Alfons Schnitzler1, Pablo Mir2, Matthew A Brodsky3, Leonard Verhagen4, Sergiu Groppa5, Ramiro Alvarez6, Andrew Evans7, Marta Blazquez8, Sean Nagel9, Julie G Pilitsis10, Monika Pötter-Nerger11, Winona Tse12, Leonardo Almeida13, Nestor Tomycz14, Joohi Jimenez-Shahed10, Witold Libionka15, Fatima Carrillo16, Christian J Hartmann17, Stefan Jun Groiss17, Martin Glaser18, Florence Defresne19, Edward Karst19, Binith Cheeran19, Jan Vesper20. 1. Department of Neurology, Heinrich Heine University of Düsseldorf, Düsseldorf, Germany. Electronic address: schnitza@med.uni-duesseldorf.de. 2. Clinical Neurology and Neurophysiology Department, Movement Disorders Unit, Institute of Biomedicine of Seville, Virgen del Rocío University Hospital, CSIC/University of Seville, Seville, Spain; Network Center for Biomedical Research in Neurodegenerative Diseases (CIBERNED), Seville, Spain. 3. Department of Neurology, Oregon Health and Science University, Portland, OR, USA. 4. Department of Neurological Sciences, Rush University, Chicago, IL, USA. 5. Johannes Gutenberg University of Mainz, Clinic of Neurology, Mainz, Germany. 6. Department of Neurology, Hospital Trias i Pujol, Badalona, Spain. 7. Department of Neurology, Royal Melbourne Hospital, Melbourne, Australia. 8. Department of Neurology, Hospital Universitario Central de Asturias, Spain. 9. Department of Neurosurgery, Cleveland Clinic Foundation, Cleveland, OH, USA. 10. Department of Neurosurgery, Albany Medical Center, New York, NY, USA. 11. Department of Neurology, University Medical Centre Hamburg, Hamburg, Germany. 12. Department of Neurology, Mount Sinai Hospital, New York, NY, USA. 13. Department of Neurology, Shands at University of Florida, Gainesville, FL, USA. 14. Department of Neurosurgery, Allegheny General Hospital, Pittsburgh, PA, USA. 15. Department of Neurology, Copernicus Hospital, Gdansk, Poland. 16. Clinical Neurology and Neurophysiology Department, Movement Disorders Unit, Institute of Biomedicine of Seville, Virgen del Rocío University Hospital, CSIC/University of Seville, Seville, Spain. 17. Department of Neurology, Heinrich Heine University of Düsseldorf, Düsseldorf, Germany. 18. Department of Neurosurgery, Johannes Gutenberg University of Mainz, Mainz, Germany. 19. Abbott, Medical and Clinical Affairs, Plano, TX, USA. 20. Department of Neurosurgery, Heinrich Heine University of Düsseldorf, Düsseldorf, Germany.
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.
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.
Authors: Maija Koivu; Filip Scheperjans; Johanna Eerola-Rautio; Nuutti Vartiainen; Julio Resendiz-Nieves; Riku Kivisaari; Eero Pekkonen Journal: J Pers Med Date: 2022-07-27