Evaluate the safety and efficacy of personalized network-guided transcranial magnetic stimulation for treating behavioral and psychological symptoms in patients with Alzheimer's disease.
1.Diagnosis of Alzheimer's disease according to the 2011 NIA-AA diagnostic criteria. 2.Mini-Mental State Examination (MMSE) score between 10 and 24; 3.Clinical Dementia Rating (CDR) score between 0.5 and 2; 4.Neuropsychiatric Inventory (NPI) score ≥4; 5.Education duration ≥5 years, or ability to complete the required cognitive and neuropsychological assessments; 6.Age ≥50 years and right-handedness; 7.Stable use of anti-dementia medications, including an NMDA receptor antagonist and/or cholinesterase inhibitors, for at least one month before rTMS intervention; 8.The patient and his or her family member or legal representative are able to understand the study procedures and provide written informed consent.
1. Recevied rTMS treatment in the past 3 months. 2. Depression or other psychiatric disorders. 3. History of head injury, stroke, epilepsy or other neurologic disease. 4. Organic brain defects on T1 or T2 images. 5. History of unexplained loss of consciousness. 6. Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, or any implanted medical device that is incompatible with MRI. 7. Family history of medication refractory epilepsy. 8. History of substance abuse within the last 6 months.
Parallel
transcranial magnetic stimulation
Other interventionNeuronavigated Theta-Burst Transcranial Magnetic Stimulation Other Name:
transcranial magnetic stimulation
Other interventionNeuronavigated Theta-Burst Transcranial Magnetic Stimulation Other Name:
Neuropsychiatric Inventory (NPI)
The Neuropsychology Scale (NPI) evaluates 12 neuropsychiatric disorders which included 10 neuropsychiatric symptoms and 2 autonomic neurological symptoms based on the caregiver's perception of the patient's behavior and the perceived distress. Each item was evaluated for its occurrence frequency (1-4 points) and severity (1-3 points). The frequency and severity were multiplied to obtain the score (0-12 points) of each item.The patient's assessment rating ranges from 0 to 144, and the caregiver's distress rating score is 0 to 60. The lower the score, the lighter the symptoms.
Alzheimers Disease Assessment Scale Cognitive section (ADAS-Cog)
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)
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 secondary outcome measure.
Montreal Cognitive Assessment (MoCA)
The changes in MoCA will be used to assess the response to TMS. MoCA was developed by Nasreddine et al. based on clinical experience and reference to the MMSE cognitive items and scores, and the final version was finalized in November 2004. The investigators adopted a localized version (Mandarin version#includes 2 alternative versions) in line with the Chinese cultural background. It includes 11 inspection items in 8 cognitive fields, including visual structure skills, executive function, naming, attention and calculation, language, abstract thinking, memory, and orientation. The normal score range from 26 to 30. Anyone who has been education for less than 12 years will need to add one point to his final score. The final score of the higher the better.
Digital Span Test; Forward and Backward (DST)
The changes in DST will constitute the secondary research outcome. Digital span test (DST) was commonly used to evaluate attention ability and instantaneous memory ability. There are two types of test: forward (0-14) and backward (0-13). In the forward test, the subjects were asked to retell the the digits immediately after hearing it untilthey could not be repeated correctly. In backward test, the subjects were asked to repeat a set of numbers in reverse order until they could not be repeated correctly. The length of the last set of Numbers correctly repeated by the subjects was the final score, forward and backward are counted separately. The higher the score, the better.
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