A retrospective analysis of ultrasound neuromodulation therapy using transcranial pulse stimulation in 58 dementia patients
Sonja Radjenovic, Lena Bender, Martin Gaal, Daria Grigoryeva, Michael Mitterwallner, Sarah Osou, Anna Zettl, Nina Plischek, Patrick Lachmair, Katrin Herzhauser, Eva Matt, Roland Beisteiner
Abstract
BACKGROUND: Novel ultrasound neuromodulation techniques allow therapeutic brain stimulation with unmet precision and non-invasive targeting of deep brain areas. Transcranial pulse stimulation (TPS), a multifrequency sonication technique, is approved for the clinical treatment of Alzheimer's disease (AD). Here, we present the largest real-world retrospective analysis of ultrasound neuromodulation therapy in dementia (AD, vascular, mixed) and mild cognitive impairment (MCI). METHODS: The consecutive sample involved 58 patients already receiving state-of-the-art treatment in an open-label, uncontrolled, retrospective study. TPS therapy typically comprises 10 sessions (range 8-12) with individualized MRI-based target areas defined according to brain pathology and individual pathophysiology. We compared the CERAD-Plus neuropsychological test battery results before and after treatment, with the CERAD Corrected Total Score ( CTS) as the primary outcome. Furthermore, we analyzed side effects reported by patients during the treatment period. RESULTS: = 19.44). The group of top-responders (top quartile) improved even by 9.8 points. Fewer than one-third of all patients reported any sensation during treatment. Fatigue and transient headaches were the most common, with no severe adverse events. CONCLUSIONS: The findings implicate TPS as a novel and safe add-on therapy for patients with dementia or MCI with the potential to further improve current state-of-the-art treatment results. Despite the individual benefits, further randomized, sham-controlled, longitudinal clinical trials are needed to differentiate the effects of verum and placebo.