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

NCT05626608 | Recruiting DMC

• 1 other identifier: RECHMPL20_0466
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Deep Brain Stimulation (DBS); Directional Stimulation; Subthalamic Nucleus (STN); Imaging Based Targeting; Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• 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).

  12 months

Secondary Outcomes (4)

• Evaluation of patient acceptability for a stimulation modality

  12 months

• Evaluation of the tolerance of different types of stimulation

  12 months

• Evaluation of the clinical effects of programming functions

  12 months

• Evaluation of clinical effects of Directional programming mode

  12 months

Study Arms (2)

Directional

EXPERIMENTAL

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

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

Device: Classical ring stimulation

Interventions

Classical ring stimulation DEVICE

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

Conventional ring (Monopolar and Bipolar)

Stimulation in directional mode DEVICE

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

Directional

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Centre Hospitalier Uniersitaire de Montpellier

Montpellier, France, 34295, France

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Gaëtan POULEN, PD

  CHU de Montpellier

  STUDY DIRECTOR

Central Study Contacts

Gaëtan POULEN, PD

CONTACT

0467337262; g-poulen@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Two of the 4 investigators will not be aware of the stimulation modality programmed in the patient.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 25, 2022
• Study Start: April 28, 2023
• Primary Completion (Estimated): October 28, 2026
• Study Completion (Estimated): October 28, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

FR (1)