RecruitingACTRN12619000182190

Brain stimulation for the improvement of thinking and memory skills in Mild Cognitive Impairment

A longitudinal investigation of the neurophysiological changes related to cognitive performance and the effects of neuromodulation in Mild Cognitive Impairment

Sponsor

Monash University

Enrollment

100 participants

Start Date

Nov 22, 2018

Study Type

Interventional

Conditions

Memory difficulties Mild Cognitive Impairment

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.

Eligibility

Sex: Both males and femalesMin Age: 50 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

Mild Cognitive Impairment (MCI) is a stage between normal ageing and dementia where a person notices some changes in memory or thinking, but can still function independently. Some people with MCI go on to develop Alzheimer's disease, while others do not — and understanding why is a major question in neuroscience. This study explores whether non-invasive brain stimulation using transcranial Alternating Current Stimulation (tACS) — where a gentle electrical current is applied to the scalp — can improve thinking skills and potentially slow the progression of MCI over a three-year period. Participants receive either active tACS or a sham (inactive) stimulation each year over three years, alongside brain assessments and cognitive testing. The study also examines what lifestyle and psychosocial factors influence how MCI changes over time. You may be eligible if you are aged 50 to 70, have been diagnosed with amnestic Mild Cognitive Impairment (memory-based MCI), can complete cognitive testing in English, and are able to provide informed consent. You are not eligible if you have a history of substance dependence, significant psychiatric or neurological illness, are pregnant, are taking benzodiazepines, or have contraindications to brain stimulation (such as a pacemaker or epilepsy).

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 cou

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.