Investigating the Effect of Theta-Burst Transcranial Magnetic Stimulation (TBS) add-on Treatment for Early Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Associative Memory
研究概览
简要总结
To investigate the treatment effect of theta-burst transcranial magnetic stimulation on Alzheimer patients, and the underlying neural mechanism by MRI.
详细描述
All patients underwent a medical evaluation that included physical examination and routine laboratory studies before and after repetitive transcranial magnetic stimulation (rTMS) treatment. Upon meeting the inclusion criteria and providing informed consent, each participant will complete a series of cognitive assessments and rTMS treatments at the First Affiliated Hospital of AnHui medical university. Patients were randomly allocated to rTMS 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, clinical raters, and all personnel responsible for the clinical care of the patient remained masked to allocated condition and allocation parameters. Only rTMS administrators had access to the randomization list; they had minimal contact with the patients, and no role in cognitive and synptom assessments. Each patient would be treated for continuous 15 days by rTMS.
Before the rTMS 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 associative memory 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 patients had receiving a magnetic resonance imaging scan in multi-modalities.
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 15 days. The patients had also receiving a battery measure of neuropsychological tests, magnetic resonance imaging scan in multi-modalities. Two month 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
- Treatment
- 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 NINCDS-ACDRADA criteria.
- •Subjects must have a MMSE score between 10 and 27,indicating mild cognitive impairment or dementia
- •CDR score ≤ 2
- •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 Magnetic Stimulation-Real
Participants will receive active TMS once daily for two weeks
干预措施: transcranial magnetic stimulation (Other)
Transcranial Magnetic Stimulation-Sham
Participants will receive sham TMS once daily for two weeks
干预措施: transcranial magnetic stimulation (Other)
结局指标
主要结局
Associative Memory
时间窗: baseline, 2 weeks and 8 weeks after treatment
The changes in Associative Memory will constitute the major research outcome measure used to assess response to rTMS.
次要结局
- GDS(Geriatric depression scale)(baseline, 2 weeks and 8 weeks after treatment)
- LMT (Logic Memory Test)(baseline, 2 weeks and 8 weeks after treatment)
- DST (Digital Span Test; Forward and Backward)(baseline, 2 weeks and 8 weeks after treatment)
- TMT (Trail Making Test)(baseline, 2 weeks and 8 weeks after treatment)
- HAMD (Hamilton Depression Scale)(baseline, 2 weeks and 8 weeks after treatment)
- HAMA (Hamilton Anxiety Scale)(baseline, 2 weeks and 8 weeks after treatment)
- NPI (Neuropsychiatric Inventory)(baseline, 4 weeks after treatment)
- MRI measures(baseline, 2 weeks after treatment)
- 2-BACK(special-version)(baseline, 2 weeks and 8 weeks after treatment)
- changes in Montreal Cognitive Assessment (MoCA)(baseline, 2 weeks and 8 weeks after treatment)
- The changes in MMSE(Mini Mental State Examination)(baseline, 2 weeks and 8 weeks after treatment)
- JLOT(Judgment of line Judgment of line orientation test orientation test)(baseline, 2 weeks and 8 weeks after treatment)
- HVOT(Hooper visual organization test Hooper visual organization test)(baseline, 2 weeks and 8 weeks after treatment)
- The Stroop color test(baseline, 2 weeks and 8 weeks after treatment)
研究者
WANG KAI
Director of medical psychological department, Anhui Medical University
Anhui Medical University