Alzheimer Disease
Conditions
Keywords
transmagnetic stimulation, functional MRI guided theta burst stimulation, intermittent theta burst stimulation
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. 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.
Interventions
DEVICEIntermittent theta burst stimulation active coil
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
DEVICESham coil
MagVenture TMS Therapy sham coil
Sponsors
HealthPartners Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
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 Status Examination (MMSE) \>24 * Clinical Dementia Rating (CDR) 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 resting state-function magnetic resonance imaging (rs-fMRI) * Contraindication of rs-fMRI due to implants or metal * Seizure disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of TBS on cognition between and within subjects using Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS) | baseline, 7 weeks | 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. |
Countries
United States
Outcome results
None listed