Behavioral and Psychological Symptoms in Alzheimer's Disease, Individualized Navigation, Transcranial Magnetic Stimulation
Conditions
Keywords
behavioral and psychological symptoms in Alzheimer's disease, Transcranial Magnetic Stimulation, Individualized navigation
Brief summary
Evaluate the safety and efficacy of personalized network-guided transcranial magnetic stimulation for treating behavioral and psychological symptoms in patients with Alzheimer's disease.
Detailed description
All participants will undergo a series of medical evaluations before and after repetitive transcranial magnetic stimulation (rTMS), including physical examination and routine laboratory tests. After meeting the eligibility criteria and providing written informed consent, each participant will complete cognitive assessments and receive rTMS treatment at the First Affiliated Hospital of Anhui Medical University. Eligible participants will be randomly assigned to the real rTMS group or the sham rTMS group using a random-number table. The individualized stimulation target for each participant will be determined based on the participant's own magnetic resonance imaging data and a predefined BPSD network. Participants will then receive either real or sham rTMS treatment for two weeks. Sham stimulation will be delivered using a sham coil. Except for the stimulation coil, all experimental procedures will be identical between the two groups. Based on a statistical power of 0.80, an effect size of 0.98, a two-sided significance level of 0.05, and an anticipated dropout rate of 10%, the final sample size will be 20 participants per group. This is a double-blind study in which both participants and clinical raters will be blinded to group allocation. Only one researcher responsible for randomization will have access to the allocation list. Each participant will receive rTMS treatment for 14 days. Before treatment, a trained researcher will administer cognitive assessments and neuropsychological tests. The primary outcome will be the total score of the Neuropsychiatric Inventory (NPI). Secondary assessments will include measures of cognitive function, including the ADAS-Cog, MoCA, MMSE, DST, Stroop test, BNT-30, VFT, and CDT; memory function assessed by the CAVLT; emotional symptoms assessed by the HAMA and HAMD; and treatment tolerability. All assessments will be completed within two days. Participants will also undergo multimodal MRI and electroencephalography (EEG) examinations. After the final rTMS session, treatment-related adverse events will be assessed, and participants will be instructed to answer relevant questions based on their condition during the previous 14 days. Participants will also complete the same neuropsychological assessment battery as at baseline and undergo multimodal MRI and EEG examinations again.
Interventions
OTHERtranscranial magnetic stimulation
Neuronavigated Theta-Burst Transcranial Magnetic Stimulation Other Name:
Sponsors
Anhui Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuropsychiatric Inventory (NPI) | Baseline and 2 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alzheimers Disease Assessment Scale Cognitive section (ADAS-Cog) | Baseline and 2 weeks | 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) | Baseline and 2 weeks | 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) | Baseline and 2 weeks | 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) | Baseline and 2 weeks | 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. |
| Hamilton Depression Scale (HAMD) | Baseline and 2 weeks | Hamilton Depression Scale (HAMD) compiled by Hamilton in 1960, is the most common clinical to assess Depression Scale. In this study, we selected the HAMD version with 17 questions. Subjects were assessed for their depression in the past week. Each question scored between 0 and 4 points. Higher scores indicate more depressive symptoms. The severity of the disease and the therapeutic effect can be evaluated after treatment. |
| Hamilton Anxiety Scale (HAMA) | Baseline and 2 weeks | Hamilton Anxiety Scale (HAMA) was compiled by Hamilton in 1959. It was one of the most commonly used scales in psychiatric clinic, including 14 items. It is often used in clinical diagnosis and degree classification of anxiety disorder. The subjects were assessed for their anxiety in the past week. Each question scored between 0 and 4 points. The higher the score, the more symptoms of anxiety. |
| The Stroop color word test | Baseline and 2 weeks | The Stroop color word test was developed by Stroop in 1935 and is used to evaluate the attention function of the subject. The subject is required to correctly read the target color on the stimulus card and record the completion time. The final completion time is the score of the participant. The shorter the time used, the better the performance of the subjects. |
| TMT (Trail Making Test) | Baseline and 2 weeks | The Trail Making Test (TMT) is divided into two parts, part A and part B. Part A requires the subject to connect 25 Numbers on the paper in sequence, and part B requires the subject to connect 25 Numbers of different colors alternately in sequence. The time it takes for the subject to complete all the Numbers is the subject's final score. |
Countries
China
Contacts
CONTACTKai Wang
CONTACTXingqi Wu
Outcome results
None listed