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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alzheimer Disease
- Sponsor
- HealthPartners Institute
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Change in Connectivity Measure of the TGd Parcellations.
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change in Connectivity Measure of the TGd Parcellations.
Time Frame: 9 weeks
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.