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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05108961

Acronym

Bisprectral2

Enrollment

Registered

2021-11-05

Start date

2022-04-19

Completion date

2023-01-13

Last updated

2023-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acupuncture, Healthy Volunteers

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.

Interventions

PROCEDUREAcupuncture

one session with precise acupunture points

BEHAVIORALA 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)

BEHAVIORALa relaxation questionnaire

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

DIAGNOSTIC_TESTBispectral Index

BIS is based on an EEG analysis algorithm

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Bispectral Index	35 minutes	Bispectral Index (BIS) measured every second for 35 min through an EEG

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026