The Clearly Present Foundation aims to accelerate discovery about the value of non-invasive brain
stimulation to treat Autism Spectrum Disorder (ASD). The Centers for Disease Control estimates that 1 in every 68 children in the United States has some form of autism spectrum disorder. At present, there are no medically validated means to address the core symptoms of autism. The potential gains from a better treatment for autism are potentially enormous, for those with autism, for their families, and for society as a whole. We don’t want to ‘fix’ people with autism – they are family members and beloved friends, and they have a unique way of doing things that can benefit the world. It is our mission to bring about the full potential of people with autism through being more present.
The working approach of the Clearly Present Foundation is to seek quality work, transparency, and open communication. Publicity is welcome as long as it arises organically from the mission of the Foundation. The mission of the Clearly Present Foundation is perhaps best-viewed as proceeding in stages: immediate, near-term, and longer-term.
Immediate focus. The starting point for the Foundation in 2014 was the recognition that current research and accumulating evidence on the TMS for autism is happening at geographically separated institutions. Moreover, the research crosses a variety of professional boundaries. It is sometimes being carried out by those who are more research-driven, and sometimes by practitioners whose work is more based in treatment. Those who are studying TMS for autism include brain scientists, neurologists, psychiatrists, psychologists, child psychologists, autism experts, and others. Those familiar with the health care profession and academia will recognize that all of these different groups tend to operate in their own intellectual silos, and lines of communication between these groups had been essentially nonexistent.
Everett Rogers, a prominent scholar of how new ideas are communicated and spread, could have been talking about TMS for autism when he wrote: “In the era of the iPhone, Facebook, and Twitter we’ve become enamored of ideas that spread as effortlessly as ether. We want frictionless, “turnkey” solutions to the major difficulties of the world – hunger, disease, poverty. But technology and incentive programs are not enough. “Diffusion” is essentially a social process through which people talking to people spread an innovation,”
In this spirit, the starting point for the Cleary Present Foundation at its founding in 2014 was to begin building these lines of communication. The hope was to facilitate connections between researchers, and thus help spread information about plans, procedures, and findings.
The first step was to convene a conference held on May 13-14, 2014, in Atlanta. There were 23 attendees, who included the preeminent experts on TMS, including researchers from every group that authored published studies on therapeutic use of TMS in autism, along with an eminent psychiatrist who is both knowledgeable about autism and agnostic about TMS. Researchers from leading institutions such as Duke, Harvard, Johns Hopkins, the Mayo Clinic, UCLA and the University of Minnesota, were represented. Additionally, representatives from the National Institute of Mental Health, leading autism nonprofits and industry were in attendance. All participants, including the presenters and organizers, volunteered their time.
One tangible result of the conference was the co-authorship of a white paper, “Transcranial Magnetic Stimulation in Autism Spectrum Disorder: Challenges, Promise, and Roadmap for Future Research, which as published November 4, 2015, by Autism Research. The white paper enunciates the state of activity in this area along several dimension: to foster and conduct multidisciplinary exchange; to lay a groundwork for future trial to evaluate therapeutic potential of TMS; to facilitate other research relating to TMS and autism; to understand and document current off-label clinical use of TMS to treat autism; and to begin the process of raising public awareness and to develop educational material for physicians
Another result was that the Clearly Present Foundation has organized a series of follow-up conference calls, roughly every 12 weeks, so that the members of the group have a built-in opportunity to stay up to date with each other and to strengthen their connections.
The participants felt that the conference format was valuable, and so the Clearly Present Foundation organized a follow-up conference held on May 12 and 13, 2015, in Salt Lake City, A third annual conference is scheduled to be held on May 10 and 11, 2016, in Baltimore.
Along with these annual conferences and conference calls,the founder of the Clearly Present Foundation has continued reaching out to interested parties, including attending a conference on the subject at the National Institute of Mental Health, following up with researchers who are considering working in the areas, and holding conversations with the growing number of health-care providers who are beginning to offer TMS services for the FDA-approved uses, but who also have the capability to use the machines for off-label purposes like autism treatment. A website, blog, and Twitter feed have been established to publicize relevant news.
Near-term focus. The annual meetings, conferences calls, and outreach will continue. But in the near term, the Clearly Present Foundation is considering expanding its activities into some new areas.
- Along with in-depth professional meetings, it may be useful to hold some broader events aimed at other stakeholders in this issue, including more people with autism, their families, and practitioners who are considering offering this treatment.
- As additional research is published, it should become possible to identify key parameters for treatment that have demonstrated efficacy, which can then be communicated outside of the research context to and into the hands of qualified physicians so it can be available to help people.
