None listed
Conditions
Brief summary
There are many factors which are thought to contribute to the ability to maintain good brain health, including genetics, psychosocial and environmental factors. In addition, recent research has indicated that it may be possible to induce, or promote, brain health using non-invasive brain stimulation - namely transcranial Alternating Current Stimulation (tACS). Therefore, the purpose of this project is to investigate brain activity that is related to cognitive performance (i.e. thinking skills) in people with mild cognitive impairment. We will conduct these investigations a number of times over a three-year period to allow us to look at any changes that may occur in brain activity and cognitive performance. We will also be looking at any psychosocial and environmental factors that might contribute to changes in brain activity and cognitive performance. Finally, we will also investigate the effects of tACS on brain activity and cognition over the same period of time. Overall, this project aims to help provide a better understanding of the reasons why some people with MCI go on to develop Alzheimer’s, whilst others do not, and ultimately help in the development of early intervention treatments for Alzheimer’s disease. It is hypothesised that participants receiving active treatment will improve cognitive function, enhance brain activity, and strengthen functional brain connectivity after each yearly treatment course compared to those who undergo sham treatment. It is also hypothesised that there will be a lower conversion from MCI to Alzheimer’s disease in individuals receiving the active treatment over the three-year period, compared to those receiving the sham treatment. Finally, it is hypothesised that biopsychosocial factors will influence pathophysiological changes in people with MCI over time.
Interventions
Transcranial alternating current stimulation (tACS) involves the application of a weak alternating electrical current to the scalp to non-invasively increase cortical excitability.
A stimulation course of active gamma-tACS at 40Hz will be applied to the left prefrontal cortex at 1mA for 20-minutes per treatment during two Acute Phases (4 weeks) of treatment. Each Acute Phase is separated by a period of 6 months. . This treatment sequence will be repeated each year for a total of three years. Pa
Transcranial alternating current stimulation (tACS) involves the application of a weak alternating electrical current to the scalp to non-invasively increase cortical excitability. A stimulation course of active gamma-tACS at 40Hz will be applied to the left prefrontal cortex at 1mA for 20-minutes per treatment during two Acute Phases (4 weeks) of treatment. Each Acute Phase is separated by a period of 6 months. . This treatment sequence will be repeated each year for a total of three years. Participants will self-administer treatments in their own home following supervised training at the Monash Alfred Psychiatry research centre. Treatment adherence will be monitored using device analytics.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
(1) Meet criteria for amnestic-Mild Cognitive Impairment as defined by the International working group on mild cognitive impairment; (2) are competent to consent based on their ability to provide a spontaneous narrative description of the key elements of the study, as assessed by a clinical staff member independent of the research project; (3) are between the ages of 50 and 70; (4) are able to participate in cognitive testing in English.
Exclusion criteria
(1) Have a DSM-IV history of substance abuse or dependence in the last 6 months; (2) have a concomitant major and unstable medical, psychiatric or neurological illness; (3) are pregnant, (4) are currently taking any medication shown to interfere with the effects of stimulation; namely benzodiazepines; or (5) have any contraindications to brain stimulation as assessed using the TMS/tACS safety screen.
Outcome results
None listed