Study of Somatosensory Responses During Millimeter Waves Application
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Healthy Volunteers
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention 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 (Participant, Investigator)Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 18 years and 40 years
- Gender
- Only males
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 pow...
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.
Tracking Information
- NCT #
- NCT04801550
- Collaborators
- Commissariat A L'energie Atomique
- Remedee Labs SAS
- Investigators
- Not Provided
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