Personalized, adaptive deep brain stimulation (aDBS) is safe and effective for controlling motor symptoms over 10 months in adults with Parkinson’s disease (PD), new research showed.

The ADAPT-PD trial used Medtronic’s BrainSense aDBS system which automatically adjusts stimulation amplitude in response to changes in relevant brain activity in patients with PD.

As previously reported by Medscape Medical News, the FDA approved the system last February, making it the first device of its kind authorized for clinical use in PD.

The approval was based on a small pilot study, which suggested that aDBS could enhance control of PD motor symptoms compared with standard continuous DBS.

Led by Helen Bronte-Stewart, MD, MSE, director of the Stanford University Movement Disorders Center in Palo Alto, California, the ADAPT-PD trial evaluated the safety and efficacy of long-term aDBS delivered at home.

The results were published online on September 22 in JAMA Neurology.

Improved On-Time 

The international, nonrandomized, open-label trial enrolled patients with moderate-to-advanced PD previously implanted with bilateral DBS leads and who were stable on continuous DBS and medication at baseline.

Of 52 patients who underwent a 1- to 2-month setup and adjustment phase, seven were excluded, leaving 45 who entered the aDBS crossover evaluation phase: 30 days on single-threshold (ST-aDBS) and 30 days on dual-threshold (DT-aDBS). Fifteen patients tolerated only one mode and were evaluated in that mode only (10 received DT-aDBS and five received ST-aDBS).

Following the crossover evaluation period, patients could choose whether to continue with aDBS or return to standard continuous DBS for the 10-month follow-up period.

The prespecified primary outcome was met as 95% of patients receiving DT-aDBS and 87% of those receiving ST-aDBS had on-time without troublesome dyskinesia comparable to continuous DBS.

The primary endpoint for the post hoc analysis was also met as 91% of patients receiving DT-aDBS and 79% receiving ST-aDBS had on-time without troublesome dyskinesia on par with continuous DBS.

Exploratory analyses suggested that DT-aDBS improved on-time without troublesome dyskinesias by 1.3 hours per day and reduced off-time by 1.6 hours per day compared with standard continuous DBS.

All but one patient (44/45) opted to continue receiving aDBS for the 10-month follow-up period, citing improved motor control (63%), fewer symptom fluctuations (66%), or reduced side effects (45%). Forty of 44 patients chose to continue receiving aDBS into the extended access phase (more than 1 year of aDBS).

A secondary endpoint focused on energy efficiency also favored aDBS.

Total electrical energy delivered was reduced by 15% with ST-aDBS compared with continuous DBS, and no different from DT-aDBS. Over time, this could translate into longer battery life for implantable devices, the researchers noted.

Safety outcomes were reassuring. Stimulation-related adverse events were mostly limited to transient worsening of PD symptoms during the setup phase, as would be expected when optimizing DBS settings. Nearly all resolved with reprogramming, and no serious device-related complications were reported.

“Delivering adaptive neurostimulation chronically, in response to a personalized neural physiomarker, is both technically and clinically possible, laying the foundation for the wider clinical application of aDBS,” the authors wrote.

“Adaptive deep brain stimulation will help revolutionize the approach to therapeutic treatment for patients with Parkinson’s disease,” Bronte-Stewart said in a Medtronic news release announcing approval of the device earlier this year.

“The transformative personalized care we can achieve through automatic adjustment greatly benefits patients receiving therapy that adapts to their evolving needs,” Bronte-Stewart added.

The ADAPT-PD trial was funded by Medtronic. Medtronic was involved in the design and conduct of the study, collection, management, and analysis of the study data. Medtronic relied on study investigators and members of the ADAPT-PD Publication Committee for interpretation of the data. All investigators and their institutions received sponsorship for the conduct of the ADAPT-PD clinical trial from Medtronic.