Objective: To assess the safety and efficacy of chronic adaptive (aDBS) and conventional (cDBS) deep brain stimulation of the subthalamic nucleus in patients with Parkinson’s disease (PD).

Background: aDBS is becoming a real therapeutic option for patients implanted with DBS systems and implantable devices are now available to assess its therapeutic potential.

Method: Fifteen patients were implanted with the AlphaDBS® device (Newronika SpA, Milan, Italy, NCT04681534). In 11 patients the device replaced at battery depletion a previous Medtronic ActivaPC, while in the other 4 patients the device was implanted for the first time. Patients underwent two study phases, a short-term follow up (ST-FUP) consisting of a 2-days experimental session in the hospital in which the patient received aDBS and cDBS for one day each (in random order), and a one-month long-term follow-up phase (LT-FUP), with the patient at home treated for 2 weeks in each DBS mode. UPDRS-III and UDysRS scales were used for in-clinic assessment, while a 3-days diary (Hauser diary) was used for the home assessment to estimate the good on time (ON time without troublesome dyskinesia). At the end of the study, patients blindly decided their preferred DBS mode and continued the DBS treatment. Data are reported as mean±SD.

Results: No aDBS related adverse events were reported. The system reliably recorded deep brain signals, and adjusted DBS parameters using the linear adaptive DBS algorithm.

In the ST-FUP, patients showed better UdysRS scores with aDBS vs. cDBS (7.3±7.9 vs. 4.9±5.9[MOU1] ) and comparable UPDRS-III scores (UPDRS-III % improvement MedOFF/StimOFF to MedOFF/StimON cDBS vs. aDBS: 0.56±0.16 vs. 0.54±0.18; MedOFF/StimOFF to MedON/StimON: 0.66±0.14 vs. 0.61±0.16).

In the LT-FUP, both DBS modes resulted in a high percentage of GOT (aDBS: 12.02 hours ±5.62, 80% of awake time and cDBS: 11.24 hours ±4.12, 72% of awake time).

Although patients were blinded for the type of stimulation, they were aware of receiving two different DBS modalities and 90% of them preferred and continued with aDBS.

Conclusion: The aDBS appears to be safe and reliable. These preliminary results suggest that although improvements in UPDRS-III and GOT are similar, most PD patients preferred aDBS to cDBS, implying the need to define reliable measures reflecting the patient’s perceived efficacy.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/adaptive-vs-conventional-chronic-deep-brain-stimulation-results-from-a-randomized-pilot-trial-in-parkinsons-disease/