Effect of Neuronavigated Theta-Burst Transcranial Magnetic Stimulation (TBS) for Early Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 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
Comparison of the therapeutic effects of two neuronavigated theta-pulse transcranial magnetic stimulation in patients with Alzheimer's disease and their underlying neural mechanisms
详细描述
All patients underwent a series of medical assessments 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 1(real 1) and rTMS group 2 (real 2). In real group 1, the investigators constructed the core damage network of mild cognitive impairment by the method of damage network mapping and targeted to modulate this network in anticipation of improving the cognitive function of the patients. In real group 2, the investigators constructed the executive control network through previous literature reports and targeted to modulate this network in anticipation of improving patients' cognitive functions. 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 symptom assessments. Each patient would be treated for continuous 14 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, ADAS-cog, 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 underwent a magnetic resonance imaging (MRI) scan with multiple modalities.
After the last treatment, the MMSE, MoCA and ADAS-cog 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, magnetic resonance imaging scan in multi-modalities. Three 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
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 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 15 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 Magnetic Stimulation-Real 2
Participants will receive active real 2 TMS once daily for two weeks
干预措施: transcranial magnetic stimulation (Other)
Transcranial Magnetic Stimulation-Real 1
Participants will receive active real 1 TMS once daily for two weeks
干预措施: transcranial magnetic stimulation (Other)
结局指标
主要结局
Alzheimers Disease Assessment Scale Cognitive section(ADAS-Cog)
时间窗: baseline, 2 weeks and 12 weeks after 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 magnetic stimulation (TMS).The ADAS-COG scale tests orientation, language, structure, use of ideas, immediate recall of words and word re-recognition, and consists of 11 questions out of a possible 70 points, with the higher the score the more cognitively impaired.
Mini Mental State Examination(MMSE)
时间窗: baseline, 2 weeks and 12 weeks after treatment
The changes in MMSE will constitute the primary research outcome.The full name of MMSE is mini-mental state examination, and the scale consists of 30 subject, include the following seven aspects: time orientation, place orientation,immediate memory,attention and calculation,delay memory,language, visual space.One point is awarded for each question correctly answered during MMSE evaluation. If subject give the wrong answer or don't know answer he/she awarded 0 score, scope of scale score of 0 to 30 points. The higher the score, the better. In this study, changes in MMSE scores before and after treatment were used as primary observations,the investigators hoped that scores would increase after treatment.
次要结局
- Hooper visual organization test Hooper visual organization test(HVOT)(baseline, 2 weeks and 12 weeks after treatment)
- Trail Making Test(TMT )(baseline, 2 weeks and 12 weeks after treatment)
- Montreal Cognitive Assessment (MoCA)(baseline, 2 weeks and 12 weeks after treatment)
- Digital Span Test; Forward and Backward(DST)(baseline, 2 weeks and 12 weeks after treatment)
- Hamilton Depression Scale(HAMD )(baseline, 2 weeks and 12 weeks after treatment)
- Hamilton Anxiety Scale(HAMA)(baseline, 2 weeks and 12 weeks after treatment)
- Neuropsychiatric Inventory(NPI)(baseline, 2 weeks and 12 weeks after treatment)
- Geriatric depression scale(GDS)(baseline, 2 weeks and 12 weeks after treatment)
- The Stroop color test(baseline, 2 weeks and 12 weeks after treatment)
- Judgment of line Judgment of line orientation test orientation test(JLOT)(baseline, 2 weeks and 12 weeks after treatment)
- EEG power in the typical spectral bands(baseline, 2 weeks and 12 weeks after treatment)
- Logic Memory Test(LMT)(baseline, 2 weeks and 12 weeks after treatment)
研究者
WANG KAI
Director of medical psychological department, Anhui Medical University
Anhui Medical University