A Randomised Controlled Trial of the Theta Burst Stimulation Melbourne Protocol for Alzheimer's Disease (The TRAM Protocol)

This research is investigating whether a form of non-invasive brain stimulation, known as Transcranial Magnetic Stimulation (TMS), can improve the symptoms of Alzheimer’s disease, such as difficulties with learning and memory. TMS involves magnetically stimulating brain cells using a handheld device placed on the head. TMS has been approved as a treatment for depression in Australia and this study has received approval to investigate the potential effects in Alzheimer’s disease. 

The research team are investigating a specific form of TMS, known as Theta Burst Stimulation (TBS). TBS is a safe and non-invasive technique which uses magnetic pulses to alter brain activity. Treatment involves attending a clinic to receive TBS to four areas of the brain, with treatment being delivered by a small coil placed on the head. The research team will assess the effects of TBS on brain activity and symptoms of Alzheimer's disease. 

Participation in this study will involve receiving a treatment course of TBS and attending study appointments to assess Alzheimer’s disease symptoms and brain activity. TBS treatment will consist of a total of 36 treatment sessions over a 12-week period. Specifically, participants will have 5 treatments per week (Monday-Friday) for the first 6 weeks, and then 1 session per week for the following 6 weeks. Each treatment appointment will take approximately 30-minutes.

To investigate how the treatment affects brain activity and symptoms of Alzheimer’s disease, assessments will be conducted throughout the treatment period, and participants will have follow-up appointments at 3-, 6-, and 12-months after the treatment course has ended. During these appointments the research team will conduct tests and ask questions to assess the symptoms of Alzheimer's disease. As a part of the study, participants will be required to have a close other to attend some appointments and answer questions so that the research team can obtain their impressions of symptoms. 

This is a placebo-controlled trial, which means that participants will be randomly allocated to receive either the active (i.e., real) or placebo (i.e., fake) treatment. However, all participants will receive active TBS treatment at some point, as those who received placebo treatment in the first part of the trial will be offered it during the six-month follow-up.

All TBS treatments and study appointments will be completed in Melbourne, Victoria. In total, participation in the study may last up to 1 year and 3 months.

Participants who meet the following criteria may be eligible to participate:
- Have been diagnosed with Alzheimer’s disease 
- Be aged between 50 to 85 years
- Have no history of epilepsy
- Be able to attend regular study appointments in Melbourne
- Have a close other who is able to attend appointments with them.