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NCT02800460Completed

New Approaches in MRI at 3T Dedicated to Targeting Subthalamic Nucleus on Parkinsonian Patients

Development of New Multi-contrasts Approaches by Magnetic Resonance Imaging at 3 Tesla Dedicated to Targeting Subthalamic Nucleus on Parkinsonian Patients.

Source: ClinicalTrials.gov · Last updated 21 Sept 2026

Brief summary (registry, in English)

Deep brain stimulation (DBS) of the subthalamic nucleus (STN) is a validated procedure, used in many French and international centers for the treatment of severe forms of Parkinson's disease (PD). The improvement of parkinsonian motor symptoms by stimulation of the STN is 50 to 80% on average. The main advantage of DBS is that the surgery has low morbidity and mortality, it is adaptable to the patient's symptoms and its effect is reversible. This treatment is now a routine and more than 85,000 patients worldwide have benefited from the installation of this system. Since 1997, this treatment is available to patients followed in the Pitié Salpêtrière (GHPS). The accuracy of preoperative anatomic targeting in stereotactic neurosurgery will improve with the use of high-field MRI. However, several new issues and inherent in that high-field MRI should be evaluated before the images can be used directly. The chosen sequences must be short to be feasible, minimizing patient discomfort, and evaluated on several patients to ensure the low interindividual variability. In addition, the quality of the display on all of the sections should provide a reliable three-dimensional information. Finally, the quality of targeting and its possible improvement should be checked.

Status (registry)
Completed
Study type
Interventional
Enrollment
105 (actual)
First submitted
1 Jun 2016
Start date
Oct 2016
Primary completion date
Jun 2025
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
NCT number
NCT02800460

What you commit to

  • Study type: Interventional
  • Participants enrolled: 105
  • From Oct 2016 to the primary completion date, Jun 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • scalable psychiatric pathology;
  • Dementia (MMS \<24/30);
  • Existence of against-indications to MRI (cardiac or neural stimulator, ferromagnetic surgical clips, implants and metal objects, intraocular foreign bodies, pregnancy, claustrophobia).

Other

  • Patients carry an apomorphine pump used in single and continuous treatment;
  • Persons under guardianship, trusteeship or any other administrative or judicial deprivation of rights and freedom

Who the study is looking for

  • Diagnosis of idiopathic Parkinson's disease (according to the criteria of the "United Kingdom Parkinson's Disease Society Brain Bank";
  • Age between 18 and 70 years
  • motor complications in the form of fluctuations in motor state or induced dyskinesias dopaminergic therapy, despite optimal medical treatment;
  • Excellent responsiveness to levodopa (improved motor UPDRS score of higher than 50% during the acute test with levodopa)
  • People who voluntarily accepted and intelligently participate in the study (signing a written consent)
  • Patient receiving social health insurance

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
GHPS
Coordinator of this site? Confirm its status
ParisFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.