Transcranial Pulse Stimulation (TPS) 2023: Current status and future prospects of brain stimulation procedures

Numerous studies and scientific papers on TPS published in 2023

The year 2023 has seen a lot of movement in the research and public perception of non-invasive brain stimulation techniques (NIBS). The increasing prevalence of neurodegenerative and neurophysiological diseases such as Alzheimer’s dementia, other forms of dementia, Parkinson’s, but also depression and fatigue and, of course, long Covid and post-Covid make targeted research and therapy developments more urgent than ever. In addition to the successes in the development of new drugs for the treatment of early Alzheimer’s disease, which certainly show a step in the right direction, it is above all the so-called NIBS that are gaining increasing interest and recognition.

The various neurostimulation methods are being discussed in neurology and psychiatry as relevant and sensible therapy options and are being used more and more frequently. Supported by expansive scientific research, they offer new possibilities in therapy and, according to experts and institutions, are able to supplement current treatment methods and thus significantly relieve the burden on healthcare systems, which are now reaching their limits.

This year, deep brain stimulation (DBS) was the first neurostimulation procedure ever to be included in the new DGN guidelines, as it has been shown to be effective against motor symptoms in Parkinson’s disease for up to 11 years. However, DBS is a neurosurgical method in which electrodes have to be implanted directly in the brain in order to stimulate specific areas. It is therefore not a non-invasive brain stimulation procedure (NIBS), but can nevertheless be seen as a pioneer of a new era in medicine that uses physical principles to effectively treat numerous diseases.

Transcranial Pulse Stimulation (TPS): Outpatient procedure increasingly in the focus of science

In addition to deep magnetic stimulation (TMS), transcranial direct current stimulation (tDCS) and focused ultrasound stimulation (FUS), which are also receiving increased attention after decades of research, it is above all Transcranial Pulse Stimulation (TPS) that has taken some clear steps towards evidence in 2023, as Prof. Lars Wojtecki, Hospital zum Heiligen Geist Kempen, Heinrich Heine University Düsseldorf (HHU), at a scientific expert meeting attended by scientists from 14 countries in November 2023.

The neuromodulation procedure, which has been researched since the early 1990s and is carried out using the NEUROLITH shockwave system, which was approved in August 2018, has spread internationally over the past three years. This is primarily due to the fact that Transcranial Pulse Stimulation (TPS) offers particular advantages for both patients and the professionals using it: The shockwave procedure is performed on an outpatient basis, whereby the low-energy short shockwave pulses can penetrate the areas of the brain to be treated far more deeply and accurately than other NIBS methods thanks to special technology.

In addition, TPS only requires short, individual treatments of around 30 minutes each, which patients – around 10,000 patients have been treated so far – tolerate well and do not interfere with their everyday lives.

As a result, interest in TPS has grown significantly and over 20 universities and clinics worldwide are currently conducting research into the therapy in various areas.

This applies not only to the safety and therapeutic benefits of Alzheimer’s dementia, the central indication for Transcranial Pulse Stimulation (TPS), which have long been considered proven. According to the postulated modes of action (mechanotransduction and thus the increase in cell permeability to promote the permeability of cell membranes, release of neurotransmitters such as VEGF, increase in the messenger substances serotonin and dopamine, release of nitric oxide and production, differentiation and migration of stem cells and correlation of low BDNF concentrations in the brain, opening of the blood-brain barrier, to name just a few factors), researchers have also long been looking at indications such as Parkinson’s disease, other forms of dementia, fatigue, post-Covid syndromes, depression, autism and ADHD. Here, too, Transcranial Pulse Stimulation (TPS) is showing the first remarkable and promising effects in scientific studies.

In 2023, six new studies, mostly randomized, double-blind and sham-controlled, and fifteen additional publications and posters were presented in Transcranial Pulse Stimulation research.

