Directional Deep Brain Stimulation for Parkinson's Disease: Results of an International Crossover Study With Randomized, Double-Blind Primary Endpoint
Alfons Schnitzler, Pablo Mir, Matthew A Brodsky, Leonard Verhagen, Sergiu Groppa, Ramiro Alvarez, Andrew Evans, Marta Blazquez, Sean Nagel, Julie G Pilitsis, Monika Pötter-Nerger, Winona Tse, Leonardo Almeida, Nestor Tomycz, Joohi Jimenez-Shahed, Witold Libionka, Fatima Carrillo, Christian J Hartmann, Stefan Jun Groiss, Martin Glaser, Florence Defresne, Edward Karst, Binith Cheeran, Jan Vesper, PROGRESS Study Investigators, Alfons Schnitzler, Jan Vesper, Pablo Mir, Leonardo Verhagen, Nestor Tomcyz, Christian J Hartmann, Sergiu Groppa, Ramiro Alvarez, Julie Pilitsis, Monika Pötter-Nerger, Stefan Jun Groiss, Matthew A Brodsky, Alfons Schnitzler, Pablo Mir, Matthew A Brodsky, Leonard Verhagen, Sergiu Groppa, Ramiro Alvarez, Andrew Evans, Marta Blazquez, Sean Nagel, Julie G Pilitsis, Monika Pötter-Nerger, Winona Tse, Leonardo Almeida, Nestor Tomycz, Joohi Jimenez-Shahed, Witold Libionka, Fatima Carrillo, Christian J Hartmann, Stefan Jun Groiss, Martin Glaser, Florence Defresne, Edward Karst, Binith Cheeran, Jan Vesper, PROGRESS Study Investigators, Alfons Schnitzler, Jan Vesper, Pablo Mir, Leonardo Verhagen, Nestor Tomcyz, Christian J Hartmann, Sergiu Groppa, Ramiro Alvarez, Julie Pilitsis, Monika Pötter-Nerger, Stefan Jun Groiss, Matthew A Brodsky
Abstract
Objective: 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.
Materials and methods: 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.
Results: 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.
Conclusion: Directional stimulation yielded a wider TW compared to omnidirectional stimulation and was preferred by blinded subjects and clinicians.
Keywords: Deep brain stimulation; Parkinson's disease; directional programming; therapeutic window.
Copyright © 2022. Published by Elsevier Inc.
Source: PubMed