Objective: This monocentric, randomised, blind study is designed to evaluate the effect of safinamide on motor and neuropsychiatric symptoms in the 3 month perioperative period in parkinsonian patients (PD) after deep brain stimulation in the subthalamic nucleus (STN-DBS).
Background: The early perioperative period with STN-DBS might be complicated by residual motor fluctuations or neuropsychiatric symptoms as apathy and depression. To date it is unclear whether safinamide might be beneficial in the acute postoperative period to stabilize and improve motor and neuropsychiatric symptoms through its dual dopaminergic and antiglutamatergic mechanisms.
Method: This monocentric, blind study aims to assess 35 PD patients with implanted STN-DBS which are randomised either to the group of immediate restart of safinamide (first week 50mg, second week 100mg) after STN-DBS surgery or without safinamide in the first three months of the postoperative period. Clinical motor and neuropsychiatric outcome before and 3 months after DBS surgery are compared. Preliminary results (mean ± standard deviation) as difference of postoperative-preoperative scores in the on-medication state were compared by Mann Whitney U test.
Results: Preliminary results of 25 patients (mean age 61.12 ± 6.98; 16 males) reveal improved balance (Berg balance score, -0.38 ± 3.93 vs. 1.90 ± 3.11, p=0.148) and freezing of gait (FOG Ziegler score, -0.85 ± 2.04 vs. 0.11 ± 0.33, p=0.235).The safinamide cohort had a slightly less, but not significantly different cognitive decline (MoCA, 0.20 ± 2.20 vs. -0.63 ± 1.92, p=0.460) and less fatigue (MFIS,-13.67 ± 20.67 vs. -2.55 ± 12.60, p=0.134).
Conclusion: These first results indicate a non-significant trend towards greater motor and certain neuropsychiatric symptom reduction of safinamide in the perioperative period.
To cite this abstract in AMA style:
E. Gülke, M. Höfs, H. Pinnschmidt, A. Gulberti, C. Moll, U. Hidding, C. Buhmann, M. Heise, W. Hamel, M. Pötter-Nerger. SAFE-DBS – A monocentric, randomised, blind evaluation of safinamide in the perioperative period in Parkinsonian patients with deep brain stimulation [abstract]. Mov Disord. 2023; 38 (suppl 1). https://www.mdsabstracts.org/abstract/safe-dbs-a-monocentric-randomised-blind-evaluation-of-safinamide-in-the-perioperative-period-in-parkinsonian-patients-with-deep-brain-stimulation/. Accessed June 15, 2025.« Back to 2023 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/safe-dbs-a-monocentric-randomised-blind-evaluation-of-safinamide-in-the-perioperative-period-in-parkinsonian-patients-with-deep-brain-stimulation/