Parkinson DiseaseNEC-ParkinsonNCT05626608
Continuous Electrical Neuromodulation of the Globus Pallidus Intern in Parkinson's Disease by the Directional Electrode CARTESIA™
A study testing Classical ring stimulation and Stimulation in directional mode in people with Parkinson Disease, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Classical ring stimulation and Stimulation in directional mode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 28 Apr 2023to 28 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Uniersitaire de Montpellier
Montpellier, France, 34295
Laura CIF, PD, 0467337262 ext. +33, a-cif@chu-montpellier.fr
Gaëtan POULEN, PD, 0467337262 ext. +33, g-poulen@chu-montpellier.fr
About this study
Official title: Neuromodulation électrique Continue du Globus Pallidus Dans la Maladie de Parkinson Par l'électrode Directionnelle CARTESIA™
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.
Read the detailed description
Idiopathic Parkinson's disease represents the second degenerative disease after Alzheimer's disease, with progressive motor and non-motor symptoms, affecting the dopaminergic system (at the origin of the cardinal symptoms) and the other systems, cholinergic, noradrenergic and serotonergic (responsible for the dopa-resistant symptoms). The functional repercussions are important and a source of handicap in the more advanced phases of the disease. Many patients have benefited from the implantation of deep brain stimulation (DBS) electrodes, associated with dopaminergic replacement therapy, for the treatment of various motor signs of Parkinson's disease in the phase of motor fluctuations.
It is an advanced symptomatic therapy that does not prevent the progression of the disease. DBS is intended for Parkinson's patients in the phase of motor fluctuations. The aim of this treatment is to complement the therapeutic effect of pharmacological treatments that patients will have to continue as well as to compensate for certain effects induced by the drugs. The effectiveness of DBS therapy may decrease over time, especially in the context of a progressive pathology, and requires a change of batteries after several years (4 to 15 years, depending on the type of neurostimulator, non-rechargeable or rechargeable).
Beyond these constraints, this adaptable therapy has significantly improved the motor symptomatology of Parkinson's disease and the dyskinesias induced by pharmacological treatment. Technological advances in DBS could improve the therapeutic benefit of this technique and limit its side effects (dysarthria, hypophonia, oculomotor disorders, muscular contractions induced by the diffusion of the current), by using different modalities of brain stimulation. Implantation of Boston Scientific Cartesia™ directional electrodes for Parkinson's patients who are candidates for deep brain stimulation of the subthalamic nucleus (STN) would allow reorientation and variation of the volume of the stimulated structure, which could improve therapeutic performance, by stimulating key target volumes for obtaining the clinical effect, limiting side effects by diffusion of the current on neighboring structures. While using directional electrodes, it remains possible to program the stimulation in ring mode, conventional stimulation modality, in monopolar or bipolar.
The hypothesis is that the efficacy of DBS in directional mode will be more effective on the motor signs of Parkinson's disease compared to omnidirectional stimulation and bipolar mode, with a better tolerance profile (fewer side effects).
- Conditions
- Parkinson Disease
- Being tested
- Classical ring stimulation, Stimulation in directional mode
- Keywords
- Deep Brain Stimulation (DBS), Directional Stimulation, Subthalamic Nucleus (STN), Imaging Based Targeting, Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classical ring stimulationDevice
Unilateral or bilateral subthalamic nucleus stimulation in the treatment of Parkinson's disease using Boston Cartesia(TM) electrodes
Stimulation in directional modeDevice
Directional stimulation of the subthalamic nucleus in the treatment of Parkinson's disease using Boston Cartesia(TM) electrodes
| Study group | Role | What they receive |
|---|---|---|
| Directional | Experimental | Directional stimulation of the subthalamic nucleus in the treatment of Parkinson's disease using Boston Cartesia(TM) electrodes Receives: Device: Stimulation in directional mode |
| Conventional ring (Monopolar and Bipolar) | Active comparator | Unilateral or bilateral subthalamic nucleus stimulation in the treatment of Parkinson's disease using Boston Cartesia(TM) electrodes Receives: Device: Classical ring stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of motor scores
Comparison of motor scores between classical ring, monopolar or bipolar stimulation and stimulation in directional mode thanks to the part III of the UPDRS (Unified Parkinson Disease Rating Scale). The total score ranges from 0 (no disability) to 60 (total disability).
Measured: 12 months
Secondary outcomes (4)
Evaluation of patient acceptability for a stimulation modality
Evaluate for which programming modality(ies) the percentage of patients is most important
Measured: 12 months
Evaluation of the tolerance of different types of stimulation
Collection of induced side effects (dysarthria, hypertonia, oculomotor disorders)
Measured: 12 months
Evaluation of the clinical effects of programming functions
The additional percentage improvement in clinical scores versus directional stimulation without the use of the focus function at each visit.
