Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-28 @ 4:58 AM
Study NCT ID:
NCT03386903
Status:
UNKNOWN
Last Update Posted:
2017-12-29
First Post:
2017-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture Regulates Default Mode Network of Chronic Insomnia Disorder Patients : A fMRI Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-02-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2019-06-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-21', 'studyFirstSubmitDate': '2017-08-09', 'studyFirstSubmitQcDate': '2017-12-21', 'lastUpdatePostDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep quality obtained by questionnaire:Pittsburgh Sleep Quality Index', 'timeFrame': 'baseline,12 weeks', 'description': 'Change in Pittsburgh sleep quality index scores at the baseline and the end of 12 weeks stimulation with acupuncture.Minimum Score = 0 (good sleep); Maximum Score = 30 (disrupted sleep)'}], 'secondaryOutcomes': [{'measure': 'Brain gray matter', 'timeFrame': 'baseline,12 weeks', 'description': 'The changes of gray matter volume in default network before and after treatment'}, {'measure': 'Total sleep time obtained by questionnaire:Pittsburgh Sleep Quality Index', 'timeFrame': 'baseline,12 weeks'}, {'measure': 'Sleep efficiency obtained by questionnaire:Pittsburgh Sleep Quality Index', 'timeFrame': 'baseline,12 weeks'}, {'measure': 'Sleep latency obtained by questionnaire:Pittsburgh Sleep Quality Index', 'timeFrame': 'baseline,12 weeks'}, {'measure': 'Wake after sleep onset obtained by questionnaire:Pittsburgh Sleep Quality Index', 'timeFrame': 'baseline,12 weeks'}, {'measure': 'Sleep problem obtained by questionnaire:Insomnia Severity Index', 'timeFrame': 'baseline,12 weeks'}, {'measure': 'Emotional state of anxiety obtained by questionnaire:Self-Rating Anxiety Scale', 'timeFrame': 'baseline,12 weeks'}, {'measure': 'Emotional state of depression obtained by questionnaire:Self-Rating Depression Scale', 'timeFrame': 'baseline,12 weeks'}, {'measure': 'Daytime function obtained by questionnaire:Epworth Sleepiness Score', 'timeFrame': 'baseline,12 weeks'}, {'measure': 'Daytime function obtained by questionnaire:Flinders Fatigue Scale', 'timeFrame': 'baseline,12 weeks'}, {'measure': 'resting-state functional magnetic resonance imaging', 'timeFrame': 'baseline,12 weeks', 'description': 'Resting state intrinsic connectivity within the default network by MRI'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Insomnia']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate the underlying central nervous mechanisms of acupuncture treatment in chronic insomnia patients, from observation changes of gray matter and functional connectivity in the default mode network and the salience network by functional magnetic resonance imaging, and combine with clinical efficacy assessment to analyze the association between the results of imaging and behavioristic.', 'detailedDescription': 'Chronic insomnia which can cause daytime function impairments like abnormal emotion and hypomnesis is important risk factors for developing cardiovascular disease, neurological disorders or mental disorders. Acupuncture is a widely recognized therapy to treat chronic insomnia in clinical practice. Previous researches presented that sleep-wake dysfunction of patients with chronic insomnia have strong correlation with abnormal of the default mode network and salience network. The project present acupuncture may improve sleep quality by adjusting the abnormal default mode network and the salience network in patients with chronic insomnia.\n\nThe investigators are assigned the ninety eligible participants in three groups: thirty chronic insomnia patients by true acupuncture treatment (Zhoushi coordinated points), thirty chronic insomnia patients by sham acupuncture stimulation (non-acupoint points) and thirty healthy subjects, Treatment will be given 3 times per week for 3 months. Additionally, two methods include functional magnetic resonance imaging (fMRI) and clinical scales evaluation as the outcome measures to evaluate the effectiveness and security of acupuncture. Outcomes will be evaluated at baseline and 3 month post-treatment.