---
title: Reduce tremor and involuntary movements
nct_id: NCT05626608
phase: NA
status: RECRUITING
sponsor: University Hospital, Montpellier
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT05626608"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05626608"
last_fetched: "2026-05-10T14:07:25.316Z"
source: "Parkinson's Pathways (curated)"
---
# Reduce tremor and involuntary movements

**Goal (in five words):** Reduce tremor and involuntary movements

**Official Title:** Neuromodulation électrique Continue du Globus Pallidus Dans la Maladie de Parkinson Par l'électrode Directionnelle CARTESIA™

**Trial ID:** [NCT05626608](https://clinicaltrials.gov/study/NCT05626608)

## Key Facts

- **Phase:** NA
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** University Hospital, Montpellier
- **Target Enrollment:** 10 participants
- **Start Date:** 2023-04-28
- **Completion Date:** 2026-10-28
- **Conditions:** Parkinson Disease
- **Interventions:** Classical ring stimulation, Stimulation in directional mode
- **Intervention Types:** DEVICE

## Summary For Families

Aimed at cutting down disabling tremor and major motor fluctuations or dyskinesias in people with Parkinson's who still respond to levodopa. It compares conventional ring deep brain stimulation to directional stimulation using the CARTESIA™ electrode in the globus pallidus; directional mode steers current toward problem areas to boost symptom control and reduce stimulation side effects, and DBS generally works alongside levodopa and can allow lower medication doses. Looking for adults 18 to 70 with bilateral idiopathic PD for several years, a clear levodopa response (about 30% improvement), significant motor symptoms despite meds, an off‑med UPDRS III score over 25, and who are candidates for bilateral DBS surgery. People with dementia, severe psychiatric illness, MRI or anesthesia contraindications, pregnancy, inability to complete long follow up, or without informed consent are excluded.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL

### Full 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
```

## Locations (1)

- Centre Hospitalier Uniersitaire de Montpellier, Montpellier, France, France _(43.6109, 3.8763)_
  - Laura CIF, PD — (CONTACT) — 0467337262 — a-cif@chu-montpellier.fr
  - Gaëtan POULEN, PD — (CONTACT) — 0467337262 — g-poulen@chu-montpellier.fr

## Central Contacts

- Gaëtan POULEN, PD — (CONTACT) — 0467337262 — g-poulen@chu-montpellier.fr

---

*Canonical: https://parkinsonspathways.com/trial/NCT05626608*  
*HTML version: https://parkinsonspathways.com/trial/NCT05626608*  
*Source data: https://clinicaltrials.gov/study/NCT05626608*