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

Elsan

Status: Completed

Conditions: Healthy Volunteers; Acupuncture

Treatments: Behavioral: a relaxation questionnaire; Procedure: Acupuncture; Diagnostic Test: Bispectral Index; Behavioral: A digital stress scale

Study type: Interventional

Funder types: Other

Identifiers

NCT05108961

2021-A01814-37

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups, including a placebo group

Acupuncture arm

Experimental group

Description:

One session of acupuncture with precise acupuncture points

Treatment:

Diagnostic Test: Bispectral Index

Behavioral: A digital stress scale

Procedure: Acupuncture

Behavioral: a relaxation questionnaire

Sham acupuncture arm

Sham Comparator group

Description:

One session of sham acupunture (needles inserted 1 mm, outside the acupuncture points)

Treatment:

Diagnostic Test: Bispectral Index

Behavioral: A digital stress scale

Behavioral: a relaxation questionnaire

Control arm

Placebo Comparator group

Description:

One session where no needles are inserted, the subject lies down under the same conditions as group 1 and 2

Treatment:

Diagnostic Test: Bispectral Index

Behavioral: A digital stress scale

Behavioral: a relaxation questionnaire