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.
| Original language | English (US) |
|---|---|
| Journal | Neuromodulation |
| DOIs | |
| State | Accepted/In press - 2022 |
Funding
Alfons Schnitzler, Jan Vesper, Pablo Mir, Leonardo Verhagen, and Matthew A. Brodsky are members of the PROGRESS Steering Committee. 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, and Matthew A. Brodsky received compensation for professional services from Abbott. Alfons Schnitzler and Jan Vesper received speaker honoraria from Abbott. Florence Defresne, Edward Karst, and Binith Cheeran are employees of Abbott. Joohi Jimenez‐Shahed received research support from Medtronic and Abbott, consulting fees from Medtronic and Boston Scientific, honoraria for lectures from Abbott and has served on an advisory board for the ADROIT registry with Abbott. Sean Nagel has received consulting fees from Abbott and honoraria for lectures from Medtronic. Sergiu Groppa has received honoraria for lectures from Abbvie, UCB, and Abbott. Dr. Groppa has also participated as an Adjucations Committee Member for Abbott and received IIT grants from Abbott, MagVenture, and Boston Scientific. Alfons Schnitzler has received grants from the German Research Council, Abbott, Medtronic, and Boston Scientific. Dr. Schnitzler has also received consulting fees from Abbott, Medtronic, Boston Scientific, and Zambon. Dr. Schnitzler has received payment or honoraria from Abbott, Medtronic, Boston Scientific, Abbvie, dPV, and BIAL. Leonardo Almeida has received consulting fees from Medtronic, Boston Scientific; honoraria for lectures from Medtronic, Boston Scientific, and the Movement Disorders Society. Nestor Tomycz has received a grant for DBS for opioid use disorder and consulting fees from Abbott. Monika Pötter‐Nerger has received governmental grants from DFG; consulting fees from Abbvie, Abbott, Medtronic, Boston Scientific, Licher, and Zambon. Dr. Pötter‐Nerger has also received speaker honoraria from Abbvie and Abbott, travel support and participation as an advisory board member from Abbvie. Christian Hartmann has received grant support from Abbott and lecture honoraria from BSH medical communications (sponsored by Abbott). Pablo Mir has received honorarium for lecturing from Abbott, Allergan, Abbvie, Bial, Britannia, Italfarmaco, Merz, UCB, Teva, Zambon and has received support for attending meetings and/or travel from Abbott, Abbvie, Bial, Teva, and Zambon. Dr. Carrillo has received honorarium for lecturing from Abbvie, Bial, Teva, and Zambon and has received support for attending meetings and/or travel from Abbott and Abbvie. Dr. Pilitsis reports grants and other from Boston Scientific, grants and other from Nevro, grants and other from Abbott, grants and other from Medtronic, other from Saluda, grants and other from TeSera, grants from NIH 2R01CA166379–06, grants from NIH U44NS115111, other from Aim Medical Robotics, other from Karuna Labs, outside the submitted work. The remaining authors have no conflicts of interest to disclose. Conflict of Interest:
Keywords
- Deep brain stimulation
- Parkinson's disease
- directional programming
- therapeutic window
ASJC Scopus subject areas
- Neurology
- Clinical Neurology
- Anesthesiology and Pain Medicine