Measured: 12 months
Evaluation of clinical effects of Directional programming mode
the clinical effects of different directions on motor symptoms will be evaluated and compared to the ring, monopolar and bipolar stimulation modalities, for the two plots evaluated as being the most effective in controlling motor signs and with the widest therapeutic window. The evaluation will be made thanks to the part III of the UPDRS (Unified Parkinson Disease Rating Scale). The total score ranges from 0 (no disability) to 60 (total disability).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start28 Apr 2023
- Primary completion28 Oct 2026 (estimated)
- Study completion28 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaëtan POULEN, PD, Study director, CHU de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626608
- Sponsor's protocol ID
- RECHMPL20_0466
- Acronym
- NEC-Parkinson
- Status last verified
- Nov 2025
- First submitted
- 7 Nov 2022
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation électrique Continue du Globus Pallidus Dans la Maladie de Parkinson Par l'électrode Directionnelle CARTESIA™
- ClinicalTrials.gov ID
- NCT05626608
- Acronym / sponsor ID
- NEC-Parkinson / RECHMPL20_0466
- Conditions
- Parkinson Disease
- Keywords
- Deep Brain Stimulation (DBS), Directional Stimulation, Subthalamic Nucleus (STN), Imaging Based Targeting, Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 28 Oct 2026 (estimated)
- Study completion
- 28 Oct 2026 (estimated)
- First posted
- 25 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Idiopathic Parkinson's disease represents the second degenerative disease after Alzheimer's disease, with progressive motor and non-motor symptoms, affecting the dopaminergic system (at the origin of the cardinal symptoms) and the other systems, cholinergic, noradrenergic and serotonergic (responsible for the dopa-resistant symptoms). The functional repercussions are important and a source of handicap in the more advanced phases of the disease. Many patients have benefited from the implantation of deep brain stimulation (DBS) electrodes, associated with dopaminergic replacement therapy, for the treatment of various motor signs of Parkinson's disease in the phase of motor fluctuations.
It is an advanced symptomatic therapy that does not prevent the progression of the disease. DBS is intended for Parkinson's patients in the phase of motor fluctuations. The aim of this treatment is to complement the therapeutic effect of pharmacological treatments that patients will have to continue as well as to compensate for certain effects induced by the drugs. The effectiveness of DBS therapy may decrease over time, especially in the context of a progressive pathology, and requires a change of batteries after several years (4 to 15 years, depending on the type of neurostimulator, non-rechargeable or rechargeable).
Beyond these constraints, this adaptable therapy has significantly improved the motor symptomatology of Parkinson's disease and the dyskinesias induced by pharmacological treatment. Technological advances in DBS could improve the therapeutic benefit of this technique and limit its side effects (dysarthria, hypophonia, oculomotor disorders, muscular contractions induced by the diffusion of the current), by using different modalities of brain stimulation. Implantation of Boston Scientific Cartesia™ directional electrodes for Parkinson's patients who are candidates for deep brain stimulation of the subthalamic nucleus (STN) would allow reorientation and variation of the volume of the stimulated structure, which could improve therapeutic performance, by stimulating key target volumes for obtaining the clinical effect, limiting side effects by diffusion of the current on neighboring structures. While using directional electrodes, it remains possible to program the stimulation in ring mode, conventional stimulation modality, in monopolar or bipolar.
The hypothesis is that the efficacy of DBS in directional mode will be more effective on the motor signs of Parkinson's disease compared to omnidirectional stimulation and bipolar mode, with a better tolerance profile (fewer side effects).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Directional | Experimental | Device: Stimulation in directional modeDirectional stimulation of the subthalamic nucleus in the treatment of Parkinson's disease using Boston Cartesia(TM) electrodes |
| Conventional ring (Monopolar and Bipolar) | Active comparator | Device: Classical ring stimulationUnilateral or bilateral subthalamic nucleus stimulation in the treatment of Parkinson's disease using Boston Cartesia(TM) electrodes |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Classical ring stimulationUnilateral or bilateral subthalamic nucleus stimulation in the treatment of Parkinson's disease using Boston Cartesia(TM) electrodes | Device | Conventional ring (Monopolar and Bipolar) |
| Stimulation in directional modeDirectional stimulation of the subthalamic nucleus in the treatment of Parkinson's disease using Boston Cartesia(TM) electrodes | Device | Directional |
Primary outcome
Comparison of motor scores
Time frame: 12 months
Comparison of motor scores between classical ring, monopolar or bipolar stimulation and stimulation in directional mode thanks to the part III of the UPDRS (Unified Parkinson Disease Rating Scale). The total score ranges from 0 (no disability) to 60 (total disability).
4 secondary outcomes
Evaluation of patient acceptability for a stimulation modality
Time frame: 12 months
Evaluation of the tolerance of different types of stimulation
Time frame: 12 months
Evaluation of the clinical effects of programming functions
Time frame: 12 months
Evaluation of clinical effects of Directional programming mode
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gaëtan POULEN, PD study director
CHU de Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classical ring stimulation and Stimulation in directional mode in people with Parkinson Disease, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gaëtan POULEN, PD (0467337262 ext. +33, g-poulen@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of motor scores (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.