Clinical trial: Study of Somatosensory Responses During Millimeter Waves Application (NCT04801550)

Eligibility criteria:
Inclusion Criteria:

          1. Healthy male voluntary subject, aged 18 to 40 inclusive.

          2. Right-handed subject verified by the Edinburgh test.

          3. Body mass index (BMI) between 18 and 25 kg/m2 inclusive.

          4. Blood pressure and heart rate considered clinically normal by the investigators.

          5. Having benefited from a medical examination before participating in the research.

          6. Volunteer with a wrist circumference between 14.5 and 21 cm (wrist compatible with the
             size of the bracelet).

          7. 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

        Exclusion Criteria:

          1. Any history or presence of chronic disease.

          2. Volunteer presenting chronic pain and / or headache.

          3. Metal or silicon allergy.

          4. Volunteer with a piercing or an implanted metallic material on the internal face of
             the right wrist.

          5. Volunteer with a tattoo on the inside of the right wrist.

          6. People with contraindications to MRI.

          7. Taking treatment that could impact the physiological measurements recorded.

          8. Consumption of analgesics or anti-inflammatory drugs during the week before each MEG
             examination.

          9. Surgical intervention within the last 3 months.

         10. Alcohol consumption within the last 24 hours, for each visit.

         11. Achievement of a sporting effort within the last 24 hours, for each visit.

         12. Volunteer with difficulties to be cooperative during the study in the opinion of the
             investigator (i.e.: language problem, poor mental development, etc.).

         13. Volunteer in period of exclusion from another study.

         14. 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.

         15. 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.

         16. Volunteer who cannot be contacted in case of emergency.

         17. Volunteer who have already used an millimeter wave emitter before the study.
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years

Patient description (medical language): A 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? Contradiction