Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 6:00 PM
Study NCT ID:
NCT04801550
Status:
COMPLETED
Last Update Posted:
2022-01-21
First Post:
2021-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Somatosensory Responses During Millimeter Waves Application
Sponsor:
University Hospital, Grenoble
Organization:
Study Overview
Official Title:
Study of Somatosensory Responses During Millimeter Waves Application (RESOM)
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESOM
Brief 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: