Objective: In this randomized controlled clinical trial, we aim to characterize the differential effect of subthalamic nucleus (STN) or subthalamic nucleus and substantia nigra pars reticulata (STN+SNr) deep brain stimulation (DBS) on dysphagia in Parkinson’s disease (PD) as primary interest.

Background: Dysphagia is a frequent and threatening symptom in late-stage PD and highly associates with mortality and quality of life. It represents an urgent unaddressed therapeutic need as conventional treatments (dopaminergic medication, STN-DBS) have limited effect on dysphagia. Attempts have been made to modulate non-dopaminergic pathways for resistant symptoms in PD[1]. As such, the SNr may modulate brainstem activity via its monosynaptic projections to the superior colliculus (SC) and the peduncolopontine nucleus (PPN). There is evidence that swallowing associates to neuronal integration upon the SNr-SC pathway[2].

Methods: In this double-blind randomized controlled study, we aim to investigate 20 patients with idiopathic PD with disease duration of ≥ 5 years, DBS ≥ 6 months and clinical dysphagia with a penetration-aspiration scale (PAS) ≥ 3. First, we test the effect of StimOff, STNmono, and SNrmono on swallowing. The active treatment starts with a baseline assessment. Then, we will randomize patients to either ‘standard-STN’ or ‘STN+SNr’ for eight weeks. The primary endpoint hypothesizes on a two-point improvement on the PAS. [figure1] A sample size of 10 per group will have 81% power to reject the null hypothesis (H0: p=0.5 vs H1: p≤0.17) that an observation in Experimental Group (STN+SNr) is less than in Standard Group (standard-STN) (p<0,05).

Results: The clinical trial is currently active and recruiting.

Conclusions: We expect results in 2020.

References: [1] Weiss D, Walach M, Meisner C, Fritz M, Scholten M, Breit S, et al. Nigral stimulation for resistant axial motor impairment in Parkinson’s disease? A randomized controlled trial. Brain. 2013. [2] Rossi MA, Li HE, Lu D, Kim IH, Bartholomew RA, Gaidis E, et al. A GABAergic nigrotectal pathway for coordination of drinking behavior. Nat Neurosci. 2016.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/clinical-trial-protocol-restitution-of-oral-transport-penetration-and-aspiration-with-nigral-stimulation-in-parkinsons-disease/