ANZCTR12623000668606

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

A Randomised Controlled Trial of individualised Theta Burst Stimulation on Functional Connectivity and Symptom Severity for Mild to Moderate Alzheimer's disease.
Bionics Institute of Australia·Not Applicable·Australian New Zealand Clinical Trials Registry·device·Device trialNot yet recruiting
Study focus
Disease/Condition
Alzheimer's Disease
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Bionics Institute of Australia
Location
Australia
Timeline & enrollment
Phase
Not Applicable
Start date
Jun 26, 2023
End date
May 29, 2028
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
Alzheimer diseaseAlzheimer disease, unspecifiedOther Alzheimer diseaseDementia in Alzheimer diseaseDementia in Alzheimer disease, unspecified
Data source
Registry
Australian New Zealand Clinical Trials Registry
Trial ID
ANZCTR12623000668606
Type
Device Trial
About this record

Access comprehensive clinical trial information for ANZCTR12623000668606 through Pure Global AI's free database. This Not Applicable trial is sponsored by Bionics Institute of Australia and is currently Not yet recruiting. The study focuses on Alzheimer's Disease.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to Australian New Zealand Clinical Trials Registry data, helping medical device and pharmaceutical companies navigate clinical research efficiently.