- Follow up opportunistically on potential opportunities for fundraising. Additional funds could help the outreach activities of the Clearly Present Foundation directly. In some cases, the Foundation may be able to connect researchers who are looking at TMS as a potential treatment for autism with sources of funding for their research; in other cases, Clearly Present may act as a conduit for such research funding. Clearly Present will not seek to carry out any research directly. Clearly Present will accept financial support from other charitable foundations, private donors, government sources, and the medical technology industry. However, it will remain an independent voice that is not directly affiliated with others.
Long-term Goals. Of course, longer-term goals for the Clearly Present Foundation looking out 5-10 years depend on events: in particular, on an ongoing accumulation of promising evidence about TMS as a treatment for autism. Moreover, progress in the area of TMS as a treatment for certain core symptoms of autism will not be led by any single foundation or group, but instead will be a broad-based effort based on the work of many researchers, practitioners and nonprofit and for-profit organizations. But with those facts duly noted, it’s nonetheless useful to try to enunciate what some of the key elements of “success” would look like in this endeavor. Some examples include:
- Scientific validation that TMS works as a treatment for the symptoms of ASD
- Minimum of 50 papers published in peer-reviewed journals on therapeutic uses of TMS for autism
- Defined biomarkers or stratification to identify candidates for treatment
- Access to treatment – physician training and machine availability
- Top 20 medical schools and neurological residencies address in standard curriculum
- Physician education opportunities that would include continuing education courses, seminars, and perhaps a credentialing process
- Commercially available ‘standard’ machines that are capable of stimulation patterns applicable to autism
- Awareness of therapeutic option
- People with autism, parents have knowledge and realistic expectations: collaborate with autism service non-profits
- Pediatricians and general practitioners know about non-invasive brain stimulation as a therapeutic alternative and can provide referrals
- Critical mass and availability
- In each major metropolitan area or region there would be a critical mass of clinics with medical directors, physicians and technicians trained to use machines to treat autism and who have access to an appropriate stimulation machine
- Insurance coverage, which may require FDA approval of devices
- TMS as one of the services offered by 80% of autism centers of excellence
Kim Hollingsworth Taylor, founder of the Clearly Present Foundation, has a broad background in health care technology and financial services. She has worked as an employee, consultant or deal maker with a range of companies across the health care industry, including Medtronic, ALZA, United HealthCare, and Kaiser Permanente. She also worked as an equity research analyst for Wessels, Arnold and Henderson LLC, a national boutique brokerage house, where she covered emerging sectors of the healthcare services universe. She currently works as the chief financial officer for Medicom Health Interactive, a firm which helps health care providers and medical device manufacturers survey patients and guide them to follow-up care as needed.
Kim earned a Bachelor of Arts in English with Honors from Haverford College. She holds an MBA from the Graduate School of Business at Stanford University, with a specialization in healthcare economics. She also holds a Master of Arts degree in Pastoral Ministry from Santa Clara University. Kim has served as a Member of the Corporation for Haverford College and a board member for Faith at Work, now Lumunos. She is married with three children, one of whom has high functioning autism.
SCIENTIFIC ADVISORY BOARD
Professor of Neurology
Associate Dean for Clinical and Translational Research
Harvard Medical School
Director of the Berenson-Allen Center for Noninvasive Brain Stimulation at
Beth Israel Deaconess Medical Center
Joseph Campbell Professor of Child Psychiatry
Director of the Division of Child and Adolescent Psychiatry
Vice Chair of the Department of Psychiatry and Biobehavioral Sciences
UCLA Semel Institute
David Geffen School of Medicine at UCLA
SmartState Endowed Chair in Childhood Neurotherapeutics
Professor of Biomedical Sciences
University of South Carolina School of Medicine
Director of the Neuroplasticity and Autism Spectrum Disorder Program
E.P. Bradley Hospital
Assistant Professor, Department of Psychiatry and Human Behavior
Warren Alpert Medical School
Associate Professor of Psychology
Cognitive Neuroscience Unit
School of Psychology
Deakin University, Australia
“As one of the scientists devoted to this line of research, I am incredibly supportive of CPF for providing a mechanism for researchers to gather from all corners of the world, discuss issues and develop the necessary multicenter studies. When funding for such large scale studies is scarce, CPF has worked tirelessly to engage granting agencies and make this a reality.”
“This cause is amazing and will do a world of good. I totally support this effort.”
Al Horner, former Navy Seal and author of Not Me.
“CPF founder Kim Taylor is someone you want to hitch your cart to. With her integrity, commitment, intelligence and (hopefully) the support of a solid website, you can just sit back and enjoy the ride because good things are going to happen. The work being undertaken by the foundation will provide a legacy of hope for autistic children and their families.”
Meg Payne Nelson