P 42 Pilot clinical and EEG-biomarker results of transcranial pulse stimulation in Alzheimer's disease

Abstract

Introduction: Transcranial Pulse Stimulation (TPS) is a new non-invasive neuromodulation therapy that uses shockwaves for the treatment of Alzheimeŕs Disease (AD). In humans, there is first evidence for beneficial clinical effects after a series of six TPS sessions. Long-term results and controlled trials are not yet reported. Experience from other centers is lacking. We report on first clinical experience from a center in Germany with additional longitudinal EEG recordings. Patients and Methods: A consecutive number of ten TPS-treated AD-patients was examined. Patients received 4-12 sessions of 3000-6000 pulses per session with 4 Hz of 0.2 mJ/mm2 (MRI navigated bifrontal biparietal, bitemporal and praecuneus) using the Neurolith System (Storz Medical). Session were planned for six initial sessions over two weeks with a booster session every four weeks. Up to now, data is available for 1-24 weeks of treatment period. Numerous cognitive and affective scores were assessed (e.g. ADAS, MMST, MoCa, BDI). For exploratory reasons a heterogeneous group with MMST range from 2 to 27 was included. EEG recordings were done before and after the first sessions and after the complete cycle of six sessions. Results: Treatment was very well tolerable with a low number of side effects. One patient reported transient headache, two patient transient diffuse symptoms of nausea und a restless feeling. All patients improved at least transiently in one neuropsychological test. Caregivers confirmed improvement of activity of daily living in most of the patients. Significant mean improvement was best detected in the ADAS sum score with 18%. Some patients only showed minor improvements, but best improvement in a patient was 40%. Marked improvement of mood was seen in some patients. EEG showed increase of power across all frequency bands after the first session (n.s.); more consistent changes of EEG entropy were noticed. Conclusion: These pilot results confirm the recently published results from Austria with respect to low side effects and extent of cognitive improvement. The sample was heterogeneous but some patients showed a marked improvement of mood and cognition. Thus, more data and subgroups need to be analyzed. Prospective controlled trials would be the next step to proof the efficacy of this new technique. EEG entropy might be a promising tool as a biomarker for treatment response.