Jonathan Moens, Stat News, June 1, 2022
BERLIN — Looking more like a barber than a doctor, orthopedic surgeon Musa Citak squirted gel on his patient’s head and massaged the gooey substance into his scalp as though it were shampoo. He then pulled out a handheld device and began sliding it across the side of the elderly man’s head.
“This is shockwave therapy,” Citak explained. As he moved the device, it made rapid clicking sounds, each click a high-frequency sound wave intended to stimulate brain regions and, according to Citak, help regenerate cells and halt the rapid deterioration of the patient’s brain.
Manfred Sköries, 80, has been living with a mixed diagnosis of Alzheimer’s disease, Parkinson’s, and Lewy body dementia since 2012, leaving him with significant memory loss, difficulty walking, and slurred speech. After trying several drug treatments and showing no significant improvements, his family reached out to Citak’s clinic in Berlin, TPS Nord. The clinic’s website promised “a causal treatment of symptoms” and “permanent stopping” of Alzheimer’s disease.
With no cure for Alzheimer’s, Sköries is one of hundreds of patients who have come to Citak in the past year, desperate for help. The treatment, known as “transcranial pulse stimulation,” is largely unproven, but it has exploded far beyond German borders: In just two years, around 85 clinics across Europe, Asia, the Middle East, and the United States have begun offering the therapy. Storz Medical, the Swiss-based manufacturer of the device, said at least 1,500 patients in 23 countries have undergone a total of about 10,000 treatment sessions.
Twenty minutes and 6,000 pulses later, Sköries’ therapy was complete. He looked exhausted, but his family was thrilled. This was his ninth session and his family said they have witnessed stunning results: Before the treatment, Sköries 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, they said.
“We are really convinced by the results,” said Maik Sköries, Manfred’s grandchild. “For us, this is the real deal.”
Yet anecdotes aren’t sound evidence, and the science behind TPS is far from convincing, experts say. Studies of its efficacy are limited and their methods questionable, and there’s no real understanding of how the technology acts on the brain beyond speculative theories, experts say. The treatment is also largely unregulated and expensive, costing thousands of dollars that patients have to pay out of pocket. Critics accuse clinicians adopting the technology and Storz Medical of taking advantage of families desperate for help.
“They’re raising false hopes,” said Robert Howard, professor of old age psychiatry at University College London. “I hesitate to use the word quackery, but this is not scientific evidence-based medicine.”
Major Alzheimer’s organizations are also skeptical. “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,” said Tim Beanland, head of knowledge management at the Alzheimer’s Society, a leading dementia charity based in the United Kingdom.
In a pilot study with no control group, Beisteiner reported in 2019 that after two to four weeks of TPS treatment, 35 Alzheimer’s disease patients showed significant improvements on a test of memory and speaking abilities. The effects lasted at least three months. A follow-up study analyzing 17 of these patients’ brain scans showed that these improvements were associated with a reduction in degeneration in brain networks implicated in Alzheimer’s disease. And in a paper published this past February, the team found that these same patients’ depression scores dipped after two to four weeks of TPS treatment.
But critics say the science is still premature. Only a handful of studies have looked at the effects of transcranial pulse stimulation specifically on Alzheimer’s patients. None was a double-blind randomized controlled trial — the gold-standard scientific method used to evaluate whether a treatment is effective — nor did any look at its long-term effects beyond three months.
Typically, such studies would control for the placebo effect by, for example, probing some patients with a real device and another group with a fake or “sham” device that mimics the sound and feel of TPS. But the studies so far have not done this in clinical trials, said Peter Whitehouse, professor of neurology at the University of Toronto.
The studies also reuse a small group of Alzheimer’s patients that vary wildly in the severity and nature of their conditions, making it hard to discern the true benefits of the treatment. Many patients in the 2019 study, for instance, had comorbidities like depression, panic disorder, coronary heart disease, and suspected epilepsy.
“This technology may turn out to be very effective. It may turn out to be terrific,” said Michael Gusmano, a professor of health policy at Lehigh University in Pennsylvania and author of a book on medical devices. “But at this stage, I don’t think we have adequate evidence.”
The lack of stringent regulations on medical devices has led to major scandals in Europe. In one case, TÜV Rheinland, the notified body in Germany that granted CE marking to Neurolith, certified faulty breast implants filled with cheap, industrial-grade silicone that affected 400,000 women, many of whom suffered from infections and had to have the implants removed.
Even if the risks of physical harm turn out to be negligible, experts say patients face other kinds of harm. The full treatment generally costs between $3,000 and $6,000, depending on the clinic, and there is currently no health insurance — public or private — that covers these costs, said Manfred Schulz, director of business development and neurology at Storz Medical. Storz Medical is negotiating with German insurance companies to try and convince them to cover the treatment. Patients pay hundreds of dollars more for additional “booster” sessions if they are deemed necessary.
The operator of a Florida clinic offering TPS uses a similarly broad approach to using the technology. Boris Kawliche, a psychiatrist who has been offering TPS at Brandon TMS and Psychiatry since November, said he is the only clinician in the U.S. to own a Neurolith and has treated about 10 patients with various conditions, including Alzheimer’s, traumatic brain injury, aphasia, depression, and Parkinson’s. All patients were treated in exactly the same way, despite significant differences in the underlying causes of their illnesses and their symptoms.
His results, which haven’t been published or peer-reviewed, have been mixed, he said: Some patients show virtually no sign of change. Others, like a Parkinson’s patient in his mid-70s, showed remarkable, though temporary, improvements; before treatment he was withdrawn and unable to walk. After a couple of sessions, he was greeting people and walking long distances, the doctor claimed.
“Unfortunately, he got home and the effects lasted only two weeks,” Kawliche told STAT.
Neurolith is not approved by the U.S. Food and Drug Administration. Schulz said Storz Medical is working with its New York-based distributor, Soterix Medical, to apply to the FDA to use the device for investigational purposes in the U.S., and to obtain approval of an institutional review board (IRB).
Nevertheless, Kawliche said Soterix sold him the device for around $100,000, with Storz Medical’s approval, and told him that the FDA would allow him to treat patients if he conducted a study that followed Beisteiner’s methods and worked toward obtaining approval of the study from an IRB. He didn’t have the resources to carry out this study, Kawliche said, but he began treating patients after consulting a lawyer. (The lawyer denied telling Kawliche he could treat patients with TPS.)
Study sponsors typically have to get IRB approval before studying medical devices on patients to ensure that experiments are conducted ethically and that patients are properly informed of the potential risks and consent to participate in a study. Proceeding without such approval “is not permitted,” said Diana Zuckerman, president of the National Center for Health Research.
Storz Medical initially told STAT it shipped one Neurolith to the U.S., to Soterix, so that it could be used for demonstration purposes. Schulz later acknowledged that Kawliche may have purchased this device when STAT pointed out that Kawliche had posted multiple images of himself on LinkedIn posing with a Neurolith at his Florida clinic over the past year.
Schulz said the company has many users of its devices across the world so “it’s impossible to know what everyone is doing. But he [Kawliche] seems to be a special case.”
Storz Medical and Soterix claim they were not aware that Kawliche was treating patients and that he shouldn’t have done so. Yet both were in regular contact with Kawliche and multiple Storz Medical employees reacted to and commented on social media posts of the Florida clinician describing his experience using the device on patients.
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