Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:06 AM
Study NCT ID:
NCT07340268
Status:
RECRUITING
Last Update Posted:
2026-02-04
First Post:
2026-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Transcranial Current Stimulation on Insomnia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-03', 'studyFirstSubmitDate': '2026-01-04', 'studyFirstSubmitQcDate': '2026-01-13', 'lastUpdatePostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in global blood-oxygen-level-dependent (gBOLD) signal amplitude', 'timeFrame': '2 weeks and 3 months', 'description': 'The amplitude of the global blood-oxygen-level-dependent (gBOLD) signal was derived from resting-state functional MRI and reflects the overall magnitude of spontaneous brain activity. Unit of Measure: Z-score'}, {'measure': 'Change in resting-state functional connectivity strength', 'timeFrame': '2 weeks and 3 months', 'description': 'Resting-state functional connectivity strength was calculated as the correlation coefficient between predefined brain regions based on functional magnetic resonance imaging data.'}, {'measure': 'Change in amplitude of low-frequency fluctuations', 'timeFrame': '2 weeks and 3 months', 'description': 'Amplitude of low-frequency fluctuations was calculated from resting-state fMRI to quantify spontaneous neural activity.'}, {'measure': 'Change in regional homogeneity', 'timeFrame': '2 weeks and 3 months', 'description': 'Regional homogeneity was used to assess the synchronization of local spontaneous brain activity'}, {'measure': 'Change in phase difference of dynamic cerebral autoregulation', 'timeFrame': '2 weeks and 3 months', 'description': 'Dynamic cerebral autoregulation was assessed using the phase difference between cerebral blood flow velocity and arterial blood pressure fluctuations. Larger phase differences indicate better autoregulatory function.'}, {'measure': 'Change in gain of dynamic cerebral autoregulation', 'timeFrame': '2 weeks and 3 months', 'description': 'Gain represents the magnitude of cerebral blood flow velocity changes in response to blood pressure fluctuations, with lower gain values indicating more effective autoregulation.'}], 'secondaryOutcomes': [{'measure': 'the score of Insomnia Severity Index scale', 'timeFrame': '2 weeks and 3 months', 'description': 'The total score ranges from 0 to 28, and a higher score indicates higher levels of insomnia severity. A score of 8 or greater is the cut point for clinically possible insomnia'}, {'measure': 'the score of 14-item Hamilton anxiety rating scale', 'timeFrame': '2 weeks and 3 months', 'description': 'The total score ranges from 0 to 56, and a higher score indicates higher levels of anxiety symptoms. A score of 7 or greater is the cut point for clinically possible anxiety'}, {'measure': 'the score of 17-item Hamilton depression rating scale', 'timeFrame': '2 weeks and 3 months', 'description': 'tThe total score ranges from 0 to 52, and a higher score indicates higher levels of depression symptoms. A score of 7 or greater is the cut point for clinically possible depression symptom'}, {'measure': 'Change in plasma corticotropin-releasing factor (CRF) level', 'timeFrame': '2 weeks and 3 months', 'description': 'Plasma corticotropin-releasing factor (CRF) concentration was measured as a biomarker of hypothalamic-pituitary-adrenal (HPA) axis activity. Higher levels indicate increased neuroendocrine stress response. Unit of Measure: pg/mL'}, {'measure': 'Change in plasma cortisol level', 'timeFrame': '2 weeks and 3 months', 'description': 'Plasma cortisol concentration was assessed as an indicator of hypothalamic-pituitary-adrenal (HPA) axis function. Higher levels reflect increased physiological stress response. Unit of Measure: μg/dL'}, {'measure': 'Change in serum interleukin-6 level', 'timeFrame': '2 weeks and 3 months', 'description': 'Serum interleukin-6 concentration was measured as a marker of systemic inflammation. Higher levels indicate greater inflammatory activity. Unit of Measure: pg/mL'}, {'measure': 'Change in serum brain-derived neurotrophic factor level', 'timeFrame': '2 weeks and 3 months', 'description': 'Serum brain-derived neurotrophic factor concentration was measured