Spring 2018 Update to Clearly Present Foundation Stakeholders

Dear Friends of Clearly Present

I am writing to provide an update on the recent accomplishments, progress and activities of the Clearly Present Foundation. As you know, our goal is to foster the advancement of scientific knowledge and therapy availability for non-invasive brain stimulation as a safe and effective treatment for some of the core functional difficulties experienced by individuals on the autism spectrum.

Our informal consortium of neuromodulation and autism experts have met annually for the last four years as the TMS Therapy for Autism Consensus Group. The purpose of these meetings has been to disseminate science-based knowledge and to combine that with perspectives of individuals and caregivers living with autism, with medical industry executives, and with members of the venture and entrepreneurship community.  Feedback from participants at these meetings has been very positive. Eleanor Cole, who was formerly at the University of York and now is at Stanford with Nolan Williams, has volunteered to take on the job of summarizing the 2017 meeting, which will be shared with you and submitted to a journal.

2018 marks a shift in focus for the Clearly Present Foundation. This year we will not be holding a TMS Therapy for Autism Consensus Group meeting. In former years we scheduled these meetings to coincide with the International Meeting for Autism Research, which was a convenient gathering point. But this year, that meeting is being held in Rotterdam. Another reason is that while making progress on the underlying brain science of autism is extremely important, including steps to develop an understanding of target mechanisms and underlying pathophysiology, it felt as if the efforts of the Clearly Present Foundation would be better used in encouraging and coordinating a feasibility study of TMS as a treatment for autism.   

Thus, in 2017 we embarked on a plan to work towards therapy availability directly.  This year, we plan to use our resources to hold a launch meeting for the leaders of our planned feasibility study and the scientific advisory board.  

The Clearly Present project has three phases: 1) a feasibility trial; 2) a full clinical trial as a basis for FDA approval; and 3) working toward broad availability of the treatment by supporting awareness, adoption and reimbursement. The first phase, the feasibility trial, will cost $4.2 million; $1 million is now pledged.  Total estimated cost for all three stages is $25 million. The overall goal is access to an effective and inexpensive therapy that can make a difference in the lives of those with autism.  

We are now conducting site evaluation interviews with those university-based researchers who expressed interest in being part of the study. We are also having detailed discussions with several TMS device manufacturers before selecting a device partner for the study. A detailed protocol synopsis and budget have been developed and vetted by industry executives with experience in conducting therapeutic brain stimulation clinical trials.  

We are deeply grateful to the Weitz Family Foundation, whose members have shown the vision and leadership to pledge to support a quarter of the expense of the feasibility trial when matching funds are secured. We are in the process of conversations with other potential significant donors, with the plan to form a group of four to twelve donors that would support the first phase, namely the feasibility trial.

In closing, let us all take a moment to remember why this project is so important. New data recently released by the CDC estimates the prevalence of autism, measured by 8 year-olds diagnosed, to be 1 in 59. Of that group, 70% are now categorized as high-functioning, and thus potential candidates for TMS as a therapy.  Children diagnosed with autism often endure a lifetime of social and functional difficulties that limit their opportunities and impose huge costs on them, their families, and society at large.

When my son was part of a clinical trial with Harvard physicians, I saw that 40 seconds of non-invasive brain stimulation resulted in his being able to do things he had not done before, like turning his body to face the person talking, and being more able to take in the opinion of others, and to adapt calmly when a situation changed. He also had a small but statistically significant improvement in a test of his ability to perceive emotions in others’ faces. John Robison describes the changes he experienced from TMS in his book Switched On: “It rolled the boulder of social disability out of my path.”

Thank you for your care and concern for this work. In my experience it offers the chance at a more engaged and connected life for people with autism.


Kim Hollingsworth Taylor
Founder and CEO
Clearly Present Foundation