A largely untested and unproven treatment for Alzheimer’s disease, called transcranial pulse stimulation (TPS), is becoming popular around the world, although experts are skeptical.
A largely untested and unproven treatment for Alzheimer’s disease called transcranial pulse stimulation (TPS) is becoming popular around the world, although experts are skeptical.
The non-invasive technique involves using high-frequency sound waves on the skull to stimulate brain regions. It also supposedly helps to regenerate cells and slow or halt the rapid deterioration of the brain.
Storz Medical, the Switzerland-based manufacturer of the device used, indicates at least 1,500 patients in 23 countries have received a total of about 10,000 treatment sessions. That’s actually a very low number, given that Alzheimer’s Disease International reports there are more than 55 million people living with dementia globally in 2020, with the number expected to hit 78 million in 2030 and 139 million in 2050.
Anecdotally, the therapy appears effective. STAT News described the treatment in an 80-year-old German patient. His family believes it has made a world of difference. Prior to receiving the treatment, Manfred Sköries, who has lived with Alzheimer’s, Parkinson’s and Lewy body dementia since 2012, was “silent, unresponsive and moved mostly in a wheelchair; now he sometimes walks up and down stairs, bursts into conversations and has regained a sense of humor.”
Experts indicate that the science behind the treatment, so far at least, is undeveloped and unproven. The treatment also costs thousands of dollars and is not covered by insurance.
Tim Beanland, Ph.D., head of knowledge management at the Alzheimer’s Society in the U.K., told STAT News, “It’s concerning that claims are being made which describe TPS as ‘clinically proven’ to reduce the symptoms of dementia. To our knowledge, there is no convincing evidence to justify this.”
A study published in Neurology and Therapy evaluated TPS in Alzheimer’s, analyzing changes in functional connectivity measured with functional MRI (fMRI). In this study, they found what they described as a “dichotomy of functional effects.”
That is, patients with Alzheimer’s had improved cognition and language, but their visuo-constructive functions got worse. Visuo-constructive functions were evaluated by the ability to reconstruct geometric shapes after being shown them. This study consisted of 18 patients with no control. All patients were clinically stable with probable Alzheimer’s and had been on at least three months of stable antidementia therapy.
It’s also worth comparing this treatment to the only new drug to have been approved by the U.S. Food and Drug Administration to treat Alzheimer’s in the past 19 years, Biogen’s Aduhelm (aducanumab). The drug was approved by the FDA in June 2021 and has been mired in controversy ever since. Aduhelm is an antibody designed to clear beta-amyloid plaques from the brains of Alzheimer’s patients, which it appears to do reasonably well.
Its clinical benefits and positive effect on memory and cognition are not as clear, although in clinical studies, the highest dose did appear to slow the progression of the disease. It also comes with a risk of amyloid-related imaging abnormalities (ARIA-E), also known as cerebral edema.
In April, the U.S. Center for Medicare and Medicaid Services (CMS) severely limited the availability of the drug, agreeing to only reimburse for it within the context of a clinical trial. Also in April, Biogen gave up on trying to get the drug approved in Europe and withdrew its Marketing Authorization Application (MAA).
Yet, arguably, Aduhelm has been evaluated in significantly more patients with better-documented success than TPS.
The primary research backing Storz’s claims was led by Dr. Roland Beisteiner, M.D., an associate professor of neurology at the Medical University of Vienna. Beisteiner ran experiments partially funded by Storz and sometimes with company researchers. In fact, a search through recently published articles on TPS commonly includes Beisteiner as one of the authors, whether in Alzheimer’s, clinical depression for younger patients or long-term effects on the human brain.
For example, Beisteiner published a study in 2019 with no control group saying that 35 Alzheimer’s patients demonstrated significant improvements in memory and speaking tests after only two to four weeks of TPS treatment and that the positive effects lasted at least three months. A follow-up of 17 of them suggested there was a decrease in degeneration in brain networks associated with Alzheimer’s. Another study published in February found that the same patients had decreased depression scores after two to four weeks of TPS.
None of the studies conducted to date assessing TPS are double-blind, randomized, controlled trials and none have evaluated long-term effects beyond three months. A well-designed, more conclusive study would use a placebo control, such as evaluating a real TPS device on some patients while using a test device on others.
The studies conducted also tested patients whose disease varied significantly in severity and nature, while also having comorbidities such as depression, panic disorder, coronary heart disease and suspected epilepsy.
