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)
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2021
CompletedFirst Posted
Study publicly available on registry
November 5, 2021
CompletedStudy Start
First participant enrolled
April 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2023
CompletedFebruary 14, 2023
February 1, 2023
8 months
October 15, 2021
February 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Bispectral Index
Bispectral Index (BIS) measured every second for 35 min through an EEG
35 minutes
Study Arms (3)
Acupuncture arm
EXPERIMENTALOne session of acupuncture with precise acupuncture points
Sham acupuncture arm
SHAM COMPARATOROne session of sham acupunture (needles inserted 1 mm, outside the acupuncture points)
Control arm
PLACEBO COMPARATOROne session where no needles are inserted, the subject lies down under the same conditions as group 1 and 2
Interventions
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)
The Global Relaxation Questionnaire after the session: Dovero Global Relaxation Scale
BIS is based on an EEG analysis algorithm
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Elsanlead
- European Clinical Trial Experts Networkcollaborator
- Clinique saint martin Pessaccollaborator
Study Sites (1)
Clinique Saint Martin
Pessac, 33600, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2021
First Posted
November 5, 2021
Study Start
April 19, 2022
Primary Completion
December 13, 2022
Study Completion
January 13, 2023
Last Updated
February 14, 2023
Record last verified: 2023-02