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| Name | Class |
|---|---|
| Commissariat A L'energie Atomique | OTHER_GOV |
| Remedee SA | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Millimeter wave emitter status 1 | Active Comparator | Somatosensory stimulus during Magnetoencephalography (MEG) records |
|
| Millimeter wave emitter status 2 | Sham Comparator | Somatosensory stimulus during Magnetoencephalography (MEG) records |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Millimeter waves local exposure | Device | several blocks of somatosensory evoked potentials with or without Millimeter waves local exposure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Variation of the sympathovagal balance following the application of millimeter waves | Comparison of heart rate variability before and after application of millimeter waves | 4 hours |
| Changes in resting brain activity during or after application of millimeter waves to the wrist |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinatec Cea/Chuga | Grenoble | 38054 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31476429 | Background | 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. | |
| 18064600 | Background | Radzievsky 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. |
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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.
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Characterization of oscillatory brain activity by frequency bands (power maps) |
| 4 hours |
| 9343112 | Background | Rojavin 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. |