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New Approaches in MRI at 3T Dedicated to Targeting Subthalamic Nucleus on Parkinsonian Patients (Optimise_3T)

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ClinicalTrials.gov Identifier: NCT02800460
Recruitment Status : Unknown
Verified August 2017 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was:  Recruiting
First Posted : June 15, 2016
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Parkinson Disease Procedure: fMRI-3T Not Applicable

Detailed Description:

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 that 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 quality of the implantation of stimulating electrodes into deep brain structures to achieve, particularly in the NST for PD patients, is crucial to obtain an excellent result. Accurate identification of these deep nuclei and especially the NST on MRI of each patient to be operated is an essential step and directly affects the smooth running of the surgery and the final clinical outcome.

The visualization of the NST on MRI remains difficult, variable between patients, requiring specific sequences or even sequences dedicated to this activity. In GHPS the investigators opted for the realization of an efficient particular sequence for viewing the NST but the latter has several disadvantages the first being its duration. Indeed, the patient needs to keep still, head fixed for 40 minutes, and this major constraint is sometimes impossible due to the importance of abnormal movements. The second is the variability between patients with visualization being sometimes inconspicuous. The third is the susceptibility of this sequence to flow artifacts at the level of the third ventricle that significantly disrupt viewing NST.

The new MRI techniques available for some years, especially at 3 Tesla should allow better visualization of the deep nuclei of the brain and NST in particular. Indeed, the high-field MRI has become an indispensable tool for both define the morphological and structural features but also functional and metabolic deep nuclei of the brain, particularly the NST.

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 sequence must be short to be feasible, minimizing patient discomfort, and evaluated 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Development of New Multi-contrasts Approaches by Magnetic Resonance Imaging at 3 Tesla Dedicated to Targeting Subthalamic Nucleus on Parkinsonian Patients.
Actual Study Start Date : October 10, 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Deep brain stimulation with fMRI-3T
Patients will have a 3T-fMRI before their usual MRI-1,5T
Procedure: fMRI-3T
fMRI-3T will be performed during the visit 1: day of anesthesia consultation (this fMRI-3T will last approximately one hour)




Primary Outcome Measures :
  1. Measure of the distance between two target points within the NST defined on a optimized Flair sequence on a research 3T MRI and on a routine T2 sequence acquired at 1.5T. [ Time Frame: Visit 3 : day of surgery ]
    The measure will be performed with the new 3T MRI (Flair sequence) conducted as part of this protocol and the clinical routine on the 1,5T MRI (T2 sequences).


Secondary Outcome Measures :
  1. Measure of target contouring with a quantitative scale [ Time Frame: Visit 3: Day of surgery ]
    Target contouring from 3T-fMRI and from 1,5T-MRI

  2. Measure of target volume [ Time Frame: Visit 3: Day of surgery ]
    Volume measures with 3T-fMRI and with the 1.5-MRI



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800460


Contacts
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Contact: Carine Karachi, MD 01 42 16 33 29 ext +33 carine.karachi@gmail.com
Contact: Eric Bardinet, PhD 01 57 27 46 36 ext +33 eric.bardinet@upmc.fr

Locations
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France
GHPS Recruiting
Paris, Ile De France, France, 75651
Contact: Carine Karachi, MCU-PH    01 42 16 33 29    carine.karachi@gmail.com   
Contact: Eric Bardinet, PhD    01 57 27 46 36    eric.bardinet@upmc.fr   
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Publications:

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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT02800460    
Other Study ID Numbers: C15-90
2016-A00231-50 ( Registry Identifier: IDRCB )
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Subthalamic nucleus
Basal ganglia
Parkinson disease
Magnetic Resonance Imaging
Susceptibility-Weighted Imaging
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases