Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:27 AM
Study NCT ID:
NCT07346794
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-16
First Post:
2025-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Underlying Neural Mechanism of TMS in Improving the Imbalance of "Microbiota-brain-gut Axis" in Alzheimer 's Disease Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-08', 'studyFirstSubmitDate': '2025-12-16', 'studyFirstSubmitQcDate': '2026-01-08', 'lastUpdatePostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MoCA score', 'timeFrame': 'Pre-intervention, Periprocedural, and Post-intervention at 1/3/6/12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Alzheimer's Disease", 'rTMS Stimulation']}, 'descriptionModule': {'briefSummary': 'What is this study about? This study focuses on Alzheimer\'s Disease (AD), a common neurodegenerative disease that affects memory, thinking, and daily life. We aim to explore whether a non-invasive treatment called Repetitive Transcranial Magnetic Stimulation (rTMS) can improve AD symptoms by regulating the "gut-brain-intestine axis" - a connection between gut bacteria, the brain, and the intestines.\n\nWho can participate?\n\n* \\*\\*AD patients\\*\\*: Aged 50-80, diagnosed with mild to moderate AD (MMSE score 18-27, MoCA score 10-26), with stable condition for at least 6 months, and able to cooperate with tests and treatment.\n* \\*\\*Healthy controls\\*\\*: Aged 50-80, with normal cognitive function (MMSE ≥28, MoCA ≥27), no AD family history, and matched in age and gender with AD patients.\n\nThose with epilepsy, severe mental illness, recent use of antibiotics/probiotics, or inability to complete MRI scans are not eligible.\n\nWhat will participants experience?\n\n* \\*\\*AD patients\\*\\*: Will be randomly divided into two groups. Both groups will receive 4 weeks of treatment (5 days/week) with a helmet-like device. One group gets real rTMS (safe magnetic stimulation to the brain), and the other gets sham stimulation (no effective magnetic field, but same sound/feel).\n* \\*\\*Healthy controls\\*\\*: No treatment, but will complete the same tests as AD patients.\n* \\*\\*Tests during the study\\*\\*: Cognitive assessments (memory, thinking skills via questionnaires), stool/blood sample collection (to check gut bacteria and body markers), and MRI scans (to look at brain structure/function) at baseline, 1 month, 3 months, 6 months, and 1 year.\n\nWhat are the potential benefits?\n\n* Free rTMS treatment (for AD patients), free MRI scans (valued at 700 RMB), and a 200 RMB subsidy.\n* Free health checks (gut bacteria analysis, metabolic tests) and cognitive evaluations to understand personal health status.\n* Contribution to developing new AD treatments that may help future patients.\n\nIs it safe? rTMS is a clinically proven safe technique. Possible mild side effects (headache, scalp irritation) usually go away on their own. Sample collection (stool/blood) and MRI scans are non-invasive or minimally invasive. A professional team will monitor participants throughout to handle any issues.\n\nFor healthcare providers This is a multicenter, randomized, double-blind sham-controlled study (200 AD patients, 200 healthy controls). The primary goal is to explore rTMS\'s mechanism via the gut-brain-intestine axis, with MoCA score changes (6 months post-treatment) as the main outcome. It integrates multi-omics and neuroimaging data to provide evidence for AD\'s non-drug treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dementia Patients: Conformed to internationally recognized diagnostic criteria for dementia (e.g., DSM-5, NINCDS-ADRDA)\n* Diagnosed through clinical evaluation, neuropsychological scale assessments, and relevant examinations\n* Aged ≥50 years and residing in Nanchang, Jiangxi\n* With dementia-negative family history, no severe psychiatric or neurological disorders\n* No history of major systemic diseases.\n\nExclusion Criteria:\n\n* Unable to cooperate with all required examinations, intervention procedures, and sample collection during the study.'}, 'identificationModule': {'nctId': 'NCT07346794', 'briefTitle': 'The Underlying Neural Mechanism of TMS in Improving the Imbalance of "Microbiota-brain-gut Axis" in Alzheimer \'s Disease Population', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Nanchang University'}, 'officialTitle': 'The Underlying Neural Mechanism of TMS in Improving the Imbalance of "Microbiota-brain-gut Axis" in Alzheimer \'s Disease Population', 'orgStudyIdInfo': {'id': 'TMS82460341'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients undergoing treatment', 'interventionNames': ['Procedure: TMS']}, {'type': 'NO_INTERVENTION', 'label': 'No treatment', 'description': 'The sham DLPFC-rTMS group will receive stimulation via a single helmet equipped with a sham coil, which is designed to induce similar noise and scalp sensations under the same parameters as the active stimulation group.'}], 'interventions': [{'name': 'TMS', 'type': 'PROCEDURE', 'description': 'For the repetitive transcranial magnetic stimulation (rTMS) intervention, the dorsolateral prefrontal cortex (DLPFC) is selected as the stimulation target, with a stimulation frequency of 10 Hz; the intervention consists of 20 stimulation trains per day, 5 days per week, using a coil with a diameter of 9 cm, at an intensity of 80% of the motor threshold (minimum single-pulse intensity: 50 μV); each stimulation train lasts for 10 seconds, with an interval of 25 seconds between trains, and 20 trains per day totaling 2000 pulses. The treatment is administered once daily, five times a week, for 4 consecutive weeks, resulting in a total of 20 to 30 sessions, and the traditional "5-centimeter" method is adopted for localizing the DLPFC stimulation target.', 'armGroupLabels': ['Patients undergoing treatment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Xijian Dai, Doctor', 'role': 'CONTACT', 'email': 'daixjdoctor@126.com', 'phone': '+86 13755756959'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Nanchang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}