Researchers agree: further extensive studies are needed quickly for the benefit of those affected

Transcranial Pulse Stimulation (TPS) has shown in clinical studies and practical applications that it can slow down the progression of Alzheimer’s dementia. There is also evidence of improvements in executive functions and a reduction in depressive states in patients.

It has also been shown that these positive effects are maintained in long-term observations over 12 months in patients who receive regular refresher treatments (usually a 30-minute treatment every six weeks). Importantly, the few reported side effects such as mild headaches, fatigue or dizziness for a maximum of 1-2 days after treatment are mild and only affect around four percent of patients, without the need for drug interventions.

Critics are still cautious about Transcranial Pulse Stimulation (TPS), but are nevertheless interested: The approach is hopeful and TPS could offer new possibilities for therapy, but studies with a larger number of test subjects and in relation to placebo are still lacking. The researchers already working on TPS agree with this, and will be joined by other university hospitals and institutions from 2024. They are working closely together, including on a multicenter basis, and various large studies are being planned or are already underway.

Upcoming paradigm shift: brain stimulation methods important element of modern therapy

The scientific community is also generally in agreement that the use of brain stimulation methods represents a great opportunity or necessity for tackling neurological and psychiatric illnesses in the context of society as a whole. For example, the German Society for Clinical Neurophysiology and Functional Imaging (DGKN) stated in a press release dated February 28, 2023 that “these promising approaches () could improve the care of patients in the future.”

The Center for Responsible Research and Innovation (CeRRi) at the Fraunhofer Institute for Industrial Engineering (IAO) goes one step further: In a white paper, they presented “a shared vision of the use of NIBS as a desirable future in the EU” and drew attention to the fact that technical therapy solutions are of “crucial importance for a healthier future for the population in Europe” (see also: Non-Invasive Brain Stimulation procedures: Increasingly Essential for Healthcare ).

Still not heard enough: voices of patients, relatives and practising doctors

Non-invasive brain stimulation techniques (NIBS) are still rarely mentioned in the media or in the general public, as the Fraunhofer Institute also criticizes in its white paper. While the discussion about the benefits, costs and side effects of the new antibody preparations lecanemab and donanemab is certainly taking place in the media and sometimes makes quite full-bodied promises to those affected, NIBS have rarely been mentioned to date.

Nevertheless, on World Alzheimer’s Day 2023, Prof. Ullrich Wüllner, Director of the Clinic for Neurodegenerative Diseases, Neurocenter of the University Hospital Bonn (UBK), was interviewed by the editors of the news program “RTL Aktuell” about Transcranial Pulse Stimulation (TPS). The renowned researcher: “We actually observe a stable course in two thirds of our patients. This means that mental performance, as measured by neurological tests, does not deteriorate!” (see: RTL Aktuell: Transcranial Pulse Stimulation (TPS) as a hopeful therapy option ). He told Alzheimer Science: “I hope that we will soon be able to further prove TPS in larger studies, including on Parkinson’s disease.”

Enthusiasm and gratitude are shown by numerous patients and their relatives: like the relative of a patient quoted in the program with Prof. Wüllner, “It’s like a miracle”, patients and relatives are often amazed at how treatment with TPS improves their quality of life, in some cases massively – and this has also been sustained over several years of observation. Doctors working with TPS report the same from their day-to-day practice: the therapy, which ultimately has no side effects, gives their patients significant improvements in memory performance and executive functions, relieves depression, anxiety and social withdrawal and literally leads to a new life worth living.

However, those affected and doctors working with TPS also agree that pioneering treatments such as TPS are difficult to find out about. Only attentive research and personal initiative lead those affected to clinics and practices; the level of awareness is still far too low.

But the signs are green: NIBS such as Transcranial Pulse Stimulation (TPS) are increasingly developing into relevant and helpful treatment aspects in modern therapy concepts in neurology and psychiatry – this applies not only to Europe, but also to other continents including the USA, where TPS has already been approved for clinical trials by the FDA.