Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-01-08 @ 12:54 PM
Study NCT ID:
NCT06653959
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-23
First Post:
2024-10-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precision Transcranial Magnetic Stimulation for Patients With Post-stress Sleep Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'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': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-21', 'studyFirstSubmitDate': '2024-10-09', 'studyFirstSubmitQcDate': '2024-10-21', 'lastUpdatePostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pittsburgh sleep quality index (PSQI) scores from baseline to post-treatment', 'timeFrame': 'Baseline and treatment day 5', 'description': 'The Pittsburgh Sleep Quality Index, compiled in 1989 by Dr. Buysse, a psychiatrist at the University of Pittsburgh, and others. It is suitable for patients with sleep disorders to evaluate the quality of their sleep, as well as for the general population to assess the quality of their sleep. The scale consists of 9 questions, of which the first 4 are fill-in-the-blanks and the last 5 are multiple-choice (question 5 contains 10 sub-questions) Change = (treatment day 5 Score -Baseline Score).'}], 'secondaryOutcomes': [{'measure': 'Change in Posttraumatic Stress Disorder Check List for Diagnostic and Statistical Manual of Mental Disorders-5 scores from baseline to treatment day 5', 'timeFrame': 'Baseline and treatment day 5', 'description': 'Posttraumatic Stress Disorder Check List for Diagnostic and Statistical Manual of Mental Disorders-5（PCL-5） is a validated, self-reported instrument assessing PTSD symptom severity over the past week or month period .Possible scores range from 0 to 80 .\n\nChange = (treatment day 5 Score -Baseline Score).'}, {'measure': 'Change in Stanford Acute Stress Reaction Questionnaire (SASRQ) scores from baseline to treatment day 5', 'timeFrame': 'Baseline and treatment day 5', 'description': 'The Stanford Acute Stress Reaction Questionnaire (SASRQ) is a commonly used international instrument for assessing acute stress disorders. It consists of 5 dimensions, including alertness, dissociation, avoidance, re-experiencing, and impairment of social functioning, with a total of 30 items, ranging from "not experiencing" to "always experiencing". A total of 30 items, ranging from "no experience" to "always experience", were assigned a score of 0 to 5, with a total score of 0 to 150. The higher the total score, the more severe the acute stress disorder, with a score of ≥40 suggesting a moderate likelihood of acute stress disorder.\n\nChange = (treatment day 5 Score -Baseline Score).'}, {'measure': 'Change in Hamilton Depression Scale（HAMD-17）scores from baseline to treatment day 5 Score', 'timeFrame': 'Baseline and treatment day 5', 'description': 'Hamilton Depression Scale（HAMD-17） is a commonly used clinical evaluation standard for the severity of depressive symptoms. There are 17 items in total, which can be scored before and after treatment to evaluate the severity of the disease and the treatment effect.Possible scores range from 0 to 52 and the higher the score, the worse the symptom.\n\nChange = (treatment day 5 Score -Baseline Score).'}, {'measure': 'Change in Hamilton Anxiety Scale scores from baseline to treatment day 5 Score', 'timeFrame': 'Baseline and treatment day 5', 'description': 'Hamilton Anxiety Scale (HAMA）is suitable for assessing the severity of anxiety symptoms. It has 14 items and adopts a 5-level scoring method of 0-4 points.Possible scores range from 0 to 56 and the higher the score, the worse the symptom.\n\nChange = (treatment day 5 Score -Baseline Score).'}, {'measure': 'Change in Posttraumatic Stress Disorder Check List for Diagnostic and Statistical Manual of Mental Disorders-5 scores from baseline to 28 days after the end of treatment', 'timeFrame': 'Baseline and 28 days after the end of treatment', 'description': 'Posttraumatic Stress Disorder Check List for Diagnostic and Statistical Manual of Mental Disorders-5（PCL-5） is a validated, self-reported instrument assessing PTSD symptom severity over the past week or month period .Possible scores range from 0 to 80 .\n\nChange = (28 days after the end of treatment Score -Baseline Score).'}, {'measure': 'Change in Stanford Acute Stress Reaction Questionnaire (SASRQ) scores from baseline to 28 days after the end of treatment', 'timeFrame': 'Baseline and 28 days after the end of treatment', 'description': 'The Stanford Acute Stress Reaction Questionnaire (SASRQ) is a commonly used international instrument for assessing acute stress disorders. It consists of 5 dimensions, including alertness, dissociation, avoidance, re-experiencing, and impairment of social functioning, with a total of 30 items, ranging from "not experiencing" to "always experiencing". A total of 30 items, ranging from "no experience" to "always experience", were assigned a score of 0 to 5, with a total score of 0 to 150. The higher the total score, the more severe the acute stress disorder, with a score of ≥40 suggesting a moderate likelihood of acute stress disorder.\n\nChange = (28 days after the end of treatment Score -Baseline Score).'}, {'measure': 'Change in Hamilton Depression Scale（HAMD-17）scores from baseline to 28 days after the end of treatment', 'timeFrame': 'Baseline and 28 days after the end of treatment', 'description': 'Hamilton Depression Scale（HAMD-17） is a commonly used clinical evaluation standard for the severity of depressive symptoms. There are 17 items in total, which can be scored before and after treatment to evaluate the severity of the disease and the treatment effect.Possible scores range from 0 to 52 and the higher the score, the worse the symptom.\n\nChange = (28 days after the end of treatment Score -Baseline Score).'