Theta Burst Stimulation for Mild to Moderate Alzheimer's disease. - Trial ANZCTR12623000668606

Timeline & Enrollment

Primary Outcome

Functional Connectivity as measured using resting state functional Magnetic Resonance Imaging (rs-fMRI). ;; The Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog). ;; Clinical Dementia Rating Sum of Boxes (CDR-SB, composite scale for cognition and function)

Summary

Memory problems in Alzheimer's disease (AD) are linked to disruptions in the connections between brain regions. In a recent study we demonstrated that Theta Burst Stimulation (TBS), a type of brain stimulation, can alter the connections between brain regions and improve memory in patients with AD. We now propose a randomised controlled trial to examine whether TBS can lead to lasting improvements in 168 individuals with mild to moderate AD. We plan to compare active vs sham (placebo) TBS. Treatment will involve a 6-weeks of daily treatment (Monday – Friday) followed by a 6-weeks of once-weekly treatment. Treatment will be individualised for each participant. This means that stimulation will be based on the individual participant’s brain activity, recorded using electroencephalography (EEG). Additionally, the treatment will be delivered to four areas of the brain, the locations of which will be identified for each participant using a brain scan: a functional magnetic resonance imaging (fMRI) scan. We will examine changes in brain activity, memory and other symptoms of AD before and after treatment, as well as at 3, 6, and 12 month follow ups. If effective, individualised TBS could be used as a new therapy for AD.

ICD-10 Classifications