The User Perspective
The recent National Academies Workshop on Brain-Machine and Related Neural Interfaces featured presentations from a number of neurotechnology pioneers who have advanced the field over the last 20 years [see conference report, p7]. But in our view, one of the most meaningful presentations came not from a researcher, but a user of neurotechnology.
Brandy Ellis, a patient with treatment-resistant depression, related her experiences with an implanted DBS system. Ellis, who has had the implant for 11 years now, described her futile efforts to obtain effective treatment with traditional therapies. She consulted with a neuropsychologist, who performed cognitive and behavioral therapy. She saw multiple psychiatrists, who prescribed 25 different medications, and she was even an inpatient at McLean Hospital in Boston, MA, where she underwent 24 ECT sessions. Nothing worked. “I was being fired by doctors left and right,” she quipped.
Ellis decided to participate in one of Helen Mayberg’s clinical trials of DBS of Cg25 for TRD at Emory University in 2011. She began to respond after six months, though she noted that most of that improvement occurred at the end of the six-month period. It took a full year for her to be in remission.
In her talk, Ellis highlighted several user issues that manufacturers of implanted neurotechnology devices—and regulators of those devices—should take into consideration. Because of her level of despair, Ellis was only interested in an open-label trial. “I did not feel I could take the risk of a sham or placebo trial,” she said. “I could not afford the time for something to potentially not work. It was a terminal condition at that point.”
Ellis stressed that she is completely dependent on her DBS device. “There will be no going off grid for me,” she said. She worries that at some point in the future she may not be able to get a replacement battery if her vendor is unable to supply her. “I don’t have the option to select a different device,” she said, arguing for more cross-compatibility among neurotech vendors.
Ellis also worries that there’s no security on her device. “I’m wholly dependent on the fact that nobody in my life wants to hack my device. As I become more familiar with cyber security, I would like manufacturers to build that in from the ground up,” she said.
Neural engineers designing the next generation of implanted devices should do everything they can to consider the preferences and usability factors that will be important to the patients they serve. When the life and well-being of the patient is at stake, these considerations may outweigh factors like competition, cost, and clinical trial design.
James Cavuoto
Editor and Publisher
