NCT03470324

Combined Stimulation of STN and SNr for Dysphagia in Parkinson's Disease

Combined Stimulation of Subthalamic Nucleus and Substantia Nigra Pars Reticulata for Dysphagia: A Randomized Controlled Multicenter Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

20 patients with idiopathic Parkinson's disease and dysphagia will be included into this randomised controlled double-blinded parallel group clinical trial. The treatment consists of two different stimulation settings using (i) conventional stimulation of the subthalamic nucleus \[standard STN\] as active comparator and (ii) combined stimulation of active electrode contacts located in both the subthalamic nucleus and substantia nigra pars reticulata \[STN+SNr\]. Both groups receive additional swallowing therapy as standard of care.

Detailed description

The primary endpoint of this study is to investigate the efficacy and safety of combined \[STN+SNr\] stimulation by "interleaving stimulation" as compared to \[standardSTN\] after 8 weeks on dysphagia. The Trial is designed as superiority study with an 81% power to detect a clinically relevant mean improvement of 2 points on the Penetration Aspiration Scale for fluids (two-tailed p \< 0.05). To this end 20 patients will be randomized. After a common baseline assessment in \[standardSTN\], patients will be randomized to either \[standardSTN\] or \[STN+SNr\] in 1:1 ratio (10 per arm). The primary endpoint assessment is scheduled 8 weeks from baseline assessment (V2). Both treatment arms will receive swallowing therapy as standard of care. The rationale for this study comes from the association of swallowing and oral transport to neuronal integration upon the substantial nigra pars reticulate (SNr)-superior colliculus (SC) pathway (Rossi et al., 2016). Deep brain stimulation of the SNr has been put forward to modulate brainstem circuitry through its monosynaptic brainstem projections to the SC and to the pedunculopontine nucleus (PPN) (Chastan et al., 2009, Weiss et al., 2013, Rossi et al., 2016). Secondary outcome measures include anamnestic assessments on dysphagia, clinical global impression, freezing of gait and falls, balance, quality of life, neuropsychiatric symptoms and suicidality. Secondary outcome measures also include clinical assessment of dysphagia (Site of Swallow Reflex Initiation, Test of Mastication and Swallowing solids, pharyngeal residue) as well as motor symptoms with MDS-UPDRS III, Capsit-PD and Freezing of Gait Assessment Course.

Conditions

• Parkinson's Disease
• Dysphagia

Interventions

Type	Name	Description
DEVICE	[standard STN]	standard stimulation on subthalamic (STN) contacts High frequency deep brain stimulation with variable (best individual) stimulation on subthalamic contacts
DEVICE	[STN+SNr]	Combined stimulation of the subthalamic nucleus (STN) and the substantia nigra pars reticulata (SNr) high frequency deep brain stimulation of combined (best individual) subthalamic and nigral stimulation
BEHAVIORAL	Swallowing therapy	Swallowing therapy with speech therapist

Timeline

• Start date: 2018-04-27
• Primary completion: 2020-05-01
• Completion: 2020-07-01
• First posted: 2018-03-19
• Last updated: 2018-05-30

Locations

1 site across 1 country: Germany