TY - JOUR
T1 - Directional Deep Brain Stimulation for Parkinson's Disease
T2 - Results of an International Crossover Study With Randomized, Double-Blind Primary Endpoint
AU - PROGRESS Study Investigators
AU - Schnitzler, Alfons
AU - Mir, Pablo
AU - Brodsky, Matthew A.
AU - Verhagen, Leonard
AU - Groppa, Sergiu
AU - Alvarez, Ramiro
AU - Evans, Andrew
AU - Blazquez, Marta
AU - Nagel, Sean
AU - Pilitsis, Julie G.
AU - Pötter-Nerger, Monika
AU - Tse, Winona
AU - Almeida, Leonardo
AU - Tomycz, Nestor
AU - Jimenez-Shahed, Joohi
AU - Libionka, Witold
AU - Carrillo, Fatima
AU - Hartmann, Christian J.
AU - Groiss, Stefan Jun
AU - Glaser, Martin
AU - Defresne, Florence
AU - Karst, Edward
AU - Cheeran, Binith
AU - Vesper, Jan
N1 - Publisher Copyright:
© 2022
PY - 2022
Y1 - 2022
N2 - 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.
AB - 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.
KW - Deep brain stimulation
KW - Parkinson's disease
KW - directional programming
KW - therapeutic window
UR - http://www.scopus.com/inward/record.url?scp=85106942140&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85106942140&partnerID=8YFLogxK
U2 - 10.1111/ner.13407
DO - 10.1111/ner.13407
M3 - Article
C2 - 34047410
AN - SCOPUS:85106942140
SN - 1094-7159
JO - Neuromodulation
JF - Neuromodulation
ER -