Patient Number One is a thin man, with a scabby face and bouncy knees. His head, shaved in preparation for surgery, is wrapped in a clean, white cloth. Years of drug use cost him his wife, his money and his self-respect; hence before landing him in this drab yellow room at a Shanghai hospital; so facing the surgeon who in 72 hours will drill two small holes in his skull and feed electrodes deep into his brain.
The treatment deep brain stimulation has long use for movement disorders like Parkinson’s. Now, the first clinical trial of DBS for methamphetamine addiction is conduct at Shanghai’s Ruijin Hospital; hence along with parallel trials for opioid addiction. And this trouble man is the very first patient.
Just for addiction
Sun said he has served as a consultant for two Chinese companies that make deep brain stimulators SceneRay Corp. and Beijing PINS Medical Co. He has tried to turn Ruijin into a center of DBS research, not just for addiction, but also Tourette syndrome, depression and anorexia.
They argue that such human experiments are premature, and will not address the complex biological, social and psychological factors that drive addiction. Scientists don’t fully understand how DBS works and there is still debate about where electrodes be place to treat addiction. There is also skepticism in the global scientific community about the general quality and ethical rigor particularly around issues like inform consent of clinical trials done in China.
It would be fantastic if there were something where they could flip a switch, but it’s probably fanciful at this stage, said Adrian Carter, who heads the neuroscience and society group at Monash University in Melbourne. “There’s a lot of risks that go with promoting that idea. The failure of two large scale, U.S. clinical trials on DBS for depression around five years ago prompted soul-searching about what threshold of scientific understanding must be met in order to design effective, ethical experiments.
They’ve had a reset in the field,” said Dr. Nader Pouratian, a neurosurgeon at UCLA who is investigating the use of DBS for chronic pain. He said it’s “a perfectly appropriate time” to research DBS for drug addiction, but only “if they can move forward in ethical, well-inform, well design studies.
Battery pack in his chest
At 9 a.m. on a grey October Friday in Shanghai, Dr. Li drill through Yan’s skull and thread two electrodes down to his nucleus accumbens, a small structure near the base of the forebrain that has implicate in addiction. At 4 p.m. the same day, Yan went under general anesthesia for a second surgery to implant a battery pack in his chest to power the electrodes in his skull.
China’s studies have offer mix results. Sun and his colleagues have publish one case study; so describing a patient who use heroin and fatally overdose three months after getting DBS. But a separate pilot study publish in January by doctors at a military hospital in Xi’an show that five of eight heroin users stay off drugs for two years after DBS surgery.
Base on those results, SceneRay is seeking Chinese regulatory approval of its DBS device for opioid addiction; also funding a multi-site clinical trial targeting 60 participants. SceneRay chairman Ning Yihua said his application for a clinical trial in the U.S. was block by the U.S. Food and Drug Administration.
But in February, the FDA greenlight a small, separate trial of DBS for opioid use disorder, said Dr. Ali Rezai; so who is leading the study at the West Virginia University Rockefeller Neuroscience Institute. They hope to launch the trial in June, with funding from the National Institute on Drug Abuse.