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

Recruiting now · Not applicable

Conditions studied: Parkinson Disease

In brief

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.

Key facts

Study ID

NCT05626608

Run by

University Hospital, Montpellier

People needed

10

Starts

2023-04-28

Expected to finish

2026-10-28

Last updated by the study team

2025-11-28

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Characterized depressive episode (BDI>25) (depressive episodes prior to inclusion and completed at the time of inclusion will not be considered as a non-inclusion criterion)
• Psychotic episodes (Brief Psychiatric Rating Scale, BPRS) (mild hallucinations or acute psychotic episodes preceding the screening and inclusion period and completed at the time of inclusion will not be considered as non-inclusion criteria)
• Dementia (Mattis DRS score <125)
• Contraindication to general anesthesia
• Absolute MRI contraindications: Pacemaker or neurosensory stimulator or implantable defibrillator; Cochlear implants; Ocular or cerebral ferromagnetic foreign bodies close to nerve structures
• Relative MRI contraindications: Metallic prostheses, especially orthodontic braces; Patient agitation; Pregnant women; Ventriculoperitoneal neurosurgical shunt valves; Tattoos containing iron particles
• Contraindication revealed by abnormal cerebral MRI (after-effects of stroke, vascular malformations, major cerebral atrophy)
• Serious intercurrent pathology
• Surgical contraindication
• Pregnancy in progress or planned during the study period, Pregnant or breastfeeding women or women in a state of procreation without contraception Women who are pregnant or breastfeeding or in a state of procreation without effective contraception
• Impossibility or refusal of regular follow-up of at least 30 months
• Participation in other interventional research
• Adult protected by law or patient under guardianship or curatorship
• Patient unable to use the remote control and charging system properly or who does not have a person who can assist them in this process
• Failure to obtain written informed consent after a period of reflection
• Not being affiliated to a French social security system or being a beneficiary of such a system

Where it is running

• Centre Hospitalier Uniersitaire de Montpellier — Montpellier, France, France (enrolling)

Full record on ClinicalTrials.gov

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