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

Not Applicable

Completed

• Conditions: Acupuncture; Healthy Volunteers
• Interventions: Procedure: Acupuncture; Behavioral: A digital stress scale; Behavioral: a relaxation questionnaire; Diagnostic Test: Bispectral Index

• Registration Number: NCT05108961
• Lead Sponsor: Elsan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-15
• Study First Submitted QC: 2021-10-26
• Study First Posted: 2021-11-05
• Study Start: 2022-04-19
• Primary Completion: 2022-12-13
• Study Completion: 2023-01-13
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-13
• Last Update Posted: 2023-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control arm	Bispectral Index	One session where no needles are inserted, the subject lies down under the same conditions as group 1 and 2
Sham acupuncture arm	a relaxation questionnaire	One session of sham acupunture (needles inserted 1 mm, outside the acupuncture points)
Sham acupuncture arm	Bispectral Index	One session of sham acupunture (needles inserted 1 mm, outside the acupuncture points)
Acupuncture arm	Acupuncture	One session of acupuncture with precise acupuncture points
Acupuncture arm	Bispectral Index	One session of acupuncture with precise acupuncture points
Control arm	A digital stress scale	One session where no needles are inserted, the subject lies down under the same conditions as group 1 and 2
Acupuncture arm	A digital stress scale	One session of acupuncture with precise acupuncture points
Acupuncture arm	a relaxation questionnaire	One session of acupuncture with precise acupuncture points
Sham acupuncture arm	A digital stress scale	One session of sham acupunture (needles inserted 1 mm, outside the acupuncture points)
Control arm	a relaxation questionnaire	One session where no needles are inserted, the subject lies down under the same conditions as group 1 and 2

Primary Outcome Measures

Name	Time	Method
Bispectral Index	35 minutes	Bispectral Index (BIS) measured every second for 35 min through an EEG

Trial Locations

Locations (1)

Clinique Saint Martin; 🇫🇷 Pessac, France