Objective: To evaluate the efficacy of directional Deep Brain Stimulation (DBS) by assessing the therapeutic window for directional versus omnidirectional stimulation.

Background: Directional leads for DBS have four ring electrodes, with the two middle rings divided into three segments. The Infinity DBS system (Abbott) delivers conventional omnidirectional stimulation to all three segments of the ring, or directional stimulation to only one or two segments. PROGRESS is the first large, prospective, multi‑center study conducted to evaluate safety and clinical performance of directional DBS.

Method: Directional and omnidirectional stimulation were compared in 66 subjects receiving DBS in the subthalamic nucleus for Parkinson’s disease. The primary endpoint was the difference in therapeutic window for directional vs. omnidirectional stimulation assessed by a blinded reviewer at the 3-month follow-up visit. Subjects were programmed with omnidirectional stimulation for 3 months, followed by directional for 3 months and blinded to stimulation type for the first 6 months. Additional endpoints included subject and clinician preference at 6 months after receiving both omnidirectional and directional stimulation, therapeutic current strength and UPDRS part III motor score.

Results: The primary endpoint was evaluated in 66 subjects (32% female, 63±9 years). There was a wider TW for directional stimulation in 59 of 66 subjects (89.4%), compared to just 3 of 66 subjects (4.5%) who had wider TW on both leads with omnidirectional stimulation. Single-segment activation produced wider TW than omnidirectional stimulation in 56 of 66 subjects (84.8%). Mean TW was 35% wider with directional stimulation (3.00±1.39 mA vs. 2.22±1.27 mA), and therapeutic current strength was reduced by 30% using the optimal directional configuration. UPDRS part III motor score off medication was reduced by 39.4% with stimulation at the 3-month visit and 40.6% at the 6-month visit (p<0.001 for both comparisons). Over 4 times as many clinicians and 2 times as many subjects preferred the period using directional stimulation.

Conclusion: PROGRESS met the primary endpoint for superiority, with 89.4% of subjects (59 of 66) having a wider TW using directional DBS stimulation. This international prospective blinded crossover study is the largest clinical study of directional DBS to date.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/directional-versus-omnidirectional-deep-brain-stimulation-for-parkinsons-disease-results-of-a-prospective-blinded-multi%e2%80%91center-single-arm-crossover-study/