Clinical research on Transcranial Pulse Stimulation (TPS) at the University of São Paulo

First of several studies on TPS in Alzheimer’s dementia published from South America

Transcranial Pulse Stimulation (TPS) has already established itself worldwide in 42 countries as a promising method against Alzheimer’s dementia. In view of the increasing global incidence of the disease – a challenge that Brazil is also facing – the University of São Paulo’s Institute of Rehabilitation Medicine (IMREA) is devoting intensive research to TPS. Their most recent publication, published on March 19, 2024 in “Brainstimulation”, is the precursor to a comprehensive placebo-controlled study on TPS and marks a further step in the clinical proof of concept for the effect of TPS shock wave therapy in Alzheimer’s dementia.

Effects of TPS on cognitive function and behavioral symptoms in Alzheimer’s patients

The aim of the first study, led by Dr. Gilson Tanaka Shinzato, was to investigate the effect of TPS shock waves on cognitive function and behavioral symptoms in Alzheimer’s patients with mild to moderate dementia.

Ten patients with mild to moderate Alzheimer’s disease were included in this prospective, open study. They were assessed using the Alzheimer’s Disease Assessment Scale (ADAS-Cog), the Neuropsychiatric Inventory (NPI), the Pfeffer Functional Activities Questionnaire and the Zarit Caregiver Burden Interview, 30 and 90 days after completion of treatment. As part of the TPS protocol, participants received 10 sessions over five weeks, during each of which the NEUROLITH TPS shockwave device delivered 6000 focused shockwave pulses with an energy of 0.25 mJ/mm²and a frequency of 4 Hz.

TPS treatment shows significant positive effects on neuropsychiatric symptoms

The study results show a significant positive effect of TPS treatment on neuropsychiatric symptoms in Alzheimer’s patients. The NPI scores, which measure the intensity of 12 neuropsychiatric symptoms, including delusions, hallucinations, agitation and depression, showed a significant improvement. An average reduction in NPI scores of 23.9 points was recorded 30 days after treatment (95% confidence interval: -39.19 to -8.61, p = 0.0042), while a reduction of 18.9 points was observed after 90 days (95% confidence interval: -33.49 to -2.91, p = 0.022). These results, with effect sizes of Cohen’s dz = 1.43 after 30 days and dz = 0.94 after 90 days, demonstrate a clinically significant reduction in the severity and frequency of neuropsychiatric symptoms in the Alzheimer’s dementia patients studied.

First study follows placebo-controlled study with higher number of subjects

Despite the limitations of the open study design and a still small number of subjects, the first published study by the University of São Paulo represents an important advance in research into TPS as a treatment approach for Alzheimer’s disease (AD), according to the authors. Particularly noteworthy are the improvements observed in neuropsychiatric symptoms, a crucial area in the management of Alzheimer’s disease. The trend towards improvement in cognitive function underlines the potential of TPS as a promising treatment option for Alzheimer’s dementia.

The Brazilians also see Transcranial Pulse Stimulation (TPS) as an important approach in the treatment of Alzheimer’s disease, especially with regard to the reduction of neuropsychiatric symptoms. The cognitive improvements, as evidenced by the positive development of ADAS-Cog scores, open up new perspectives in AD research and bring hope for a disease whose treatment options have so far been limited, the authors write. They argue for the need to conduct larger randomized controlled trials to confirm the preliminary results and evaluate the long-term efficacy and safety of TPS in Alzheimer’s treatment.

A randomized, double-blind and placebo-controlled study entitled “Non-invasive Brain Stimulation by Transcranial Pulse Stimulation as a Coadjunctive Treatment in Alzheimer’s Disease” (ClinicalTrials.gov ID: NCT05762926), also funded by the General Hospital of the University of São Paulo, is being led by Dr. Gilson Tanaka Shinzato and Prof. Dr. Linamara Rizzo Battistella. They are working together with Prof. Orestes Forlenza, a renowned Alzheimer’s researcher from the Institute of Psychiatry at the University of São Paulo – see also: https://alzheimer-science.com/en/news/interviews/current-studies-on-tps-university-sao-paulo)

“We give Transcranial Pulse Stimulation a very high priority in therapy and rehabilitation, also in the context of multimodal treatment options. TPS should be available to patients in the best possible way, as it also precisely reaches deep areas of the brain and only a few treatments are required to significantly improve the patient’s condition,” summarizes Dr. Shinzato.

Link to the study:

https://www.brainstimjrnl.com/article/S1935-861X(24)00043-3/fulltext