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NCT05108961 Clinical Trial

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

Healthy Volunteers Clinical Trial

— Bisprectral2  

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05108961
Other study ID # 2021-A01814-37
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 19, 2022
Est. completion date January 13, 2023

Study information
Verified date February 2023
Source Elsan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date January 13, 2023
Est. primary completion date December 13, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Acupuncture
one session with precise acupunture points
Behavioral:
• A digital stress scale
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)
• a relaxation questionnaire
The Global Relaxation Questionnaire after the session: Dovero Global Relaxation Scale
Diagnostic Test:
• Bispectral Index
BIS is based on an EEG analysis algorithm

Locations
Country Name City State
France Clinique Saint Martin Pessac

Sponsors (3)
Lead Sponsor Collaborator
Elsan Clinique saint martin Pessac, European Clinical Trial Experts Network

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bispectral Index Bispectral Index (BIS) measured every second for 35 min through an EEG 35 minutes
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