Effect of Transcranial Alternating Current Stimulation(tACS) for Early Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Alzheimers Disease Assessment Scale Cognitive section(ADAS-Cog)
研究概览
简要总结
To investigate the clinical effect neural mechanism of transcranial alternating current stimulation in early Alzheimer's disease
详细描述
Upon meeting the inclusion criteria and providing informed consent, each participant will complete a series of cognitive assessments and tACS at the First Affiliated Hospital of Anhui medical university. Patients were randomly allocated to tACS group and the sham group. There are about 20 patients in each group. For the all patients, allocation was by coin toss. Patients were studied using a double-blind design. Study participants and all personnel responsible for the clinical care of the patient remained masked to allocated condition and allocation parameters. Only tACS administrators had access to the randomization list; they had minimal contact with the patients, and no role in cognitive and symptom assessments. Each patient would be treated for continuous 14 days by tACS.
Before the tACS treatment, a series of cognitive assessments and neuropsychological tests were obtained by a trained investigator to assess baseline. Each assessment will involve a set of assessment tools, the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) as the primary outcome measure and various other tasks and questionnaires to measure cognition (including MoCA,MMSE, DS, Stroop test, TMT, BNT-30, VFT, CDT,JLOT. Form H,HVOT), memory (CAVLT, LMT), emotion(HAMA-17,HAMD-14,GDS-30), behavioral and psychological symptoms(NPI), and treatment tolerability. All the tests are conducted in two days. The patient received resting EEG data collection. After the last treatment, the MoCA, and associative memory were obtained, as well as the Global Index of Safety to assess adverse events of the treatment. Patients were instructed to focus their answers on the past 14 days. The patients had also receiving a battery measure of neuropsychological tests, resting EEG. Two months after the last treatment, participants were interviewed to obtain the same assessment as before. They were instructed to focus their answers on the past months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject diagnosed with early Alzheimer's disease or related diseases according to NIA-AA criteria.
- •Subjects must have a MMSE score between 10 and 27,indicating mild cognitive impairment or dementia.
- •CDR score ≤
- •Subject under treatment by IAChE for at least 3 months.
- •psychotropic treatments are tolerated if they were administered and unchanged for at least 3 months.
排除标准
- •Any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder).
- •History of head injury,stroke,or other neurologic disease.
- •Organic brain defects on T1 or T2 images.
- •History of seizures or unexplained loss of consciousness.
- •Implanted pacemaker,medication pump,vagal stimulator,deep brain stimulator.
- •Family history of medication refractory epilepsy.
- •History of substance abuse within the last 6 months.
研究组 & 干预措施
transcranial alternating current stimulation-Sham
Participants will receive sham tACS once daily for 14 days
干预措施: Sham transcranial alternating current stimulation (Device)
transcranial alternating current stimulation-Real
Participants will receive real tACS once daily for 14 days
干预措施: Transcranial alternating current stimulation (Device)
结局指标
主要结局
Alzheimers Disease Assessment Scale Cognitive section(ADAS-Cog)
时间窗: changes from baseline at 14 days and 12 weeks post-treatment
The changes in Alzheimers Disease Assessment Scale Cognitive section (ADAS-Cog) will constitute the major research outcome measure used to assess response to transcranial alternating current stimulation (tACS).The ADAS-Cog scale is a scale used for clinical assessment of dementia patients with some memory efficiency tests, which can be used as an objective assessment of memory. The scale is considered a tool capable of providing a specific assessment of the severity of cognitive and non-cognitive behavioral impairments in people with Alzheimer's disease or dementia. The advantage of the ADAS-Cog compared to other scales used in the same clinical area is that its score quantifies clinical and impressionistic aspects of the patient assessed by the examiner, as well as objectively defined cognitive characteristics. The higher the ADAS-Cog score, the worse the cognitive function. The minimum value is 0 and the maximum is 86.
次要结局
- electroencephalography(changes from baseline at 14 days and 12 weeks post-treatment)
- LMT (Logic Memory Test)(changes from baseline at 14 days and 12 weeks post-treatment)
- HAMD (Hamilton Depression Scale)(changes from baseline at 14 days and 12 weeks post-treatment)
- MMSE(Mini Mental State Examination)(changes from baseline at 14 days and 12 weeks post-treatment)
- HAMA (Hamilton Anxiety Scale)(changes from baseline at 14 days and 12 weeks post-treatment)
- JLOT(Judgment of line Judgment of line orientation test orientation test)(changes from baseline at 14 days and 12 weeks post-treatment)
- Associative Memory(changes from baseline at 14 days and 12 weeks post-treatment)
- changes in Montreal Cognitive Assessment (MoCA)(changes from baseline at 14 days and 12 weeks post-treatment)
- GDS(Geriatric depression scale)(changes from baseline at 14 days and 12 weeks post-treatment)
- HVOT(Hooper visual organization test Hooper visual organization test)(changes from baseline at 14 days and 12 weeks post-treatment)
- The Stroop color test(changes from baseline at 14 days and 12 weeks post-treatment)
- DST (Digital Span Test; Forward and Backward)(changes from baseline at 14 days and 12 weeks post-treatment)
- TMT (Trail Making Test)(changes from baseline at 14 days and 12 weeks post-treatment)
- NPI (Neuropsychiatric Inventory)(changes from baseline at 14 days and 12 weeks post-treatment)
研究者
WANG KAI
Director of medical psychological department, Anhui Medical University
Anhui Medical University