NCT05626608

Continuous Electrical Neuromodulation of the Globus Pallidus Intern in Parkinson's Disease by the Directional Electrode CARTESIA™

Neuromodulation électrique Continue du Globus Pallidus Dans la Maladie de Parkinson Par l'électrode Directionnelle CARTESIA™

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Many patients have benefited from the implantation of brain stimulation electrodes for the treatment of various motor signs of Parkinson's disease in the phase of motor fluctuations. This technique has significantly improved the motor symptomatology of Parkinson's disease and the dyskinesias induced by pharmacological treatment. Technological advances in the field of deep brain stimulation (DBS) could improve the benefit of this therapeutic tool. therapeutic tool. While using directional electrodes, it remains possible to program the stimulation in conventional ring mode.

Detailed description

Idiopathic Parkinson's disease represents the second degenerative disease after Alzheimer's disease, with progressive motor and non-motor symptoms, affecting the dopaminergic system (at the origin of the cardinal symptoms) and the other systems, cholinergic, noradrenergic and serotonergic (responsible for the dopa-resistant symptoms). The functional repercussions are important and a source of handicap in the more advanced phases of the disease. Many patients have benefited from the implantation of deep brain stimulation (DBS) electrodes, associated with dopaminergic replacement therapy, for the treatment of various motor signs of Parkinson's disease in the phase of motor fluctuations. It is an advanced symptomatic therapy that does not prevent the progression of the disease. DBS is intended for Parkinson's patients in the phase of motor fluctuations. The aim of this treatment is to complement the therapeutic effect of pharmacological treatments that patients will have to continue as well as to compensate for certain effects induced by the drugs. The effectiveness of DBS therapy may decrease over time, especially in the context of a progressive pathology, and requires a change of batteries after several years (4 to 15 years, depending on the type of neurostimulator, non-rechargeable or rechargeable). Beyond these constraints, this adaptable therapy has significantly improved the motor symptomatology of Parkinson's disease and the dyskinesias induced by pharmacological treatment. Technological advances in DBS could improve the therapeutic benefit of this technique and limit its side effects (dysarthria, hypophonia, oculomotor disorders, muscular contractions induced by the diffusion of the current), by using different modalities of brain stimulation. Implantation of Boston Scientific Cartesia™ directional electrodes for Parkinson's patients who are candidates for deep brain stimulation of the subthalamic nucleus (STN) would allow reorientation and variation of the volume of the stimulated structure, which could improve therapeutic performance, by stimulating key target volumes for obtaining the clinical effect, limiting side effects by diffusion of the current on neighboring structures. While using directional electrodes, it remains possible to program the stimulation in ring mode, conventional stimulation modality, in monopolar or bipolar. The hypothesis is that the efficacy of DBS in directional mode will be more effective on the motor signs of Parkinson's disease compared to omnidirectional stimulation and bipolar mode, with a better tolerance profile (fewer side effects).

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	Classical ring stimulation	Unilateral or bilateral subthalamic nucleus stimulation in the treatment of Parkinson's disease using Boston Cartesia(TM) electrodes
DEVICE	Stimulation in directional mode	Directional stimulation of the subthalamic nucleus in the treatment of Parkinson's disease using Boston Cartesia(TM) electrodes

Timeline

• Start date: 2023-04-28
• Primary completion: 2026-10-28
• Completion: 2026-10-28
• First posted: 2022-11-25
• Last updated: 2025-11-28

Locations

1 site across 1 country: France