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New treatment option for Parkinson Disease
Official title Continuous Electrical Neuromodulation of the Globus Pallidus Intern in Parkinson's Disease by the Directional Electrode CARTESIA™
ClinicalTrials.gov ID: NCT05626608
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join 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...
- 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...
You likely can't join if
- Characterized depressive episode (BDI\>25) (depressive episodes prior to inclusion and completed at the time of inclusion will not be considered as a...
- Psychotic episodes (Brief Psychiatric Rating Scale, BPRS) (mild hallucinations or acute psychotic episodes preceding the screening and inclusion...
- Dementia (Mattis DRS score \<125)
- Contraindication to general anesthesia
- Absolute MRI contraindications: Pacemaker or neurosensory stimulator or implantable defibrillator; Cochlear implants; Ocular or cerebral...
- Relative MRI contraindications: Metallic prostheses, especially orthodontic braces; Patient agitation; Pregnant women; Ventriculoperitoneal...
See the full eligibility criteria
- 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
- 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...
- 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...
- Impossibility or refusal of regular follow-up of at least 30 months
- Participation in other treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Montpellier, France, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montpellier, France, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.