as a biomarker associated with neuroplasticity and neuronal function. Higher levels indicate enhanced neurotrophic activity. Unit of Measure: pg/mL'}, {'measure': 'Change in total sleep time (TST) measured by polysomnography', 'timeFrame': '2 weeks and 3 months'}, {'measure': 'Change in sleep onset latency (SOL) measured by polysomnography', 'timeFrame': '2 weeks and 3 months'}, {'measure': 'Change in wake after sleep onset (WASO) measured by polysomnography', 'timeFrame': '2 weeks and 3 months'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Insomnia, Psychophysiological']}, 'descriptionModule': {'briefSummary': 'Effect of transcranial current stimulation on insomnia disorder', 'detailedDescription': 'Insomnia disorder represents a prevalent clinical challenge, transcranial current stimulation has emerged as a promising noninvasive therapeutic approach; however, its specific effects on neurophysiological mechanisms underlying sleep-related brain structure and functional change, and neurobiological change remain unclear.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of insomnia disorder\n* Cooperate to complete the questionnaire surveys\n\nExclusion Criteria:\n\n* Presence of mental disorders\n* Current use of central nervous system stimulants\n* Use of analgesics,sedatives or hypnotic medications, theophylline preparations, steroid medications\n* Alcohol abuse or regular alcohol consumption\n* Diagnosis of other sleep disorders, including obstructive sleep apnea, rapid eye movement sleep behavior disorder, or restless legs syndrome\n* Sleep disorders secondary to organic diseases, such as epilepsy, diabetes, or renal failure\n* Shift work or irregular work schedules that disrupt normal circadian rhythms\n* Use of medications affecting central nervous system function within the past one month\n* Recent sleep-related confounding behaviors within the past two weeks, including staying up late, alcohol consumption, or smoking\n* Presence of organic brain lesions on head MRI and contraindications to MRI examination'}, 'identificationModule': {'nctId': 'NCT07340268', 'briefTitle': 'The Effects of Transcranial Current Stimulation on Insomnia', 'organization': {'class': 'OTHER', 'fullName': 'The First Hospital of Jilin University'}, 'officialTitle': 'The Effects of Transcranial Current Stimulation on Insomnia', 'orgStudyIdInfo': {'id': 'TCS-V01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'active transcranial current stimulation', 'description': '14 daily 20-min, 1.1-mA sessions of active or sham transcranial current stimulation, at the beginning and end of treatment, there is a 30 second period of current fading in and out', 'interventionNames': ['Device: transcranial current stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham transcranial current stimulation', 'description': 'only wore the device and had no stimulation', 'interventionNames': ['Device: Sham stimulation']}], 'interventions': [{'name': 'transcranial current stimulation', 'type': 'DEVICE', 'description': 'consecutive daily 20-min, 1.1-mA sessions', 'armGroupLabels': ['active transcranial current stimulation']}, {'name': 'Sham stimulation', 'type': 'DEVICE', 'description': 'only wore the device and had no stimulation', 'armGroupLabels': ['sham transcranial current stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130021', 'city': 'Ch’ang-ch’un', 'state': 'Jilin', 'status': 'COMPLETED', 'country': 'China', 'facility': 'the First Hospital of Jilin University', 'geoPoint': {'lat': 42.74694, 'lon': 126.24667}}, {'zip': '130021', 'city': 'Ch’ang-ch’un', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zan Wang Prof, PhD', 'role': 'CONTACT', 'email': 'wnagzan@jlu.edu.cn', 'phone': '+86-13843025938'}], 'facility': 'the First Hospital of Jilin University', 'geoPoint': {'lat': 42.74694, 'lon': 126.24667}}], 'centralContacts': [{'name': 'Zan Wang, MD, PhD', 'role': 'CONTACT', 'email': 'wangzan@jlu.edu.cn', 'phone': '+86 88782678'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zan Wang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Sleep Center Director', 'investigatorFullName': 'Zan Wang', 'investigatorAffiliation': 'The First Hospital of Jilin University'}}}}