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Serious harms from deep brain stimulation completely ignored in PR release

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IMAGE: Dr. Francisco Ponce of the Barrow Neurological Institute performs Deep Brain Stimulation. view more

Credit: Barrow

Neurosurgeons at Barrow Neurological Institute in Phoenix are involved with testing the viability of deep brain stimulation (DBS) to treat Alzheimer’s disease, a disorder that currently has few treatment options. Results from the Phase 2 study, reported in the Journal of Neurosurgery on Dec. 18, 2015, demonstrated the safety of DBS in Alzheimer’s patients.

A neurosurgical procedure in which an implanted neurostimulator delivers electrical signals to specific areas of the brain to help regulate abnormal signals, DBS is currently only approved in the U.S. for the treatment of Parkinson’s disease and essential tremor. However, its use is being researched for a number of conditions, including epilepsy, depression and bipolar disorder. Francisco Ponce, MD, Director of the Barrow Center for Neuromodulation, believes there are potential applications for Alzheimer’s disease – the most common form of dementia – as well. Whereas in Parkinson’s disease and essential tremor, the target for the electrodes are nodes within the motor circuits, the Alzheimer’s study targeted the fornix, which is part of the memory pathway.

“There are more than five million Americans living with Alzheimer’s, and yet there are few promising pharmacologic treatment options for this progressive disease,” says Dr. Ponce. “Previous pilot studies researching the use of DBS in Alzheimer’s have indicated the potential to slow cognitive decline in some patients, and have even shown metabolic changes in the brain that may slow the progression of the disease.” Barrow Neurological Institute is part of Dignity Health St. Joseph’s Hospital in Phoenix.

The ADvance Trial, using a device from Functional Neuromodulation, Inc., is aimed at evaluating the safety, efficacy and tolerability of DBS in this patient population. Initial research took place between 2012 and 2014 at six hospitals throughout the U.S., including Banner Alzheimer’s Institute in Phoenix and Banner Sun Health Research Institute in Sun City, as well as one institution in Canada. During the trial, 42 patients with mild Alzheimer’s disease underwent the surgical procedure and were closely monitored for adverse effects.

Overall, there were no programming-related adverse effects, unanticipated adverse device effects, reported neurological deficits or instances of mortality in the study population. Adverse effects such as headache and infection occurred in 11.9% (5 of 42) of the patients in this study, consistent with rates reported in other DBS trials.

“The first phase of this study was designed to evaluate the 90-day postoperative safety of this particular surgical method. While the study was relatively small, we believe the data suggest that DBS surgery targeting the fornix can be performed safely in this patient population. The hope is that our positive surgical experience will help pave the way for future research into DBS and Alzheimer’s,” says Dr. Ponce.

Dr. Ponce adds that the next step is evaluating the efficacy and longer-term safety of the treatment, which will not be known until the last patient completes the two-year evaluation later this year.

Barrow neurosurgeon helps pave way for deep brain stimulation and Alzheimer's

Our Review Summary

Illustration: Deep brain stimulation electrode placement reconstruction. Wikipedia

Illustration: Deep brain stimulation electrode placement. Wikipedia

This news release summarizes the results of a phase 2 safety trial of a deep brain stimulation device on patients with potential mild Alzheimer’s disease. This is an off-label trial of a device currently used to treat Parkinson’s disease and essential tremor. The device is an implanted neurostimulator that delivers electrical signals to specific areas of the brain, in this case, the fornix which is a memory pathway. The trial was intended to test the 90-day postoperative safety of this particular surgical method. We were disappointed to see that the news release reported only mild side effects and not the serious harms which required several of the study group patients to have corrective surgery.

 

Why This Matters

As the U.S. population ages, Alzheimer’s disease becomes more widespread. About 5 million Americans are currently living with Alzheimer’s, according to the Centers for Disease Control and Prevention. There is a need for more options to treat this disease as well as a need for greater understanding of how to prevent the disease, or stave it off until as late as possible. Current drug treatment methods are not successful in reversing this progressive disease, nor can they stop the progression.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

There is no discussion of the cost of this procedure or the maintenance costs of the device. These numbers should be well-known as the device is currently used in Parkinson’s patients and others. An article published in WebMD in 2011 estimated the surgery runs between $30,000 and $50,000.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Applicable

This release summarizes a stage 2 trial looking primarily at safety following the first 90 days of the trial. It did not report on whether or not the device implantation improved cognition or slowed or halted decline. The news release says Dr. Ponce will report on potential efficacy after the last patient finishes two years of the study. The release was appropriately mum on this point and didn’t make predictions/guesses based on incomplete and preliminary data.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

The release only reports the mild adverse effects, including headache and infection, which occurred in 11.9 percent or 5 out of 42 patients. It was a glaring omission not to report serious side effects that required some of the patients to undergo corrective surgery following the procedure. According to the published study:

“Twenty-six (61.9%) patients experienced 64 AEs related to the study procedure, of which 7 were serious AEs experienced by 5 patients (11.9%). Four (9.5%) patients required return to surgery: 2 patients for explantation due to infection, 1 patient for lead repositioning, and 1 patient for chronic subdural hematoma.”

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

The news release doesn’t tell us that the study was double-blind, randomized, and controlled, which it was. This is important to include to be able to ascertain the study’s quality.

And while there are copious amounts of data in the published study, most is not included in the news release. The release doesn’t convey the number and severity of adverse events that occurred. The overall number of events at almost 62 percent was very high. According to the published study, 9.5% required a return to surgery–not a small thing. While the surgeon-investigator feels that the study “demonstrated the safety,” we think that’s debatable.

Finally, there’s no background or context provided for lead author Dr. Ponce’s claim that deep brain stimulation has “even shown metabolic changes in the brain that may slow the progression of the disease.”

Does the news release commit disease-mongering?

Satisfactory

There is no disease mongering here. Alzheimer’s disease is increasing in prevalence among a population that is living longer than ever before. The impact of the disease on the patients, their families and societies is enormous.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

There is no mention of the funding sources. ClinicalTrials.gov shows that the trial was sponsored by Functional Neuromodulation, Ltd. the device being studied. At least one author is associated with Functional Neuromodulation, Ltd.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

The release briefly mentions the fact that there are “few promising pharmacologic treatment options,” but there is little discussion of their use or efficacy. Except for that, there is no mention of other treatment. Based on growing evidence, there’s increasing support for the idea that prevention may be the best bet to impact Alzheimer’s and other forms of dementia.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

The release states that the device is only approved for use in patients with Parkinson’s disease and essential tremor. It’s available to those patients, and only for research in other conditions.

Does the news release establish the true novelty of the approach?

Satisfactory

The release implies novelty by stating that the research “helps pave the way” for a new treatment option. Deep brain stimulation is used for other brain disorders, so it is obviously not a new device or new surgical approach, and the release makes this clear. However, as an approach to treat Alzheimer’s disease it is novel.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

There is no explicitly unjustifiable language in this story, however, one wonders why this story was written at all. True, it reports that results of a phase 2 trial “suggest that DBS surgery targeting the fornix can be performed safely in this patient population.” For reasons described under the Harms section, for which we already gave the release a failing grade, we wonder if this news release accurately portrayed the device’s safety, and if the study really met its safety endpoint.

Total Score: 4 of 9 Satisfactory

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