Actively Recruiting
Continuous Electrical Neuromodulation of the Globus Pallidus Intern in Parkinson's Disease by the Directional Electrode CARTESIA™
Led by University Hospital, Montpellier · Updated on 2025-11-28
10
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Continuous Electrical Neuromodulation of the Globus Pallidus Intern in Parkinson's Disease by the Directional Electrode CARTESIA™
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of bilateral idiopathic Parkinson's disease according to the British Brain Bank criteria (bradykinesia and rigidity or resting tremor)
- Parkinson's disease duration longer than 4 years
- Good response to L-Dopa with at least 30% improvement in symptoms except for tremor
- UPDRS part III motor score greater than 25 under MEDOFF conditions
- Tremor not controlled by treatment representing main symptom, with stable treatment during study
- Presence of major motor fluctuations with prolonged blocking and/or dyskinesias
- Candidate for pallidal continuous stimulation and bilateral electrode implantation in the subthalamic nucleus
- Hoehn and Yahr scale score of 2.5 or less under best MED-ON conditions
- UPDRS section II activities of daily living score greater than 6
- No comorbidities preventing general anesthesia or neurosurgical procedure or interfering with study follow-up
You will not qualify if you...
- Characterized depressive episode with BDI score above 25, except past resolved episodes
- Psychotic episodes as per Brief Psychiatric Rating Scale, except past resolved episodes
- Dementia with Mattis Dementia Rating Scale score below 125
- Contraindication to general anesthesia
- Absolute MRI contraindications such as pacemaker, implantable defibrillator, cochlear implants, or ferromagnetic foreign bodies near nerves
- Relative MRI contraindications including metallic prostheses, patient agitation, pregnancy, neurosurgical shunt valves, or tattoos with iron particles
- Abnormal cerebral MRI findings like stroke aftermath, vascular malformations, or major cerebral atrophy
- Serious intercurrent illness or surgical contraindications
- Pregnancy, breastfeeding, or women of childbearing potential without effective contraception
- Inability or refusal for regular follow-up of at least 30 months
- Participation in other interventional research
- Adult protected by law or under guardianship
- Inability to use or receive assistance with the remote control and charging system
- Failure to provide informed consent after reflection period
- Not affiliated with French social security system or beneficiary status
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centre Hospitalier Uniersitaire de Montpellier
Montpellier, France, France, 34295
Actively Recruiting
Research Team
G
Gaëtan POULEN, PD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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