Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Placebo Comparator | Subjects sit comfortably in a recliner and receive FDA-approved transcranial alternating current stimulation (sham stimulation) with trained operators following standardized instructions. Subjects are advised to relax, drink water, and even sleep, and not communicate with the operator as much as possible. |
|
| treatment group | Experimental | Subjects sit comfortably in a recliner and receive FDA-approved transcranial alternating current stimulation (real stimulation) with trained operators following standardized instructions. Subjects are advised to relax, drink water, and even sleep, and not communicate with the operator as much as possible. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial alternating current stimulation(real stimulation) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | A total of 5 times will be measured, before the treatment, immediately after the treatment, 1-, 3- and 6-month follow-ups. |
| Measure | Description | Time Frame |
|---|---|---|
| Near-infrared spectroscopy | The brain function of the patients before and after treatment will be assessed by near infrared functional brain imaging | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiong Shi, doctor | Contact | 0551-62284377 | jshi2022@ustc.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jiong Shi, doctor | The First Affiliated Hospital of University of Science and Technology of China | Study Chair |
Not provided
After the research is published in an academic journal, a link to the laboratory website will be provided in the article so that others can view supplementary materials, etc. Access to the data requires the consent of the principal investigator and the ethics committee.
After the research is published in an academic journal, a link to the laboratory website will be provided in the article.
Access to the data requires the consent of the principal investigator and the ethics committee.
Not provided
Not provided
Investigators designed a randomized double-blinded placebo-controlled trial by randomly dividing subjects into two groups: one is the treatment group and the other is the placebo group.
Not provided
Not provided
Investigators designed a double-blinded trial in which neither the investigator nor the subjects know whether they will be received the treatment or a placebo.
|
| Transcranial alternating current stimulation(sham stimulation) | Device | 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. |
|
Event related potential indicators will be evaluated before and after treatment by electroencephalogram. |
| 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 | 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 | 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. | Interviews will be conducted daily after treatment and once at 1-, 3- and 6-month follow-ups. |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
Not provided
Not provided