to 40 inclusive.
- Right-handed subject verified by the Edinburgh test.
- Body mass index (BMI) between 18 and 25 kg/m2 inclusive.
- Blood pressure and heart rate considered clinically normal by the investigators.
- Having benefited from a medical examination before participating in the research.
Key exclusion criteria (17 listed)
- Any history or presence of chronic disease.
- Volunteer presenting chronic pain and / or headache.
- Metal or silicon allergy.
- Volunteer with a piercing or an implanted metallic material on the internal face of the right wrist.
- Volunteer with a tattoo on the inside of the right wrist.
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 |
|---|---|---|
| Millimeter waves local exposureseveral blocks of somatosensory evoked potentials with or without Millimeter waves local exposure | Device | Millimeter wave emitter status 1, Millimeter wave emitter status 2 |
Primary outcome
Change in the somatosensory responses induced by the application of millimeter waves to the wrist
Time frame: 4 hours
Statistically significant change in the evoked somatosensory magnetic activity time course
2 secondary outcomes
Variation of the sympathovagal balance following the application of millimeter waves
Time frame: 4 hours
Changes in resting brain activity during or after application of millimeter waves to the wrist
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Background: PubMed 31476429Fioravanti C, Kajal SD, Carboni M, Mazzetti C, Ziemann U, Braun C. Inhibition in the somatosensory system: An integrative neuropharmacological and neuroimaging approach. Neuroimage. 2019 Nov 15;202:116139. doi: 10.1016/j.neuroimage.2019.116139. Epub 2019 Aug 30.
- Background: PubMed 18064600Radzievsky AA, Gordiienko OV, Alekseev S, Szabo I, Cowan A, Ziskin MC. Electromagnetic millimeter wave induced hypoalgesia: frequency dependence and involvement of endogenous opioids. Bioelectromagnetics. 2008 May;29(4):284-95. doi: 10.1002/bem.20389.
- Background: PubMed 9343112Rojavin MA, Ziskin MC. Electromagnetic millimeter waves increase the duration of anaesthesia caused by ketamine and chloral hydrate in mice. Int J Radiat Biol. 1997 Oct;72(4):475-80. doi: 10.1080/095530097143248.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Millimeter waves local exposure in people with Healthy Volunteers, run by University Hospital, Grenoble at 1 site 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 7 inclusion and 17 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 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in the somatosensory responses induced by the application of millimeter waves to the wrist (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04801550, which also lists 3 linked publications.
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 21 Jan 2022.