RT Journal Article T1 Directional Deep Brain Stimulation for Parkinson's Disease: Results of an International Crossover Study With Randomized, Double-Blind Primary Endpoint. A1 Schnitzler, Alfons A1 Mir, Pablo A1 Brodsky, Matthew A A1 Verhagen, Leonard A1 Groppa, Sergiu A1 Alvarez, Ramiro A1 Evans, Andrew A1 Blazquez, Marta A1 Nagel, Sean A1 Pilitsis, Julie G A1 Pötter-Nerger, Monika A1 Tse, Winona A1 Almeida, Leonardo A1 Tomycz, Nestor A1 Jimenez-Shahed, Joohi A1 Libionka, Witold A1 Carrillo, Fatima A1 Hartmann, Christian J A1 Groiss, Stefan Jun A1 Glaser, Martin A1 Defresne, Florence A1 Karst, Edward A1 Cheeran, Binith A1 Vesper, Jan A1 PROGRESS Study Investigators, K1 Deep brain stimulation K1 Parkinson's disease K1 directional programming K1 therapeutic window AB Published reports on directional deep brain stimulation (DBS) have been limited to small, single-center investigations. Therapeutic window (TW) is used to describe the range of stimulation amplitudes achieving symptom relief without side effects. This crossover study performed a randomized double-blind assessment of TW for directional and omnidirectional DBS in a large cohort of patients implanted with a DBS system in the subthalamic nucleus for Parkinson's disease. Participants received omnidirectional stimulation for the first three months after initial study programming, followed by directional DBS for the following three months. The primary endpoint was a double-blind, randomized evaluation of TW for directional vs omnidirectional stimulation at three months after initial study programming. Additional data recorded at three- and six-month follow-ups included stimulation preference, therapeutic current strength, Unified Parkinson's Disease Rating Scale (UPDRS) part III motor score, and quality of life. The study enrolled 234 subjects (62 ± 8 years, 33% female). TW was wider using directional stimulation in 183 of 202 subjects (90.6%). The mean increase in TW with directional stimulation was 41% (2.98 ± 1.38 mA, compared to 2.11 ± 1.33 mA for omnidirectional). UPDRS part III motor score on medication improved 42.4% at three months (after three months of omnidirectional stimulation) and 43.3% at six months (after three months of directional stimulation) with stimulation on, compared to stimulation off. After six months, 52.8% of subjects blinded to stimulation type (102/193) preferred the period with directional stimulation, and 25.9% (50/193) preferred the omnidirectional period. The directional period was preferred by 58.5% of clinicians (113/193) vs 21.2% (41/193) who preferred the omnidirectional period. Directional stimulation yielded a wider TW compared to omnidirectional stimulation and was preferred by blinded subjects and clinicians. YR 2022 FD 2022-02-02 LK http://hdl.handle.net/10668/17847 UL http://hdl.handle.net/10668/17847 LA en DS RISalud RD Apr 6, 2025