search
Back to results

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

Primary Purpose

Parkinson Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Classical ring stimulation
Stimulation in directional mode
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Deep Brain Stimulation (DBS), Directional Stimulation, Subthalamic Nucleus (STN), Imaging Based Targeting, Parkinson's Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Uniersitaire de Montpellier

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Directional

Conventional ring (Monopolar and Bipolar)

Arm Description

Directional stimulation of the subthalamic nucleus in the treatment of Parkinson's disease using Boston Cartesia(TM) electrodes

Unilateral or bilateral subthalamic nucleus stimulation in the treatment of Parkinson's disease using Boston Cartesia(TM) electrodes

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Evaluation of patient acceptability for a stimulation modality
Evaluate for which programming modality(ies) the percentage of patients is most important
Evaluation of the tolerance of different types of stimulation
Collection of induced side effects (dysarthria, hypertonia, oculomotor disorders)
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.
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).

Full Information

First Posted
November 7, 2022
Last Updated
November 28, 2022
Sponsor
University Hospital, Montpellier
search

1. Study Identification

Unique Protocol Identification Number
NCT05626608
Brief Title
Continuous Electrical Neuromodulation of the Globus Pallidus Intern in Parkinson's Disease by the Directional Electrode CARTESIA™
Acronym
NEC-Parkinson
Official Title
Neuromodulation électrique Continue du Globus Pallidus Dans la Maladie de Parkinson Par l'électrode Directionnelle CARTESIA™
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2022 (Anticipated)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Deep Brain Stimulation (DBS), Directional Stimulation, Subthalamic Nucleus (STN), Imaging Based Targeting, Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Two of the 4 investigators will not be aware of the stimulation modality programmed in the patient.
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Directional
Arm Type
Experimental
Arm Description
Directional stimulation of the subthalamic nucleus in the treatment of Parkinson's disease using Boston Cartesia(TM) electrodes
Arm Title
Conventional ring (Monopolar and Bipolar)
Arm Type
Active Comparator
Arm Description
Unilateral or bilateral subthalamic nucleus stimulation in the treatment of Parkinson's disease using Boston Cartesia(TM) electrodes
Intervention Type
Device
Intervention Name(s)
Classical ring stimulation
Intervention Description
Unilateral or bilateral subthalamic nucleus stimulation in the treatment of Parkinson's disease using Boston Cartesia(TM) electrodes
Intervention Type
Device
Intervention Name(s)
Stimulation in directional mode
Intervention Description
Directional stimulation of the subthalamic nucleus in the treatment of Parkinson's disease using Boston Cartesia(TM) electrodes
Primary Outcome Measure Information:
Title
Comparison of motor scores
Description
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Evaluation of patient acceptability for a stimulation modality
Description
Evaluate for which programming modality(ies) the percentage of patients is most important
Time Frame
12 months
Title
Evaluation of the tolerance of different types of stimulation
Description
Collection of induced side effects (dysarthria, hypertonia, oculomotor disorders)
Time Frame
12 months
Title
Evaluation of the clinical effects of programming functions
Description
The additional percentage improvement in clinical scores versus directional stimulation without the use of the focus function at each visit.
Time Frame
12 months
Title
Evaluation of clinical effects of Directional programming mode
Description
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).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura CIF, PD
Phone
0467337262
Ext
+33
Email
a-cif@chu-montpellier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Gaëtan POULEN, PD
Phone
0467337262
Ext
+33
Email
g-poulen@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe COUBES, PD PH
Organizational Affiliation
CHU de Montpellier
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier Uniersitaire de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura CIF, PD
Phone
0467337262
Ext
+33
Email
a-cif@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Gaëtan POULEN, PD
Phone
0467337262
Ext
+33
Email
g-poulen@chu-montpellier.fr

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs