Study of Somatosensory Responses During Millimeter Waves Application

NCT04801550 | Completed

• 1 other identifier: 38RC20.370
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Somatosensory stimulus; Millimeter Waves; Magnetoencephalography

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Variation of the sympathovagal balance following the application of millimeter waves

  4 hours

• Changes in resting brain activity during or after application of millimeter waves to the wrist

  4 hours

Study Arms (2)

Millimeter wave emitter status 1

ACTIVE COMPARATOR

Somatosensory stimulus during Magnetoencephalography (MEG) records

Device: Millimeter waves local exposure

Millimeter wave emitter status 2

SHAM COMPARATOR

Somatosensory stimulus during Magnetoencephalography (MEG) records

Device: Millimeter waves local exposure

Interventions

Millimeter waves local exposure DEVICE

several blocks of somatosensory evoked potentials with or without Millimeter waves local exposure

Millimeter wave emitter status 1; Millimeter wave emitter status 2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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 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.

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Commissariat A L'energie Atomique: collaborator
• Remedee SA: collaborator

Study Sites (1)

Clinatec Cea/Chuga

Grenoble, 38054, France

Location

Related Publications (3)

• 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.

  PMID: 31476429 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.

  PMID: 18064600 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.

  PMID: 9343112 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 17, 2021
• Study Start: July 22, 2021
• Primary Completion: December 17, 2021
• Study Completion: December 17, 2021
• Last Updated: January 21, 2022

Record last verified: 2022-01

Locations

FR (1)