August 31, 2018 | August 2018 issue
August 31, 2018 | More than 600 clinicians, research scientists, and industry representatives gathered in Times Square New York City for the inaugural summer series joint meeting between the North American Neuromodulation Society and the NY Neuromodulation Society. “It is two cultures coming together,” said event co-chair, Marom Bikson. “The merging of the cultures is both on the technical and clinical sides. Our success factor is centered around a good program committee and bringing the most relevant issues forward.”
This was apparent in the variety of sessions and discussions at the event. On display and on the agenda was a myriad of neurotechnology devices from experimental noninvasive treatments to traditional implantable therapeutics.
Participants described new opportunities in implantable therapies like SCS and DBS. Psychiatric conditions are ripe targets for brain stimulation therapies. Helen Mayberg of Mount Sinai expressed some caution as she reviewed the issues around the failed BROADEN trial. But she also pointed to some opportunities that may be explored since DBS represents just one treatment along a continuum of care for severe depression. Martin Figee, also from Mount Sinai, highlighted results from a 37-subject trial using adaptive DBS for the treatment of OCD in which 60 percent of responders experienced a reduction in compulsivity, mood, and anxiety.
The role of SCS in responding to the opioid crisis was a key point of discussion at the meeting. Participants raised a number of issues from a socioeconomic perspective, such as reducing the number of device explants, optimizing the timeframe for device replacement, and perfecting treatment protocols for chronic pain. Jonathan Carlson, an Arizona pain physician, presented evidence from key trials like SUNBURST in which 51 percent of patients decreased their use of opioids while 26 percent stopped taking them completely.
As reported in The Market for Neurotechnology 2018-2022, one of the fastest growing segments of the neuromodulation industry is transcranial electrical stimulation. There was lively debate among the attendees around the validity and efficacy of these devices. Heidi Schambra of New York University expressed this in a breakout session centered on the advances and challenges of TES. “In clinical trials, variables are not documented. We need to do a better job in rehab and it is an important step that we tend to ignore.”
This theme was also debated on stage in a session on the influence of brain stimulation in sports performance. A diverse panel of athletic coaches, exercise physiologists, and professional athletes offered conflicting points of view. The evidence for performance enhancement was considered by some to be insufficient. But the prospect of improving an athlete’s training regimen in a low risk manner was appealing to other presenters.
In another session focused on neurorehabilitation, there were several presentations demonstrating that tDCS has no impact on neural recovery when compared to sham. However, Leonardo Cohen of NINDS cautioned that we need to be “skeptical but respectful” in our conclusions in this space.
Novel strategies for applying noninvasive therapies also surfaced during the session discussions. Doug Bremner of Emory University presented his work using closed-loop transcutaneous VNS for the treatment of post-traumatic stress. Sven Vanneste from the University of Texas Dallas highlighted his work using trigeminal and VNS for treating phantom percepts. A panel session was also dedicated to noninvasive applications for reaching deep into the brain substrates with the use of ultrasound, multiplexed stimulation waveforms, or Soterix’ HD-tDCS.
Some of the discussions moved away from the treatment of medical conditions and toward enhancing healthy individuals in wearable technologies for the wellness market. Mindfulness is not a term often associated with neuromodulation but it was prevalent at this event. Each morning there were sessions for guided meditation with the option of electrically stimulated meditation. Bashar Badran from the University of New Mexico presented his work enhancing meditation with brain stimulation. Fidel Vila-Rodriguez of the University of British Columbia looked at combining yoga with tDCS, while Tracy Dennis of CUNY explored neuromodulation for stress-reduction, and Michael Nitsche from Georg August University explored low current stimulation to enhance self-awareness in the dream state. These may be non-traditional means in the neuromodulation segment but potential viable market opportunities.
The business of neurotechnology was peppered into the discussion panels. In a lively discussion about the future of neurotechnology led by Erika Ross from Cala Health, human enhancement was a point of caution. Ben Pless of Pivotal Design Labs urged researchers to have better evidence in the arena of transcranial brain stimulation to avoid the “snake-oil” perception. Jonathan Charlesworth from Fitbit described opportunities to enhance sleep behaviors in heathy individuals as well as stress reduction.
Al Emondi of DARPA raised the issue of offering neurotechnologies to the abled-bodied population while also pursuing therapeutic effects to those living with medical conditions. Ross posed the question of the missing components in the development ecosystem of technologies. In response, Ritu Kapur from Verily brought up the need to “have outcome measures that we believe in.” Identifying biomarkers that test different stimulation parameters quickly can be a transformative development. Leslie Bottorff of GE Ventures expressed cautioned about new pricing models for DTC devices. She stressed the key role that consumer perceptions will play when it comes time to pay out of pocket for new devices. The evolving regulatory environment was also a topic of discussion throughout several of the sessions. The FDA has set a December 2020 target for achieving a majority of novel device introductions taking place in the U.S. instead of foreign markets. This shift in the neurotechnology market can have lasting impact on access to these novel therapies.
