Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:54 AM
Study NCT ID:
NCT06817902
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-04
First Post:
2025-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TMS Pilot in Early AD II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2025-02-03', 'studyFirstSubmitQcDate': '2025-02-07', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of TBS on cognition between and within subjects using Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS)', 'timeFrame': 'baseline, 7 weeks', 'description': 'Average change of RBANS total score in TMS arm compared to the average change in RBANS total score in the sham arm. Range \\[-160 to 160\\]. Positive comparison of TMS arm to sham arm indicates increased cognitive scores in TMS arm.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['transmagnetic stimulation', 'functional MRI guided theta burst stimulation', 'intermittent theta burst stimulation'], 'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': "Alzheimer's disease (AD) is a progressive neurodegenerative condition affecting 6.2 million individuals in the United States, resulting in an annual cost of care of $305 billion. AD is functionally characterized by progressive degeneration of large-scale brain networks (LSBNs), including the default mode network (DMN) presumably from the deposition of amyloid plaques and neurofibrillary tangles. Available FDA-approved medications for AD such as donepezil and memantine offer limited benefit and modest impact on quality of life. Transcranial magnetic stimulation (TMS) with intermittent theta burst stimulation (iTBS) offers a non-invasive alternative to pharmacotherapy in persons with AD. We propose a case series study to compare sham with iTBS."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Established diagnosis of Mild cognitive impairment (MCI)/mild AD\n* Evidence for central nervous system (CNS) amyloidosis (e.g., Amyloid Positron Emission Tomography (PET) or Cerebrospinal fluid (CSF) biomarkers consistent with AD)\n* Prior brain imaging performed\n* Mini Mental Status Examination (MMSE) \\>24\n* Clinical Dementia Rating (CDR) 0.5-1\n* Stable dose of cholinesterase inhibitors and memantine for at least one month\n* Subjects are between 40-90 years of age\n\nExclusion Criteria:\n\n* Non-AD dementia including, but not limited to, Lewy body dementia, frontotemporal dementia, vascular dementia, Jakob-Creutzfeldt disease, etc.\n* Inability to tolerate resting state-function magnetic resonance imaging (rs-fMRI)\n* Contraindication of rs-fMRI due to implants or metal\n* Seizure disorder'}, 'identificationModule': {'nctId': 'NCT06817902', 'briefTitle': 'TMS Pilot in Early AD II', 'organization': {'class': 'OTHER', 'fullName': 'HealthPartners Institute'}, 'officialTitle': "A Preliminary Sham-Controlled Theta Burst Stimulation (TBS) Study in Early-Stage Alzheimer's Disease (AD)", 'orgStudyIdInfo': {'id': 'A21-251-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intermittent theta burst stimulation', 'description': 'Subjects will receive treatment with intermittent theta burst stimulation (iTBS) with the active coil. There will be a total of 5 treatments over a 2-week period. All subjects will receive iTBS to the 8Av region. TBS treatment will also be provided for two additional sites within the large-scale brain networks (LSBNs) that is found to contain the greatest number of connectivity anomalies. Total participation will be 6-9 weeks.', 'interventionNames': ['Device: Intermittent theta burst stimulation active coil']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham device', 'description': 'Subjects will receive treatment with sham coil. There will be a total of 5 treatments over a 2-week period. Coil will be placed over the same region as the experimental group. Total participation will be 6-9 weeks. An open-label extension will be offered to participants that received the sham (control) treatment without further data collection.', 'interventionNames': ['Device: Sham coil']}], 'interventions': [{'name': 'Intermittent theta burst stimulation active coil', 'type': 'DEVICE', 'otherNames': ['Transmagnetic stimulation', 'MagVenture'], 'description': 'MagVenture TMS Therapy active coil with theta burst stimulation. Resting motor threshold: 80%; Number of pulses per session: 1200 pulses; Inter-train interval: 8 seconds; Pulse frequency in burst: 50 Hertz', 'armGroupLabels': ['Intermittent theta burst stimulation']}, {'name': 'Sham coil', 'type': 'DEVICE', 'otherNames': ['MagVenture'], 'description': 'MagVenture TMS Therapy sham coil', 'armGroupLabels': ['Sham device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55130', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'HealthPartners Neuroscience Center', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], 'overallOfficials': [{'name': 'Bhavani Kashyap, MBBS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HealthPartners Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No identifiable data will be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HealthPartners Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}