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Completed

NCT Number: NCT05108961

Evaluation of 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.

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Key information

Conditions

Acupuncture Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Saint Martin

Pessac, 33600, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Procedure

one session with precise acupunture points

A digital stress scale

Behavioral

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

Behavioral

The Global Relaxation Questionnaire after the session: Dovero Global Relaxation Scale

Bispectral Index

Diagnostic Test

BIS is based on an EEG analysis algorithm

Primary outcomes

  1. Bispectral Index

    Time frame: 35 minutes

    Bispectral Index (BIS) measured every second for 35 min through an EEG

Sponsors and collaborators

Lead sponsor

Elsan

Other

Collaborators

  • Clinique saint martin Pessac
  • European Clinical Trial Experts Network

Registry information

Official study 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)

Acronym: Bisprectral2

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Nov 5, 2021
Registry last updated
Feb 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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