Evaluation of the Impact of an Acupuncture Session in Healthy Volunteers on the Kinetics of Cerebral Activity Using the Bispectral Index (BIS) (Bisprectral2)

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Acupuncture
• Intervention / Treatment: Procedure: Acupuncture; Behavioral: A digital stress scale; Behavioral: a relaxation questionnaire; Diagnostic test: Bispectral Index

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pessac, France, 33600
    • Clinique Saint Martin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Acupuncture arm; One session of acupuncture with precise acupuncture points	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); Behavioral: 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
SHAM_COMPARATOR: Sham acupuncture arm; One session of sham acupunture (needles inserted 1 mm, outside the acupuncture 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); Behavioral: 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
PLACEBO_COMPARATOR: Control arm; 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; 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); Behavioral: 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

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

Collaborators and Investigators

• Sponsor: Elsan
• Collaborators: European Clinical Trial Experts Network; Clinique saint martin Pessac

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 19, 2022
• Primary Completion (ACTUAL): December 13, 2022
• Study Completion (ACTUAL): January 13, 2023

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: October 26, 2021
• First Posted (ACTUAL): November 5, 2021

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2021-A01814-37

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No