Abstract：
BACKGROUND: This study explores Transcranial Pulse Stimulation (TPS) as a potential non-invasive treatment for Alzheimer\'s disease (AD), focusing on its impact on cognitive functions and behavioral symptoms.
METHODS: In a prospective, one-arm open-label trial, ten patients with mild to moderate dementia due to AD were assessed using the Alzheimer\'s Disease Assessment Scale (ADAS-Cog), Neuropsychiatric Inventory (NPI), Pfeffer Functional Activities Questionnaire, and Zarit Caregiver Burden Interview. Assessments occurred at 30- and 90-days post-treatment. The TPS protocol consisted of 10 sessions over five weeks, using the Neurolith® device to deliver 6000 focused shockwave pulses at 0.25 mJ/mm2 and a frequency of 4 Hz.
RESULTS: TPS significantly reduced neuropsychiatric symptoms, with NPI scores decreasing by 23.9 points (95% CI: -39.19 to -8.61, p = 0.0042) after 30 days, and by 18.9 points (95% CI: -33.49 to -2.91, p = 0.022) after 90 days. These changes had large effect sizes (Cohen\'s dz = 1.43 and dz = 0.94, respectively). A decreasing trend was observed in the ADAS-Cog score (-3.6, 95% CI: -7.18 to 0.00, p = 0.05) after 90 days, indicating a potential reduction in cognitive impairment, though not statistically significant.
CONCLUSIONS: The preliminary results indicate that TPS treatment leads to significant improvement in neuropsychiatric symptoms in AD patients, showing promise as a therapeutic approach for AD. Further research is needed to fully establish its effectiveness, especially concerning cognitive functions.
METHODS: In a prospective, one-arm open-label trial, ten patients with mild to moderate dementia due to AD were assessed using the Alzheimer\'s Disease Assessment Scale (ADAS-Cog), Neuropsychiatric Inventory (NPI), Pfeffer Functional Activities Questionnaire, and Zarit Caregiver Burden Interview. Assessments occurred at 30- and 90-days post-treatment. The TPS protocol consisted of 10 sessions over five weeks, using the Neurolith® device to deliver 6000 focused shockwave pulses at 0.25 mJ/mm2 and a frequency of 4 Hz.
RESULTS: TPS significantly reduced neuropsychiatric symptoms, with NPI scores decreasing by 23.9 points (95% CI: -39.19 to -8.61, p = 0.0042) after 30 days, and by 18.9 points (95% CI: -33.49 to -2.91, p = 0.022) after 90 days. These changes had large effect sizes (Cohen\'s dz = 1.43 and dz = 0.94, respectively). A decreasing trend was observed in the ADAS-Cog score (-3.6, 95% CI: -7.18 to 0.00, p = 0.05) after 90 days, indicating a potential reduction in cognitive impairment, though not statistically significant.
CONCLUSIONS: The preliminary results indicate that TPS treatment leads to significant improvement in neuropsychiatric symptoms in AD patients, showing promise as a therapeutic approach for AD. Further research is needed to fully establish its effectiveness, especially concerning cognitive functions.
摘要：
背景：这项研究探索了经颅脉冲刺激（TPS）作为阿尔茨海默病（AD）的潜在非侵入性治疗方法，关注其对认知功能和行为症状的影响。
方法：在前瞻性中，单臂开放标签试验，使用阿尔茨海默病评估量表（ADAS-Cog）评估了10例因AD引起的轻度至中度痴呆的患者，神经精神量表（NPI），Pfeffer功能活动问卷，和Zarit照顾者负担访谈。评估发生在治疗后30天和90天。TPS协议包括五周的10次会议，使用Neurolith®设备以0.25mJ/mm2和4Hz的频率提供6000个聚焦冲击波脉冲。
结果：TPS显著减轻神经精神症状，30天后，NPI评分下降23.9分（95%CI：-39.19至-8.61，p=0.0042），90天后下降18.9分（95%CI：-33.49至-2.91，p=0.022）。这些变化具有大的效应大小(分别为Cohen的dz=1.43和dz=0.94)。90天后ADAS-Cog评分呈下降趋势(-3.6,95%CI:-7.18至0.00,p=0.05),表明认知障碍的潜在减少，虽然没有统计学意义。
结论：初步结果表明，TPS治疗可显著改善AD患者的神经精神症状，显示出作为AD治疗方法的希望。需要进一步研究以充分确立其有效性,尤其是关于认知功能。
方法：在前瞻性中，单臂开放标签试验，使用阿尔茨海默病评估量表（ADAS-Cog）评估了10例因AD引起的轻度至中度痴呆的患者，神经精神量表（NPI），Pfeffer功能活动问卷，和Zarit照顾者负担访谈。评估发生在治疗后30天和90天。TPS协议包括五周的10次会议，使用Neurolith®设备以0.25mJ/mm2和4Hz的频率提供6000个聚焦冲击波脉冲。
结果：TPS显著减轻神经精神症状，30天后，NPI评分下降23.9分（95%CI：-39.19至-8.61，p=0.0042），90天后下降18.9分（95%CI：-33.49至-2.91，p=0.022）。这些变化具有大的效应大小(分别为Cohen的dz=1.43和dz=0.94)。90天后ADAS-Cog评分呈下降趋势(-3.6,95%CI:-7.18至0.00,p=0.05),表明认知障碍的潜在减少，虽然没有统计学意义。
结论：初步结果表明，TPS治疗可显著改善AD患者的神经精神症状，显示出作为AD治疗方法的希望。需要进一步研究以充分确立其有效性,尤其是关于认知功能。
