Key takeaways from our investigation into the science behind an alternative autism therapy

In recent years, dozens of clinics in the U.S. and beyond have started offering an experimental treatment called magnetic resonance therapy, or MERT.

Developed and trademarked by a Newport Beach-based company called Wave Neuroscience, MERT is a version of transcranial magnetic stimulation, or TMS, which is approved by the FDA to treat major depression, obsessive-compulsive disorder and cigarette addiction. Clinics offering cash-pay TMS treatments for a variety of off-label conditions have proliferated in recent years. MERT, in particular, has become popular among families with autistic children.

Thousands of parents have sought MERT for their autistic children, often paying $10,000 or more for treatments and related expenses. The Times spent nearly a year evaluating research and interviewing psychiatrists and neuroscientists about the science behind MERT providers’ claims. Here are the key takeaways from our investigation.

There is minimal evidence that MERT works better than a placebo on autism’s core symptoms.

No large scientific studies show MERT is significantly better than a placebo in altering symptoms of autism, according to nine psychiatrists and neuroscientists with expertise in brain stimulation and autism. Wave Neuroscience, the therapy’s developer, has not conducted any clinical trials on MERT and autism.

Multiple researchers are currently examining whether TMS could improve certain symptoms of autism. But researchers interviewed for The Times’ articles said there isn’t yet enough evidence to recommend TMS as an autism therapy, or to say with confidence that it works for that condition.

“Off-label treatment can be just fine so long as there’s data to support this and the risks are low,” said Dr. Andrew Leuchter, director of UCLA’s TMS Clinical and Research Service. For autism, he said, “the evidence base is not very strong. … And I don’t think that there is sufficient evidence to recommend the use of TMS for the treatment specifically of autism.”

While many clinics feature glowing testimonials from satisfied customers, patient experiences with MERT run a broad gamut.

The Times spoke to parents who said MERT led to positive, lasting changes for their autistic children, improving their ability to communicate, concentrate and sleep through the night.

The Times also spoke to many parents who saw only minimal changes in their children’s behavior, or no changes at all. Others saw worrying behavioral regressions that persisted long after therapy was complete.

Without accompanying data, there is no way to know whether any patient’s experience with a treatment is typical or an outlier.

“If you go to a clinic website and they have dozens of quotes from parents saying, ‘This changed my child’s life in XYZ ways,’ that isn’t the same as evidence,” said Zoe Gross of the Autistic Self Advocacy Network (ASAN), a nonprofit group run by and for autistic adults. “If the main way something’s advertised is through testimonials, it may be because there isn’t research, or what research was done showed it wasn’t effective.”

ASAN is one of five autism advocacy groups The Times consulted that said there wais not enough evidence for them to recommend MERT as a therapy.

There is no evidence that MERT can reliably prompt changes in a child’s speech, sensory or communication abilities.

Several parents who sought the therapy for their children told The Times they were intrigued by providers’ claims that a majority of autistic patients in one study had better speech and eye contact after treatment.

Nine doctors and scientists with expertise in transcranial magnetic stimulation told The Times that there is, to date, no evidence to suggest that MERT or TMS can reliably prompt a nonverbal autistic child to develop speech, or to significantly alter an autistic child’s sensory and communication abilities.

According to Wave, the source of that claim is a small study of 28 patients that has not been published or vetted by independent scientists. But “small samples like this aren’t good for establishing the benefits of a treatment, conclusively showing safety or demonstrating that an investigational treatment is better than placebo,” said Christine Conelea, an associate professor at the University of Minnesota Medical School who runs the university’s Non-Invasive Neuromodulation Laboratories.

Following questions from The Times, Wave’s chief medical officer Dr. Erik Won said that Wave has asked the study’s authors to submit the study to a peer-reviewed journal. The company also asked the authors to release the manuscript on a preprint server, a website where scientists can post preliminary findings.

“We need to get that publication out so that people can make informed decisions,” he said.

When evaluating claims about any therapy or treatment, patients should prioritize results from randomized controlled trials above anecdotes or testimonials.

Medical research follows a hierarchy of evidence. At the bottom are anecdotes and observations: valid points of information that alone aren’t enough to draw broad conclusions.

Above that are observational studies that collect and analyze preexisting data in a systematic way. And at the top are randomized controlled trials, which are designed to eliminate as much bias as possible from the experiment and ensure that the thing being studied is responsible for any changes observed.

“Families need to know that there is this gold standard for studies — to make sure that something works to help people with autism, it needs to have what’s called a randomized controlled trial,” said Alycia Halladay, chief science officer at the Autism Science Foundation.

What does Wave Neuroscience say about MERT?

Wave’s chief medical officer says the company is dedicated to helping people with autism and is working to obtain funding “for further studies and ultimately an FDA indication.”

Won argued that the need for new autism therapies is strong enough to justify moving forward with new commercial options before rock-solid evidence is available.

“Academics pointing towards insufficient evidence for clinical adoption may not represent a true reflection of clinical utility in a population where there are very few therapeutic options, great suffering and a willingness of physicians and patients to seek innovative treatment choices with diligent clinical care and oversight,” he said.

Criticisms of the treatment’s pricing were “not a reflection of Wave Neuroscience,” he added, but rather “seem to be objecting to the realities of the healthcare market.”