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Read our disclaimer for details. Last Update Posted : November 30, See Contacts and Locations. Study Description. The study's goal will be achieved through 3 specific aims: Demonstrate device capability to selectively and predictably engage distinct brain networks Delineate depression-relevant networks and demonstrate behavioral changes with network-targeted stimulation Demonstrate that chronic DBS using steered, individualized targeting is feasible and safe for reducing depressive symptoms.
Detailed Description:. Treatment-resistant depression TRD is a major worldwide burden. For the Broaden trial, the FDA had set this bar at a likelihood of success of one in The futility analysis calculated its likelihood of success as one in six.
Modest odds, to be sure, but it easily cleared the FDA bar. The trial could continue. A trial sponsor can stop a trial at its own prerogative.
Jude now did so. Sometime in , the company informed the Broaden team—Mayberg and dozens of cooperating researchers at the 15 research centers—that it was stopping the trial. Jude never said why. Perhaps they had their own kill point somewhere north of one in six. In any case, they stopped the trial. Jude and then Abbott, a larger company that later bought St. Jude, would continue to pay for the care of the implanted patients who wanted to either continue or have their devices removed.
But they would implant no more patients, and they would cease their attempt to get FDA approval. The first reaction to this halt—to the end of this keenly anticipated test of a depression treatment hailed as the most original and promising in decades—was crickets. Jude said nada. No one associated with the study publicly marked its halt. Once again, the industry is left to pick up the pieces as a promising new technology gets set back by what could be many years.
A handful of journalists and bloggers who had followed the trial soon waded in, some more carefully than others. These comments included numerous remarks from about 10 to 12 people identifying themselves as patients in the trial. Somewhere from seven to nine commenters said the treatment had worked for them or their spouses; several called it lifesaving.
Others drew on mischaracterized or mistaken reads of the sparse data to paint the trial as a massive failure. Speculation filled the data void. Mayberg, reading such coverage and comments and hearing of rumors flying around among colleagues, was appalled. Jude stayed mum. Before long, colleagues at conferences were offering Mayberg condolences. Others said similar things.
Mayberg began to worry her entire research program was endangered. The patients got better. As expected, it failed to help many. In the first year, 10 of the 90 patients left the study and four had their devices removed , for reasons ranging from worsening depression to a suicide attempt.
Also as expected for a surgical intervention in so depressed a population, some experienced side effects and complications of the sort mentioned by commenters on the Neurocritic post. Overall, at least nine people reported increased depression, six got infections, and several more suffered side effects such as headaches or postoperative discomfort or pain, either at one of the surgery sites or from a condition called bowstringing, in which the battery leads running under the skin between chest and skull bond with tissue and create pulling sensations.
Three patients grew more anxious. One considered suicide. One tried it and lived. Two tried it and died. Perhaps the best known of those with complaints was Steve Ogburn, an architect who was implanted at Stanford in late November and soon experienced complications.
None of these, he says, were relieved when Stanford removed the implants, wiring, and battery in December Lisa Wick, an elementary-school teacher from Minnesota, also suffered complications, but hers developed seven years after what had otherwise been a successful implant. When she was first implanted, in , Wick had been badly depressed for years despite psychotherapy, several antidepressant regimes, and multiple rounds of electroconvulsive therapy.
It was like that part in The Wizard of Oz where it goes from black-and-white to color. I felt better right away. They give a taste of how various, variegated, and rich these cases can be, how fickle is fate—and biology. They speak to the tremendous stakes involved in aiming a treatment so intrusive at an affliction so crushing.
And under those terms, each story represents but one point of data among 90; Wick and Ogburn were dots near the opposite ends of a spectrum. But what about the treatment? In the months and years after the halt, as data accrued from patients who continued with the treatment, it became clear that more and more of them were moving toward and past the 40 percent improvement threshold; some were even in remission.
Most of the researchers had access to reports about the data as it accrued. But the first presentation of results—a presentation sharply constrained by journal guidelines, St. The paper, finally published in The Lancet Psychiatry , presented patient data through 24 months of activation. When tracked for two years instead of the six months used for the futility analysis, the percentage of active-treatment patients whose depression scores dropped by at least 40 percent more than doubled, to 50 percent of all those in the original active group.
The remission rate also rose, from 10 percent at six months to 31 percent at 24 months. Also encouraging was the response of patients in the control group when their implants were activated after six months, for they continued to roughly match that of the group whose implants had been active from the start. Jude nor Abbott has published the individual-patient data. The two-year results for these intensely sick people—half reaching the 40 percent improvement threshold, almost a third in remission—stand sharply at odds with the six-month scores.
What we have here is a failed clinical trial—of a treatment that seems to work. One is why the trial failed even though the patients got better. The purpose of this study is to test a personalized approach to brain stimulation as an intervention for depression. The researchers will then use small electrical impulses to alter that brain activity and measure whether these changes help reduce depression symptoms.
This study is intended for patients with major depression whose symptoms have not been adequately treated with currently available therapies.
It is currently FDA approved to treat patients with epilepsy. The study will test whether personalized responsive neurostimulation can safely and effectively treat depression. This is a single-center 3-stage feasibility study of personalized closed-loop stimulation for treatment resistant Major Depressive Disorder. Stage 1 of the study will involve surgically implanting small, thin electrodes in brain regions that regulate depression in order to identify personalized treatment sites.
The researchers will test stimulation in the different brain regions and their effect on depression symptoms. The electrodes will be surgically removed at the end of Stage 1. Researchers will use information from Stage 1 to decide where to implant the electrodes of the RNS System. Stage 3 will be 12 months long and will involve turning ON and OFF the intervention to test its effectiveness.
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