Transmagnetic Stimulation Pilot in Early Stage Alzheimer's Disease
A Single Arm Study of Resting State Functional Magnetic Resonance Imaging (Rs-fMRI)-Guided Theta Burst Stimulation (TBS) in Early-Stage Alzheimer's Disease (AD)
1 other identifier
interventional
15
1 country
1
Brief Summary
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. In combination with resting state functional MRI (rs-fMRI), transcranial magnetic stimulation (TMS) with intermittent theta burst stimulation (iTBS) offers a non-invasive alternative to pharmacotherapy in persons with AD. We propose a pilot trial using rs-fMRI to target dysfunctional LSBNs in early stage AD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable alzheimer-disease
Started Jun 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2022
CompletedFirst Posted
Study publicly available on registry
March 23, 2022
CompletedStudy Start
First participant enrolled
June 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 7, 2023
CompletedResults Posted
Study results publicly available
January 7, 2025
CompletedJanuary 7, 2025
November 1, 2023
1.4 years
March 14, 2022
November 27, 2024
December 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Connectivity Measure of the TGd Parcellations.
Assessed by calculating the difference and standard deviation between follow-up and baseline of number of abnormal connections of the TGd parcellation. Range: 0-378. There are 378 possible connections of the parcellation. Higher values indicate more abnormal connections of the TGd parcellation pre and post-treatment. The change in the number of abnormal connections of the parcellation is reported.
9 weeks
Study Arms (1)
Intermittent theta burst stimulation
EXPERIMENTALAll subjects will receive treatment with intermittent theta burst stimulation (iTBS). There will be a total of 5 treatments over a 2-week period. All subjects will receive iTBS to the right TGd 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 10-12 weeks.
Interventions
MagVenture TMS Therapy 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
Eligibility Criteria
You may qualify if:
- Established diagnosis of Mild Cognitive Impairment (MCI)/mild AD
- Evidence for Central Nervous System (CNS) amyloidosis (e.g., Amyloid positron emission tomography (PET) or cerebrospinal fluid (CSF) biomarkers consistent with AD)
- Prior brain imaging performed
- Mini-Mental State Examination (MMSE) \>24
- Clinical Dementia Rating (CDR) Scale 0.5-1
- Stable dose of cholinesterase inhibitors and memantine for at least one month
- Subjects are between 40-90 years of age
You may not qualify if:
- Non-AD dementia including, but not limited to, Lewy body dementia, frontotemporal dementia, vascular dementia, Jakob-Creutzfeldt disease, etc.
- Inability to tolerate rs-fMRI
- Contraindication of rs-fMRI due to implants or metal
- Seizure disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
HealthPartners Neuroscience Center
Saint Paul, Minnesota, 55130, United States
Related Publications (1)
Kashyap B, Hanson LR, Gustafson SK, Barclay T, Howe CM, Sherman SJ, Hungs M, Rosenbloom MH. Open label pilot of personalized, neuroimaging-guided theta burst stimulation in early-stage Alzheimer's disease. Front Neurosci. 2024 Dec 9;18:1492428. doi: 10.3389/fnins.2024.1492428. eCollection 2024.
PMID: 39717698DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bhavani Kashyap, MBBS, PhD
- Organization
- HealthPartners Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Bhavani Kashyap, MBBS, PhD
HealthPartners Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2022
First Posted
March 23, 2022
Study Start
June 17, 2022
Primary Completion
November 7, 2023
Study Completion
November 7, 2023
Last Updated
January 7, 2025
Results First Posted
January 7, 2025
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share
No identifiable data will be shared with other researchers.