Alzheimer's disease (AD) is a neurodegenerative disorder characterized by progressive cognitive dysfunction and behavioral impairment. It is currently the most common type of dementia in the old age. At present, the clinical treatment of Alzheimer's disease is expensive and has side effects, so it is very important to explore new methods of treatment for AD. Investigators designed a prospective, randomized, double-blinded and placebo-controlled trial to investigate the effect of transcranial alternating current stimulation (tACS) on cognitive function in AD patients and to assess the biological effectiveness of the treatment.
As the population is aging, there is an urgent need to develop new methods of treatment for AD. Noninvasive neuro-regulation is a new technique in treating neuropsychiatric diseases. It include transcranial magnetic stimulation, traditional transcranial direct current stimulation, traditional transcranial alternating current stimulation and etc. Previously, conventional transcranial direct current stimulation had shown inconsistent results in the treatment for AD. This may be related to the low current density of traditional electrical stimulation in deep brain areas, such as hippocampus and amygdala, and leading to poor stimulation effect. Compared with the traditional transcranial electrical stimulation technology, the high intensity tACS greatly improves the current intensity, so that the electric field intensity to the deep brain nucleus during stimulation is greatly increased, and it avoids side effects such as burning sensation. Therefore, it could be used for AD patients. However, there are few clinical studies on high intensity tACS on AD, so investigators designed a randomized double-blinded placebo-controlled trial to explore the effect of high-current tACS on AD. At the same time, multimodal functional brain imaging before and after treatment will be used to compare the changes of brain function activation and cerebral hemodynamics in AD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Real tACS is an emerging noninvasive neuro-regulation technique that applies a specific frequency of stimulation and a specific intensity of weak current to the brain by means of electrodes placed in the skull.
Transcranial alternating current stimulation (sham-stimulation) is an emerging noninvasive neuro-regulation technique that applies a specific frequency of stimulation and a specific intensity of a weak current to the brain by means of electrodes placed in the skull. The subjects felt the same as the real stimulus when receiving the sham-stimulus treatment, but the sham-stimulus did not have the current stimulation.
Cognitive appraisal
A series of cognitive functions such as verbal function and visuospatial functions will be evaluated by Clock drawing test (maximum score =4, minimum score =0, the higher the better) and Boston Naming Test (maximum score =30, minimum score =0, the higher the better) ect.
Time frame: A total of 5 times will be measured, before the treatment, immediately after the treatment, 1-, 3- and 6-month follow-ups.
Global Cognitive appraisal
Overall cognitive function will be assessed through Clinical Dementia Rating(maximum score =3, minimum score =0, the higher the better) and Minimum Mental State Examination(maximum score =30, minimum score =0, the higher the better) ect.
Time frame: A total of 5 times will be measured, before the treatment, immediately after the treatment, 1-, 3- and 6-month follow-ups.
Psychobehavioral assessment
The mental and behavioral states of the patients will be evaluated by Neuropsychiatric Inventory(maximum score =144, minimum score =0, the lower the better) and Hamilton's Depression Scale (maximum score =68, minimum score =0, the lower the better) ect.
Time frame: A total of 5 times will be measured, before the treatment, immediately after the treatment, 1-, 3- and 6-month follow-ups.
Near-infrared spectroscopy
The brain function of the patients before and after treatment will be assessed by near infrared functional brain imaging
Time frame: A total of 5 times will be measured, before the treatment, immediately after the treatment, 1-, 3- and 6-month follow-ups.
Event related potential measurement
Event related potential indicators will be evaluated before and after treatment by electroencephalogram.
Time frame: A total of 5 times will be measured, before the treatment, immediately after the treatment, 1-, 3- and 6-month follow-ups.
Peripheral blood biomarkers
Peripheral blood biomarkers such as the concentration of tau and amyloid protein will be detected by SiMoA before and after treatment
Time frame: A total of 5 times will be measured, before the treatment, immediately after the treatment, 1-, 3- and 6-month follow-ups.
Magnetic Resonance Imaging
Brain function before and after treatment will be measured by MRI
Time frame: A total of 3 measurements, before treatment, immediately after treatment, 1 month follow-up
Incidence of side effects
After daily treatment, the subjects will be interviewed by the investigator, and the possible adverse reactions such as headache and fatigue ect. observed will be collected and recorded in the case report form. After the end of the experiment, investigators will calculate the probability of the occurrence of the side effects observed in the experiment through the case report form in the interview.
Time frame: Interviews will be conducted daily after treatment and once at 1-, 3- and 6-month follow-ups.
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