Ignite Creation Date:
2025-12-24 @ 12:25 PM
Ignite Modification Date:
2026-04-05 @ 12:54 AM
Study NCT ID:
NCT05108961
Status:
COMPLETED
Last Update Posted:
2023-02-14
First Post:
2021-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Impact of an Acupuncture Session in Healthy Volunteers on the Kinetics of Cerebral Activity Using the Bispectral Index (BIS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-13', 'studyFirstSubmitDate': '2021-10-15', 'studyFirstSubmitQcDate': '2021-10-26', 'lastUpdatePostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bispectral Index', 'timeFrame': '35 minutes', 'description': 'Bispectral Index (BIS) measured every second for 35 min through an EEG'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acupuncture', 'Healthy Volunteers']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteer\n* Over 18 years old and less than 65.\n* Having given his express consent\n* Affiliated to a social security scheme or beneficiary of such a scheme\n\nExclusion Criteria:\n\n* Medical history of psychiatric disorders\n* Psychotropic treatment\n* narcolepsy\n* Obstructive sleep apnea syndrome\n* Symptoms that may correspond to COVID 19\n* Nickel allergy\n* Refusal to participate in the study\n* Protected subjects : Adults under guardianship, curatorship or other legal protection deprived of their liberty by judicial or administrative decision\n* Pregnant, breastfeeding or parturient woman\n* Subject hospitalized without consent'}, 'identificationModule': {'nctId': 'NCT05108961', 'acronym': 'Bisprectral2', 'briefTitle': 'Evaluation of the Impact of an Acupuncture Session in Healthy Volunteers on the Kinetics of Cerebral Activity Using the Bispectral Index (BIS)', 'organization': {'class': 'OTHER', 'fullName': 'Elsan'}, 'officialTitle': 'Randomized Propective Study Evaluating the Impact of an Acupuncture Session in Healthy Volunteers on the Kinetics of Cerebral Activity Using the Bispectral Index (BIS)', 'orgStudyIdInfo': {'id': '2021-A01814-37'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupuncture arm', 'description': 'One session of acupuncture with precise acupuncture points', 'interventionNames': ['Procedure: Acupuncture', 'Behavioral: A digital stress scale', 'Behavioral: a relaxation questionnaire', 'Diagnostic Test: Bispectral Index']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham acupuncture arm', 'description': 'One session of sham acupunture (needles inserted 1 mm, outside the acupuncture points)', 'interventionNames': ['Behavioral: A digital stress scale', 'Behavioral: a relaxation questionnaire', 'Diagnostic Test: Bispectral Index']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control arm', 'description': 'One session where no needles are inserted, the subject lies down under the same conditions as group 1 and 2', 'interventionNames': ['Behavioral: A digital stress scale', 'Behavioral: a relaxation questionnaire', 'Diagnostic Test: Bispectral Index']}], 'interventions': [{'name': 'Acupuncture', 'type': 'PROCEDURE', 'description': 'one session with precise acupunture points', 'armGroupLabels': ['Acupuncture arm']}, {'name': 'A digital stress scale', 'type': 'BEHAVIORAL', 'description': '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)', 'armGroupLabels': ['Acupuncture arm', 'Control arm', 'Sham acupuncture arm']}, {'name': 'a relaxation questionnaire', 'type': 'BEHAVIORAL', 'description': 'The Global Relaxation Questionnaire after the session: Dovero Global Relaxation Scale', 'armGroupLabels': ['Acupuncture arm', 'Control arm', 'Sham acupuncture arm']}, {'name': 'Bispectral Index', 'type': 'DIAGNOSTIC_TEST', 'description': 'BIS is based on an EEG analysis algorithm', 'armGroupLabels': ['Acupuncture arm', 'Control arm', 'Sham acupuncture arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33600', 'city': 'Pessac', 'country': 'France', 'facility': 'Clinique Saint Martin', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elsan', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Clinical Trial Experts Network', 'class': 'OTHER'}, {'name': 'Clinique saint martin Pessac', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}