Electrical stimulation of the brain to treat Parkinson's disease
Neuromodulation électrique Continue du Globus Pallidus Dans la Maladie de Parkinson Par l'électrode Directionnelle CARTESIA™
This study tests if a new way of using electrical stimulation in the brain can help people with Parkinson's disease manage their movement problems better while they keep taking their regular medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier, France) |
| Trial ID | NCT05626608 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of continuous electrical neuromodulation in the globus pallidus intern for patients with Parkinson's disease. It employs directional electrodes to enhance the effectiveness of deep brain stimulation (DBS) in managing motor symptoms and fluctuations associated with the condition. The approach aims to improve patient outcomes by optimizing stimulation patterns while patients continue their pharmacological treatments. The study focuses on patients who have experienced significant motor fluctuations and are candidates for bilateral electrode implantation.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with bilateral idiopathic Parkinson's disease who have had the condition for over four years and experience significant motor fluctuations.
Not a fit: Patients with Parkinson's disease who do not experience motor fluctuations or have not responded well to L-Dopa may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve motor symptoms and reduce dyskinesias in patients with Parkinson's disease.
How similar studies have performed: Other studies utilizing deep brain stimulation techniques have shown success in improving motor symptoms in Parkinson's disease, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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 this trial is running
Montpellier, France
- Centre Hospitalier Uniersitaire de Montpellier — Montpellier, France, France (Recruiting)
Study contacts
- Study coordinator: Gaëtan POULEN, PD
- Email: g-poulen@chu-montpellier.fr
- Phone: 0467337262
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.