More than 15 years after starting a similar trial (and nine years after cutting that trial short), Abbott will once again implant electrodes into people’s brains and send up electrical pulses in an attempt to tackle treatment-resistant depression.
On September 4, the medical device company announced a new double-blind, randomized clinical trial of its Infinity deep brain stimulation (DBS) system for patients who have failed a minimum of four different antidepressant therapies.
DBS systems like Infinity have long been used to adjust abnormal activity in areas of the brain that impact Parkinson’s and essential tremor. Infinity has had FDA approval to treat those conditions since 2016.
The FDA granted Abbott breakthrough device designation in 2022 to test if Infinity could help treatment-resistant depression, but so far, no DBS treatment has received FDA approval for this purpose.
“This is a very exciting moment,” Brian Kopell, a principal investigator of the study and director of the Center for Neuromodulation at Mount Sinai Health System in New York, told Healthcare Brew. “As a field, we don’t get very many opportunities to change people’s lives in this way.”
How it works. DBS works essentially like “a pacemaker for the brain,” Kopell said.
Just as pacemakers send targeted electrical signals to readjust heart activity, DBS sends electrical signals to the brain via electrodes that are connected to a stimulator implanted in the chest. Kopell said the new study has been designed to target a region associated with depression—specifically, white matter in the subcallosal cingulate region of the brain, for the neuroscience fans out there.
Abbott
The researchers aim to recruit 100 adults aged 22–70 and implant the device in each participant, but they said they will only activate it in half of the subjects for the first year, according to the study record on clinicaltrials.gov. Depression symptom severity will then be compared between the two groups at one year to see if the device had a significant effect.
Second time’s the charm. If you’re getting déjà vu, it might be because St. Jude Medical—which Abbott acquired in 2017—did a similar clinical trial starting in 2008 on the same region of the brain using Infinity’s precursor, the Libra XP DBS.
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But after six months, the researchers reported that there was no significant difference in depression symptom reduction between the experimental and control groups, prompting St. Jude to end enrollment early and conclude the study in 2015, according to clinicaltrials.gov.
Since then, however, in a subsequent study, researchers from Emory University School of Medicine found that deep brain stimulation of the subcallosal cingulate region was associated with improved depression severity in people with treatment-resistant depression. Health systems including NYU Langone Health already offer the experimental treatment for treatment-resistant depression, with a disclaimer that the treatment is not FDA-approved for this purpose.
Looking forward. Kopell emphasized that Abbott’s original test was not a “failed trial” and didn’t prove that the treatment didn’t work; there was just no difference detected.
“The way we designed the trial and the way we executed it at that time did not have a high chance of success,” he said.
Abbott has redesigned this study in a way that Kopell hopes will increase its chances of success for the 30% of people with major depressive disorder that are treatment-resistant. For instance, the researchers of this new study—for which recruitment is expected to start soon—plan to measure outcomes at 12 months instead of six following evidence that the device’s effects grow over time, according to Kopell. The study is expected to conclude in April 2029.
There’s also technology available now that didn’t exist then, such as diffusion tensor imaging, which will allow more accurate electrode targeting to make the procedure more consistent among patients, Kopell said.
“Everybody involved in this is approaching this with a lot of humble excitement, and hopefully we will be successful here where before we have previously stumbled. Because, ultimately, our patients need it,” he said.