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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• A diagnosis of bilateral idiopathic Parkinson's disease according to the British Brain Bank criteria (bradykinesia and rigidity or resting tremor)

• Parkinson's disease that has been evolving for several years (\>4 years)

• Persistence of a good sensitivity to L-Dopa, essential criterion in the selection, except for tremor (Improvement in Parkinson's disease symptoms of at least 30% measured on the UPDRS, section III)

• A UPDRS (Unified Parkinson Disease Rating Scale) part III motor score \>25 under MEDOFF conditions

• Patient with tremor not controlled́ by treatment and which represents the bulk of the symptomatology. Patient will require stable treatment throughout the study.

• Patient with major motor fluctuations with prolonged blocking and/or dyskinesias

• Be a candidate for PCS and bilateral electrode implantation in the STN.

• A Hoehn and Yahr scale score ≤ 2.5 under best MED-ON conditions

• A UPDRS section II activities of daily living score \> 6

• Patient without comorbidities that do not allow the patient to undergo general anesthesia general anesthesia or a neurosurgical procedure or interfering with the follow-up required by the protocol

Locations
Other Locations
France
Centre Hospitalier Uniersitaire de Montpellier
RECRUITING
Montpellier
Contact Information
Primary
Laura CIF, PD
a-cif@chu-montpellier.fr
0467337262
Backup
Gaëtan POULEN, PD
g-poulen@chu-montpellier.fr
0467337262
Time Frame
Start Date: 2023-04-28
Estimated Completion Date: 2026-10
Participants
Target number of participants: 10
Treatments
Experimental: Directional
Directional stimulation of the subthalamic nucleus in the treatment of Parkinson's disease using Boston Cartesia(TM) electrodes
Active_comparator: Conventional ring (Monopolar and Bipolar)
Unilateral or bilateral subthalamic nucleus stimulation in the treatment of Parkinson's disease using Boston Cartesia(TM) electrodes
Sponsors
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov