This story describing research on deep brain stimulation (DBS) to treat Alzheimer’s disease centers on a phase 2 safety trial that was the subject of a news release evaluated by HealthNewsReview.org in March.
The study involved a procedure in which an implanted neurostimulator delivered electrical signals to the fornix area of the brain to help regulate abnormal signals in patients with potential mild Alzheimer’s. A similar procedure is used to treat Parkinson’s disease and essential tremor.
The story provided some compelling details, but could have used a jolt of skepticism as it examined the challenge of applying a treatment that works for some diseases to an altogether different medical condition. Like the release, the story didn’t describe serious adverse effects of the treatment. The story also didn’t include costs and conflicts of interest. Moreover, its positive tone about the prospects of this treatment for Alzheimer’s doesn’t seem warranted by the evidence and at times strays into editorializing.
DBS is a procedure used to treat a variety of neurological conditions by delivering electrical impulses to specific areas of the brain through implanted electrodes. The possibility of using it treat Alzheimer’s disease, an irreversible, progressive brain disorder that slowly erodes memory and cognitive skills, seems like a natural area of inquiry.
The story does not discuss what this treatment might cost, even though DBS is widely used for other conditions. A DBS surgery for Parkinson’s, for example, can cost a minimum of $35,000, including hospital and physician fees, according to the National Parkinson Foundation.
It’s unclear what if any benefit DBS might offer for Alzheimer’s patients, a point that could have been made more explicitly. There were no quantified benefits included, instead the story states that results for the phase 2 study were “mixed but encouraging.” It does not explain that the trial was aimed at determining only the 90-day postoperative safety of the procedure, not its efficacy, and that it included only patients with mild Alzheimer’s. It further states that after one year there “were no significant differences in cognition” between the treatment groups, but differences “may take time to become noticeable” because the disease progresses slowly.
While some researchers hope DBS might be able to slow progress of the disease, the story suggests it might actually reverse memory loss. It likens DBS to “retrieving memories by hot-wiring the brain” and leads with an anecdote about a 63-year-old women with Alzheimer’s who retrieved a latent childhood memory as a result of deep brain stimulation, though apparently under a “lofty voltage” only safely achievable in a hospital. The story states that a finding of increased glucose utilization in patients who have received brain stimulation “could mean there’s a way to overcome some of the damage from Alzheimer’s.” Given there was no clinical correlation, it doesn’t seem relevant, and we’re not sure why it was included as a sign of benefit.
The story states that the study showed “both the surgery itself and DBS of the fornix appear safe” and “no serious, long-term side effects were seen in either patient group, supporting further research in the field.”
But the story doesn’t mention that 26 (61.9%) of the 42 patients in the study experienced one or more adverse effects. Five patients (11.9%) experienced one or more serious adverse effects, and four of those patients required a return to surgery.
The story states that the phase 2 trial was a randomized, blinded trial involving 42 patients, but it does not adequately caution readers about limitations, such as its focus on safety and inclusion of only patients with mild Alzheimer’s. The story cites other “mounting evidence” in favor of DBS, but supports that idea with one study that did not include Alzheimer’s patients, one study that included just six Alzheimer’s patients, and one study that was conducted on rats.
Despite skimpy efficacy data and clear risks, the story calls early findings “intriguing” and is bullish on more research: “Yet the fact that the therapy can in some people rescue recollections — albeit random ones — and possibly induce new neuron growth in memory regions of the brain seems reason enough to pursue it further.”
To us, this seems like editorializing.
We did appreciate, however, a skeptical source who says, “Unfortunately, [the findings] suggest that the therapy may not be as robust as initially proposed” and other statements of caution.
No disease mongering here.
The story cites multiple sources but fails to mention research funding or potential or conflicts of interest. Notably, it omits the fact that one researcher at the center of this story, University of Toronto neuroscientist Andres Lozano, M.D., has a financial interest in the deep brain stimulation as co-founder and director of Functional Neuromodulation Inc, which makes the deep brain stimulation device.
Are there alternatives to deep brain stimulation for treating Alzheimer’s? This story doesn’t say.
The story acknowledges the preliminary nature of the research, but we’d have liked to see it near the top rather than in the third-to-last paragraph, which states: “DBS for treatment of Alzheimer’s and other dementias is a field in its infancy. Unlike on TV, in all likelihood it won’t be widely used anytime soon to retrieve specific memories.”
The story appropriately states that deep brain stimulation is approved by the Food and Drug Administration to treat Parkinson’s disease, essential tremor and obsessive-compulsive disorder. It also included a description of research on DBS in dementia, which helps provide context.
The story does not rely solely on a news release.