NCT04801550

Study of Somatosensory Responses During Millimeter Waves Application

Study of Somatosensory Responses During Millimeter Waves Application (RESOM)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DEVICE	Millimeter waves local exposure	several blocks of somatosensory evoked potentials with or without Millimeter waves local exposure

Timeline

• Start date: 2021-07-22
• Primary completion: 2021-12-17
• Completion: 2021-12-17
• First posted: 2021-03-17
• Last updated: 2022-01-21

Locations

1 site across 1 country: France