FDA Expands Parkinson, Tremor DBS Therapy With Magnetic Resonance-Conditional Labeling

Michael S. Okun, MD, Adelaide Lackner Professor and Chair of Neurology, University of Florida Fixel Center for Neurological Diseases, and National Medical Director, Parkinsons Foundation

Michael S. Okun, MD

The FDA has granted approval for an over-the-air software upgrade for all of the Infinity Deep Brain Stimulator (DBS) systems to allow for the delivery of magnetic resonance (MR)-condition labeling, among other features, for patients with Parkinson disease and essential tremor, according to Abbott.¹

The directional DBS is intended to limit the symptom’s effects and improve quality of life. The update simplifies the programming process, enabling physicians to use Apple hardware to “tune” each patient’s treatment for specific activities via Abbott’s Informity Programming Software.

This label update addresses the challenge of patient access to more advanced DBS therapy options due to the need for a future MR imaging (MRI). It allows for existing implanted devices to be upgraded via Bluetooth without the need for surgery, giving the MRI conditional labeling to the entirety of the system.

Binith Cheeran, MD, medical director of movement disorders at Abbott, called the approval a delivery on the company’s “promise to develop powerful features that strengthen the Infinity DBS system’s already patient-centric platform” in a statement.

“The ability to perform full-body MRI on DBS patients will provide important access to technology for many patients who may be suffering from health issues in other body regions that may require diagnostic imaging,” Michael S. Okun, MD, Adelaide Lackner Professor and Chair of Neurology, University of Florida’s Fixel Center for Neurological Diseases, and National Medical Director, Parkinson’s Foundation, told NeurologyLive. "There has been a particular need for this technological upgrade and it will likely improve the lives of those living with this device.”

In a 2012 clinical trial of the DBS system in 168 patients with Parkinson disease, led by Okun, the implantation of the therapy resulted in a mean increase of good quality ON time after 3 months, with a greater increase in the stimulation group (n = 101) at 3 months, a gain of 4.27 hours, compared to the control group (n = 35), which saw a gain of 1.77 hours (difference, 2.51; 95% CI, 0.87 to 4.16; P = .003).² The Unified Parkinson’s Disease Rating Scale motor scores in off-medication, on-stimulation condition improved 39% from baseline for the stimulation group, from 24.8 to 40.8.

Quality of life scores, as measured by the Parkinson’s Disease Questionnaire (PDQ-36) improved after 12 months by 38.4 points overall, with improvements observed in activities of daily living (9.4-point improvement), motor examinations (24.1-point improvement), and complications (4.61-point improvement).

Additionally, significant improvements were viewed in disability, measured by Global Outcome Measures, compared to the control group at 90 days. In the examiner assessment, fewer stimulation patients reported severe, marked, moderate, and no disability compared to the control group.

In the trial, serious adverse events (SAEs) occurred post-implantation in 9 patients, with 5 (4%) experiencing infections and 4 (3%) experiencing intracranial hemorrhage. Stimulation of the subthalamic nucleus was linked to dysarthria, fatigue, paraesthesias, and edema, while gait problems, disequilibrium, dyskinesia, and falls were reported in both the simulation and control groups.

In essential tremor, the DBS therapy was shown to improve quality of life after 1 year by a significant amount. According to Abbott (formerly St. Jude Medical), 98% of patients with essential tremor that were surveyed recommended the therapy to others.³

"Today's announcement of the newly released MRI-compatibility of the Infinity DBS system reflects Abbott's continued commitment to patient-centric, cutting-edge care—where the patient's options are expanded by the therapy instead of limited by it," said Brian Kopell, MD, a neurosurgeon and director of the Center for Neuromodulation at Mount Sinai Health System in New York City, in a statement.

REFERENCES

1. Abbott expands its directional deep brain stimulation therapy by offering new MR-conditional labeling [press release]. Abbott Park, IL: Abbott; August 2, 2018. abbott.mediaroom.com/2018-08-02-Abbott-Expands-its-Directional-Deep-Brain-Stimulation-Therapy-by-Offering-New-MR-Conditional-Labeling. Accessed August 2, 2018.

2. Okun MS, Gallo BV, Mandybur G, et al. Subthalamic deep brain stimulation with a constant-current device in Parkinson's disease: an open-label

randomised

controlled trial. Lancet Neurol. 2012;11(2):140-149.

doi

: 10.1016/S1474-4422(11)70308-8.

3. St. Jude Medical. (2014). Data on file, Tremor Study Final Report C-04-02, Table 24.