Randomized Propective Study Evaluating the Impact of an Acupuncture Session in Healthy Volunteers on the Kinetics of Cerebral Activity Using the Bispectral Index (BIS)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Bispectral Index
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy volunteer
- •Over 18 years old and less than
- •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
Arms & Interventions
Sham acupuncture arm
One session of sham acupunture (needles inserted 1 mm, outside the acupuncture points)
Intervention: Bispectral Index (Diagnostic Test)
Sham acupuncture arm
One session of sham acupunture (needles inserted 1 mm, outside the acupuncture points)
Intervention: A digital stress scale (Behavioral)
Sham acupuncture arm
One session of sham acupunture (needles inserted 1 mm, outside the acupuncture points)
Intervention: a relaxation questionnaire (Behavioral)
Acupuncture arm
One session of acupuncture with precise acupuncture points
Intervention: Acupuncture (Procedure)
Acupuncture arm
One session of acupuncture with precise acupuncture points
Intervention: A digital stress scale (Behavioral)
Acupuncture arm
One session of acupuncture with precise acupuncture points
Intervention: a relaxation questionnaire (Behavioral)
Acupuncture arm
One session of acupuncture with precise acupuncture points
Intervention: Bispectral Index (Diagnostic Test)
Control arm
One session where no needles are inserted, the subject lies down under the same conditions as group 1 and 2
Intervention: A digital stress scale (Behavioral)
Control arm
One session where no needles are inserted, the subject lies down under the same conditions as group 1 and 2
Intervention: a relaxation questionnaire (Behavioral)
Control arm
One session where no needles are inserted, the subject lies down under the same conditions as group 1 and 2
Intervention: Bispectral Index (Diagnostic Test)
Outcomes
Primary Outcomes
Bispectral Index
Time Frame: 35 minutes
Bispectral Index (BIS) measured every second for 35 min through an EEG
Secondary Outcomes
No secondary outcomes reported