Over the past decade, clinics have popped up throughout Southern California and beyond touting something called magnetic electron resonance therapy, or MERT. as a therapy for autism.
Developed by a Newport Beach company. Wave neuroscienceMERT is based on transcranial magnetic stimulation, a type of brain stimulation approved by the Food and Drug Administration to treat depression, obsessive-compulsive disorder, migraines and smoking.
Clinics licensing MERT say their registered version of the treatment can also produce “miraculous results” in children with autism, improving their sleep, emotional regulation and communication skills. A six-week course of MERT classes typically costs $10,000 or more.
The FDA has not approved MERT for this use. However, prescribing drugs or devices for conditions for which they are not approved, known as off-label prescribing, is a legal and common practice in medicine.
But when such treatments are offered to vulnerable people, a team of researchers argues in a new peer-reviewed study: editorial in the medical journal Transcranial Magnetic Stimulation, they must be evidence-based, clearly explained to patients, and rated in a way that reflects the likelihood that they will work as advertised.
Most clinics advertise TMS off-label as a treatment for autism. do not meet these standardssay the researchers.
Autism is “the largest non-indication business… [and] the one that is of greatest concern,” said Dr. Andrew LeuchterDirector of the TMS Clinical and Research Service at the University of California, Los Angeles.
Leuchter is one of three researchers with expertise in the field of TMS who recently called for the establishment of ethical guidelines regarding indirect marketing of TMS in a major journal in the field.
Written with Lindsey Oberman, Director of the Neurostimulation Research Program at the National Institute of Mental Health, and Dr. Holly Lisanby, Founder of NIMH. Non-invasive neuromodulation device and dean of the School of Medicine and Advanced Medical Technology at Arizona State University, the editorial singles out MERT as “an example of off-label TMS that has negligible effectiveness.”
“There is currently very limited scientific evidence that any form of TMS is effective and safe for improving core symptoms of language, social skills or behavioral disorders associated with [Autism Spectrum Disorder]”, the editors say. “Websites and other promotional materials that do not take into account this limited evidence base may create a risk of bias and the potential for false expectations.”
Dr. Eric Vaughn, Wave's president and chief medical officer, did not respond to requests for comment.
A Times investigation Last year, it was found that there are no large scientific studies demonstrating that MERT is significantly better than placebo at improving speech and communication problems associated with autism. Wave has not conducted any clinical studies on MERT and autism.
Won said last year that Wave is working to obtain funding “for further research and ultimately FDA approval.”
The websites of clinics offering MERT often feature written testimonials from parents describing what they perceive as positive changes in their children's mood or language ability after treatment sessions.
Without data, however, it is impossible to know whether a patient's anecdotal experience is typical or unusual, according to Zoe Gross of the Autism Self-Advocacy Network, a nonprofit group run by and for autistic adults.
“Beware of treatments sold to you with testimonials. If you go to a clinic's website and see dozens of quotes from parents saying, 'This has changed my child's life in every way,' that's not the same as evidence.” Gross told The Times last year.
A therapy can have only a 1% success rate but still generate dozens of positive reviews after thousands of people try it, she said.
For families who are unsure whether a particular commercial therapy might be helpful for their child, “seek advice from a clinician or autism scientist who is not affiliated with the agency providing the services, just to get a candid assessment of whether it will be helpful or worth the money,” said James McPartland, director of the Yale Center for Brain and Mind Health, which is currently studying the relationship between TMS and social perception in autistic adults. “Before you ask someone to spend resources on it, you need a certain degree of confidence. [that] it will be useful.”
