AcupunctureBisprectral2NCT05108961
Evaluation of the Impact of an Acupuncture Session in Healthy Volunteers on the Kinetics of Cerebral Activity Using the Bispectral Index (BIS)
A study testing Acupuncture, A digital stress scale and a relaxation questionnaire in people with Acupuncture and Healthy Volunteers, run by Elsan at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acupuncture, Healthy Volunteers
- What is being tested?
- Acupuncture, A digital stress scale and a relaxation questionnaire
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 19 Apr 2022to 13 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Medical history of psychiatric disorders
- Psychotropic treatment
- narcolepsy
- Obstructive sleep apnea syndrome
- Symptoms that may correspond to COVID 19
- Nickel allergy
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Propective Study Evaluating the Impact of an Acupuncture Session in Healthy Volunteers on the Kinetics of Cerebral Activity Using the Bispectral Index (BIS)
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.
- Conditions
- Acupuncture, Healthy Volunteers
- Being tested
- Acupuncture, A digital stress scale, a relaxation questionnaire, Bispectral Index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
one session with precise acupunture points
A digital stress scaleBehavioural
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)
a relaxation questionnaireBehavioural
The Global Relaxation Questionnaire after the session: Dovero Global Relaxation Scale
Bispectral IndexDiagnostic test
BIS is based on an EEG analysis algorithm
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture arm | Experimental | One session of acupuncture with precise acupuncture points Receives: Procedure: Acupuncture; Behavioral: A digital stress scale; Behavioral: a relaxation questionnaire; Diagnostic Test: Bispectral Index |
| Sham acupuncture arm | Sham comparator | One session of sham acupunture (needles inserted 1 mm, outside the acupuncture points) Receives: Behavioral: A digital stress scale; Behavioral: a relaxation questionnaire; Diagnostic Test: Bispectral Index |
| Control arm | Placebo comparator | One session where no needles are inserted, the subject lies down under the same conditions as group 1 and 2 Receives: Behavioral: A digital stress scale; Behavioral: a relaxation questionnaire; Diagnostic Test: Bispectral Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bispectral Index
Bispectral Index (BIS) measured every second for 35 min through an EEG
Measured: 35 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start19 Apr 2022
- Primary completion13 Dec 2022
- Study completion13 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcupunctureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network, Clinique saint martin Pessac
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108961
- Sponsor's protocol ID
- 2021-A01814-37
- Acronym
- Bisprectral2
- Status last verified
- Feb 2023
- First submitted
- 15 Oct 2021
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Propective Study Evaluating the Impact of an Acupuncture Session in Healthy Volunteers on the Kinetics of Cerebral Activity Using the Bispectral Index (BIS)
- ClinicalTrials.gov ID
- NCT05108961
- Acronym / sponsor ID
- Bisprectral2 / 2021-A01814-37
- Conditions
- Acupuncture, Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ElsanUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network, Clinique saint martin Pessac
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture arm | Experimental | Procedure: Acupuncture, Behavioral: A digital stress scale, Behavioral: a relaxation questionnaire, Diagnostic Test: Bispectral IndexOne session of acupuncture with precise acupuncture points |
| Sham acupuncture arm | Sham comparator | Behavioral: A digital stress scale, Behavioral: a relaxation questionnaire, Diagnostic Test: Bispectral IndexOne session of sham acupunture (needles inserted 1 mm, outside the acupuncture points) |
| Control arm | Placebo comparator | Behavioral: A digital stress scale, Behavioral: a relaxation questionnaire, Diagnostic Test: Bispectral IndexOne session where no needles are inserted, the subject lies down under the same conditions as group 1 and 2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Medical history of psychiatric disorders
- Psychotropic treatment
- narcolepsy
- Obstructive sleep apnea syndrome
- Symptoms that may correspond to COVID 19
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupunctureone session with precise acupunture points | Procedure or surgery | Acupuncture arm |
| A digital stress scaleThe 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) | Behavioural | Acupuncture arm, Control arm, Sham acupuncture arm |
| a relaxation questionnaireThe Global Relaxation Questionnaire after the session: Dovero Global Relaxation Scale | Behavioural | Acupuncture arm, Control arm, Sham acupuncture arm |
| Bispectral IndexBIS is based on an EEG analysis algorithm | Diagnostic test | Acupuncture arm, Control arm, Sham acupuncture arm |
Primary outcome
Bispectral Index
Time frame: 35 minutes
Bispectral Index (BIS) measured every second for 35 min through an EEG
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture, A digital stress scale and a relaxation questionnaire in people with Acupuncture and Healthy Volunteers, run by Elsan at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bispectral Index (time frame: 35 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.