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

Elsan1 site in 1 country30 target enrollmentApril 19, 2022

ConditionsAcupuncture Healthy Volunteers

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acupuncture
Sponsor: Elsan
Enrollment: 30
Locations: 1
Primary Endpoint: Bispectral Index
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

April 19, 2022

End Date

January 13, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Elsan

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy volunteer
•Over 18 years old and less than
•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