}, {'measure': 'Change in Hamilton Anxiety Scale scores from baseline to 28 days after the end of treatment', 'timeFrame': 'Baseline and 28 days after the end of treatment', 'description': 'Hamilton Anxiety Scale (HAMA）is suitable for assessing the severity of anxiety symptoms. It has 14 items and adopts a 5-level scoring method of 0-4 points.Possible scores range from 0 to 56 and the higher the score, the worse the symptom.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress, Psychological', 'Sleep Initiation and Maintenance Disorders', 'Transcranial Magnetic Stimulation']}, 'referencesModule': {'references': [{'pmid': '37664876', 'type': 'BACKGROUND', 'citation': 'Cai M, Zhu Y, Shanley MR, Morel C, Ku SM, Zhang H, Shen Y, Friedman AK, Han MH. HCN channel inhibitor induces ketamine-like rapid and sustained antidepressant effects in chronic social defeat stress model. Neurobiol Stress. 2023 Aug 19;26:100565. doi: 10.1016/j.ynstr.2023.100565. eCollection 2023 Sep.'}, {'pmid': '29679009', 'type': 'BACKGROUND', 'citation': 'Luo YJ, Li YD, Wang L, Yang SR, Yuan XS, Wang J, Cherasse Y, Lazarus M, Chen JF, Qu WM, Huang ZL. Nucleus accumbens controls wakefulness by a subpopulation of neurons expressing dopamine D1 receptors. Nat Commun. 2018 Apr 20;9(1):1576. doi: 10.1038/s41467-018-03889-3.'}, {'pmid': '25192980', 'type': 'BACKGROUND', 'citation': 'Brunelin J, Jalenques I, Trojak B, Attal J, Szekely D, Gay A, Januel D, Haffen E, Schott-Pethelaz AM, Brault C; STEP Group; Poulet E. The efficacy and safety of low frequency repetitive transcranial magnetic stimulation for treatment-resistant depression: the results from a large multicenter French RCT. Brain Stimul. 2014 Nov-Dec;7(6):855-63. doi: 10.1016/j.brs.2014.07.040. Epub 2014 Aug 7.'}, {'pmid': '27269205', 'type': 'BACKGROUND', 'citation': 'Blumberger DM, Maller JJ, Thomson L, Mulsant BH, Rajji TK, Maher M, Brown PE, Downar J, Vila-Rodriguez F, Fitzgerald PB, Daskalakis ZJ. Unilateral and bilateral MRI-targeted repetitive transcranial magnetic stimulation for treatment-resistant depression: a randomized controlled study. J Psychiatry Neurosci. 2016 Jun;41(4):E58-66. doi: 10.1503/jpn.150265.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind controlled study that recruited patients with insomnia problems after suffering a stressful event to undergo individualized transcranial magnetic stimulation', 'detailedDescription': 'This is a randomized, double-blind controlled study that will recruit patients who have experienced a stressful event and currently exhibit severe sleep problems for transcranial magnetic stimulation. They will be randomly assigned to the trial and control groups and will receive 5 consecutive days of continuous theta-wave stimulation, and before and after the treatment they will be assessed on clinical scales and undergo magnetic resonance examinations as well as sleep monitoring.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Be between the ages of 18 and 60 (both 18 and 60) and of any gender;\n2. Experienced a severe traumatic event;\n3. Stanford Acute Stress Reaction Questionnaire (SASRQ) ≥40 points;\n4. PSQI \\> 7 points;\n5. Good compliance and willingness to undergo this therapy.\n\nExclusion Criteria:\n\n1. Sleep disorders that can be explained by a primary illness;\n2. Concurrent psychotherapy;\n3. Those with contraindications to magnetic resonance examination and transcranial magnetic stimulation therapy;\n4. Combined with serious cardiovascular, hepatic, renal, digestive, hematopoietic system and other primary diseases.'}, 'identificationModule': {'nctId': 'NCT06653959', 'briefTitle': 'Precision Transcranial Magnetic Stimulation for Patients With Post-stress Sleep Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Safety and Efficacy Study of Precise Transcranial Magnetic Stimulation Based on vlPFC-VTA Individualized Functional Connectivity Localization for the Treatment of Post-stress Sleep Disorders', 'orgStudyIdInfo': {'id': 'KY20242082'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'active Transcranial Magnetic Stimulation', 'description': 'The most relevant site of functional connectivity between vlPFC-VTA will be targeted for continuous theta burst stimulation', 'interventionNames': ['Device: active Transcranial Magnetic Stimulation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'sham Transcranial Magnetic Stimulation', 'description': 'The most relevant site of functional connectivity between vlPFC-VTA will be targeted for sham continuous theta burst stimulation', 'interventionNames': ['Device: sham Transcranial Magnetic Stimulation']}], 'interventions': [{'name': 'active Transcranial Magnetic Stimulation', 'type': 'DEVICE', 'description': "Based on each individual's MRI data, individualized stimulation targets will be found, and then this will be used for stimulation for 5 consecutive days.", 'armGroupLabels': ['active Transcranial Magnetic Stimulation']}, {'name': 'sham Transcranial Magnetic Stimulation', 'type': 'DEVICE', 'description': "Based on each individual's MRI data, individualized stimulation targets will be found, and then this will be used for sham stimulation for 5 consecutive days.", 'armGroupLabels': ['sham Transcranial Magnetic Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710000', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'contacts': [{'name': 'zhao, PhD', 'role': 'CONTACT', 'email': 'zhangyc_2022@126.com', 'phone': '18792536506'}], 'facility': 'Xijing Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'yaochi Zhang', 'role': 'CONTACT', 'email': 'a18294037117@163.com', 'phone': '18294037117'}], 'overallOfficials': [{'name': 'Min Cai, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xijing Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}