For the parents of autistic children, few treatment options exist other than powerful anti-psychotic medications or alternative therapies with little supporting clinical evidence. Brian Mullen is hoping to break this pattern with the Vayu Vest, a device that uses a treatment method called "deep pressure touch simulation," one of the most well-established alternative therapies. Mullen hopes that his device will become the first FDA-approved medical device to treat autism.
"If you look at other diseases, engineering has had a tremendous impact in improving quality of care, but there’s really no treatment for mental illness except deep brain stimulation and drugs," Mullen said. "We are trying to create the first evidence-based, insurance reimbursable medical device for mental health spectrum disorders."
Deep pressure touch stimulation was developed in the 1960s for people with autism and other conditions that make it difficult to process sensory information. Currently, the treatment method most commonly used by occupational therapist is to apply a weighted blanket to the patient experiencing sensory overload and agitation.
Mullen calls this effect "the squeeze," and likens it to swaddling a baby. This swaddling sensation has an observed calming effect on patients with autism and other spectrum disorders.
Mullen first noticed this technique as a PhD candidate under Sundar Krishnamurty in the Assistive Technology Lab at the University of Massachusetts. He initiated the first peer-reviewed clinical study demonstrating the efficacy of deep pressure treatment using weighted blankets.
Weighted blankets were his inspiration for the Vayu Vest, which is a sleek vest that uses air pressure to adjust the "squeeze" sensation around the chest and rib cage. The pressure of the vest is self-adjustable for people with less severe autism, but the vest can also be refitted to be externally adjustable for people who need constant assistance.
Mullen, partnered with Chris Leidel, applied for the University of Massachusetts competition called MassChallenge. They won first prize in 2011, using the prize money to create their company, Therapeutic Systems. The Vayu Vest immediately generated a lot of interest from patients and parents.
With the dramatic rise in diagnosed autism rates in the last decade, there has been an increased demand for an insurance-reimbursable therapeutic device, yet large medical device companies have not invested in this kind of technology.
"The big issue is that up until the last 5 or 6 years, it’s actually been a really small market," said Teresa May-Bensen, director of research at the Spiral Foundation, a non-profit research foundation looking into sensory issues. "Until people became aware of the autism ‘explosion,’ I don’t think the medical device people would have seen that as a need. Medical device communities are interested doctors and what doctors do, but they’re not into what occupational therapists do."
There are many small start-ups, funded by grants and venture capital, that have patented therapeutic devices using deep pressure stimulation to calm agitation in patients with autism.
Mullen and Leidel are determined to be the first to register their product with the FDA as a legitimate medical device. Mullen says he does not want the Vayu Vest to be confused in with many of the other "snake oil" therapies out there.
Mullen and Leidel are currently applying for the Small Business Research Funding Opportunities Grant, funded by the National Institute of Health, so that they can finally conduct the clinical trial that is required to apply for labeling indication with the FDA.
Mullen’s goal is to move away from a drug-treatment model and eventually to broaden the labeling indication of his deep-pressure stimulation device to other mental illnesses such as Asperger’s syndrome and schizophrenia.
"This market has been underserved and overlooked. We want to be able to provide the data for this population to make decisions about treatment based on evidence."