Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2026-02-21 @ 11:36 PM
Study NCT ID:
NCT05523466
Status:
UNKNOWN
Last Update Posted:
2022-08-31
First Post:
2022-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Acupuncture on Heart Rate Variability in Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-18', 'size': 445114, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-08-17T14:46', 'hasProtocol': True}, {'date': '2019-01-18', 'size': 265469, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-08-17T14:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-29', 'studyFirstSubmitDate': '2022-07-25', 'studyFirstSubmitQcDate': '2022-08-29', 'lastUpdatePostDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the Heart Rate Variability after intervention', 'timeFrame': '84 days', 'description': "the capture strap will be placed on the volunteers' chests, and the heart rate receiver (V800, Polar) will be placed on their wrists"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The Objective of this study is to evaluate the heart rate variability in individuals with multiple sclerosis during the applicability of Acupuncture, to analyze the behavior of the autonomic nervous system before, during, and after therapy and the changes of the condition.', 'detailedDescription': 'A double-blinded randomized sham-controlled crossover trial with a 1:1 allocation ratio will be conducted, 40 individuals without previous illness will be evaluated, who will constitute the control group and 40 individuals with MS will constitute the experimental group, paired by age and gender. All participants will undertake active or sham acupuncture sessions. Active-Sham group will start with 5 sessions (1 per week) of active acupuncture combined with HRV evaluation for 20 min. After a 2-week washout, this group will be reallocated to another 5 sessions (1 per week) of sham acupuncture for 20 min combined with HRV evaluation. Meanwhile, Sham-Active group will carry out the opposite protocol, participants will start an allocated 5 sessions (1 per week) of sham acupuncture combined with HRV evaluation, and after a 1-week washout period will be reallocated to 5 sessions (1 per week) of active acupuncture combined with HRV evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals diagnosed with Multiple Sclerosis\n* Aged over 18 years\n* Motor and intellectual capacity to understand the evaluations\n* Light and moderate functional classification levels (EDSS scale)\n* Who accept to participate in the study through agreement with informed consent form\n\nExclusion Criteria:\n\n* Do not understand the evaluations\n* Cardiac diseases that impede the assessment of HRV\n* Have a cardiac pacemaker.'}, 'identificationModule': {'nctId': 'NCT05523466', 'briefTitle': 'Effect of Acupuncture on Heart Rate Variability in Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Effect of Acupuncture on Heart Rate Variability in Individuals With Multiple Sclerosis', 'orgStudyIdInfo': {'id': '1239/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active-Sham group', 'description': 'will start with 5 sessions (1 per week) of active acupuncture combined with HRV evaluation for 20 min. After a 2-week washout, this group will be reallocated to another 5 sessions (1 per week) of sham acupuncture for 20 min combined with HRV evaluation.', 'interventionNames': ['Other: Acupuncture Active', 'Other: Acupuncture Sham']}, {'type': 'EXPERIMENTAL', 'label': 'Sham-Active group', 'description': 'will start an allocated 5 sessions (1 per week) of sham acupuncture combined with HRV evaluation, and after a 1-week washout period will be reallocated to 5 sessions (1 per week) of active acupuncture combined with HRV evaluation.', 'interventionNames': ['Other: Acupuncture Active', 'Other: Acupuncture Sham']}], 'interventions': [{'name': 'Acupuncture Active', 'type': 'OTHER', 'description': 'Immediately after the placement of the Polar V800, an instrument for analyzing heart rate variability, the placing of needles at the points carefully selected for this research begins. The needling will proceed for the Active acupuncture using specific Traditional Chinese Acupuncture points: E36, BP6, F3, IG4, for 20 minutes.', 'armGroupLabels': ['Active-Sham group', 'Sham-Active group']}, {'name': 'Acupuncture Sham', 'type': 'OTHER', 'description': 'Immediately after the placement of the Polar V800, an instrument for analyzing heart rate variability, the placing of needles at the points carefully selected for this research begins. The needling will proceed for the Sham acupuncture using sham points (points not recognized as Acupuncture points), with the duration of 20 minutes', 'armGroupLabels': ['Active-Sham group', 'Sham-Active group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Talita D Silva, Dr', 'role': 'CONTACT', 'email': 'ft.talitadias@gmail.com', 'phone': '+5511998590188'}], 'overallOfficials': [{'name': 'Celso Ferreira, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of São Paulo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical professor', 'investigatorFullName': 'Talita Dias da Silva', 'investigatorAffiliation': 'University of Sao Paulo'}}}}