Evaluation of the Impact of an Acupuncture Session in Healthy Volunteers on the Kinetics of Cerebral Activity Using the Bispectral Index (BIS)

Study Overview
=================
Brief Summary
-----------------
To be able to have data on brain activity during an acupuncture session, this pilot study is necessary to evaluate the kinetics of the bispectral index. This research aims to evaluate the kinetics of the bispectral index in healthy volunteers during an acupuncture session, Sham acupuncture or resting in a lying position.

Official Title
-----------------
Randomized Propective Study Evaluating the Impact of an Acupuncture Session in Healthy Volunteers on the Kinetics of Cerebral Activity Using the Bispectral Index (BIS)

Conditions
-----------------
Acupuncture, Healthy Volunteers

Intervention / Treatment
-----------------
* Procedure: Acupuncture
* Behavioral: A digital stress scale
* Behavioral: a relaxation questionnaire
* Diagnostic Test: Bispectral Index


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteer Over 18 years old and less than 65. Having given his express consent Affiliated to a social security scheme or beneficiary of such a scheme Exclusion Criteria: Medical history of psychiatric disorders Psychotropic treatment narcolepsy Obstructive sleep apnea syndrome Symptoms that may correspond to COVID 19 Nickel allergy Refusal to participate in the study Protected subjects : Adults under guardianship, curatorship or other legal protection deprived of their liberty by judicial or administrative decision Pregnant, breastfeeding or parturient woman Subject hospitalized without consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture arm<br>One session of acupuncture with precise acupuncture points | Procedure: Acupuncture<br>* one session with precise acupunture points<br>Behavioral: A digital stress scale<br>* The digital stress scale before and after the session: Oral digital scale. The doctor asks the participant to quantify their anxiety on a virtual scale ranging from 0 (absent anxiety) to 10 (maximum anxiety imaginable)<br>Behavioral: a relaxation questionnaire<br>* The Global Relaxation Questionnaire after the session: Dovero Global Relaxation Scale<br>Diagnostic Test: Bispectral Index<br>* BIS is based on an EEG analysis algorithm<br>|
| Sham Comparator: Sham acupuncture arm<br>One session of sham acupunture (needles inserted 1 mm, outside the acupuncture points) | Behavioral: A digital stress scale<br>* The digital stress scale before and after the session: Oral digital scale. The doctor asks the participant to quantify their anxiety on a virtual scale ranging from 0 (absent anxiety) to 10 (maximum anxiety imaginable)<br>Behavioral: a relaxation questionnaire<br>* The Global Relaxation Questionnaire after the session: Dovero Global Relaxation Scale<br>Diagnostic Test: Bispectral Index<br>* BIS is based on an EEG analysis algorithm<br>|
| Placebo Comparator: Control arm<br>One session where no needles are inserted, the subject lies down under the same conditions as group 1 and 2 | Behavioral: A digital stress scale<br>* The digital stress scale before and after the session: Oral digital scale. The doctor asks the participant to quantify their anxiety on a virtual scale ranging from 0 (absent anxiety) to 10 (maximum anxiety imaginable)<br>Behavioral: a relaxation questionnaire<br>* The Global Relaxation Questionnaire after the session: Dovero Global Relaxation Scale<br>Diagnostic Test: Bispectral Index<br>* BIS is based on an EEG analysis algorithm<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bispectral Index | Bispectral Index (BIS) measured every second for 35 min through an EEG | 35 minutes |