\n\nThe aim of this project is to investigate effect of acupuncture treatment on gray matter and functional connectivity of the default network and the salience network in chronic insomnia patients, and to analyze the association between sleep quality, emotion, day function with imaging results. The central nervous mechanisms underlying acupuncture treatment are discussed by this finding which may provide scientific basis for acupuncture treatment in chronic insomnia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Insomnia group: Patients must meet DSM V criteria for chronic insomnia. PSQI\\>7 、ISI\\>7、 SAS\\<50、 SDS\\<50.\n* control group: no self-reported sleep problems in the last 1 months. PSQI≤5 、SAS\\<50、 SDS\\<50，MMSE≥27.\n* 30-60 years old.\n* Male or female.\n* Dextromanuality.\n* Having given written informed consent to participate in the research project.\n\nExclusion Criteria:\n\n* History of cardiovascular and respiratory diseases.\n* Other diagnoses of the nerve or mental disorders.\n* Other sleep disorders.\n* The long history of smoking, drinking and abusing drugs, or taking psychotropic drugs in last month, and treatment in other clinical trials at the same time.\n* The body carrying pacemakers, defibrillators, implantable vascular clamp, implantable electric or magnetic device, mechanical heart valve, artificial cochlear, el., fMRI taboo and the claustrophobic.\n* MRI scans have been used to identify patients with a definite organic lesion or severe head anatomical asymmetry\n* Pregnancy, lactation and peri menopausal women.\n* An allergy history of syncope, alcohol, and metal needle.\n* The body Mass Index\\>32 or \\<19.8.'}, 'identificationModule': {'nctId': 'NCT03386903', 'briefTitle': 'Acupuncture Regulates Default Mode Network of Chronic Insomnia Disorder Patients : A fMRI Study', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Hospital of Traditional Chinese Medicine'}, 'officialTitle': 'Acupuncture Regulates Emotion-cognitive Network of Chronic Insomnia Patients : A DTI-fMRI Study', 'orgStudyIdInfo': {'id': '2016BL-033-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ture acupuncture group', 'description': 'After recruiting, patients are assigned to the ture acupuncture group by randomization,and then receive ture acupuncture treatment. patients are scanned by MRI at the baseline and 3 month post-treatment respectively.', 'interventionNames': ['Device: Ture acupuncture']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sham acupuncture group', 'description': 'After recruiting, patients are assigned to the sham acupuncture group by randomization,and then receive sham acupuncture stimulation. patients are scanned by MRI at the baseline and 3 month post-treatment respectively.', 'interventionNames': ['Device: Sham acupuncture']}, {'type': 'NO_INTERVENTION', 'label': 'Healthy group', 'description': 'Healthy subjects without intervention except scanned brain image by MRI at the baseline.'}], 'interventions': [{'name': 'Ture acupuncture', 'type': 'DEVICE', 'otherNames': ['Experimental'], 'description': 'Patients receive true acupuncture treatment by Zhoushi coordinated points at the "Bai-hui" (DU20), "Shen-ting" (DU24), bilateral "Ben-shen" (BG13), "Shen-men" (HT7), "San-yin-jiao" (SP6) with "Deqi" sensation. The needles are retained for 20 minutes in every course, three times per week and last for 3 months.', 'armGroupLabels': ['Ture acupuncture group']}, {'name': 'Sham acupuncture', 'type': 'DEVICE', 'otherNames': ['Placebo Comparator'], 'description': 'Patients receive sham acupuncture stimulation by non-acupoint points (superficial insertion, 0.2 cun, No needle sensation (de qi) is elicited) at the bilateral mid-point between Shuaigu(GB8) and Touwei(ST8), Touwei(ST8) and Yangbai(GB14), front tibia, the junction of biceps and triceps.', 'armGroupLabels': ['Sham acupuncture group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Hostipal of Traditional Chinese Medicine affiliated to Capital medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Liu c zhi, M.D', 'role': 'CONTACT', 'email': 'lcz623780@126.com', 'phone': '010-52176043'}, {'name': 'zhou ping, Postgraduate Student', 'role': 'CONTACT', 'email': 'hzyyzp@126.com', 'phone': '13261306969'}], 'overallOfficials': [{'name': 'Liu cun zhi, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beijing Hospital of Traditional Chinese Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Hospital of Traditional Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ping Zhou', 'investigatorAffiliation': 'Beijing Hospital of Traditional Chinese Medicine'}}}}