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

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
fMRI-3T
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson Disease focused on measuring Subthalamic nucleus, Basal ganglia, Parkinson disease, Magnetic Resonance Imaging, Susceptibility-Weighted Imaging

Eligibility Criteria

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

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

Sites / Locations

  • GHPSRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Deep brain stimulation with fMRI-3T

Arm Description

Patients will have a 3T-fMRI before their usual MRI-1,5T

Outcomes

Primary Outcome Measures

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.
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

Measure of target contouring with a quantitative scale
Target contouring from 3T-fMRI and from 1,5T-MRI
Measure of target volume
Volume measures with 3T-fMRI and with the 1.5-MRI

Full Information

First Posted
June 1, 2016
Last Updated
October 31, 2017
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT02800460
Brief Title
New Approaches in MRI at 3T Dedicated to Targeting Subthalamic Nucleus on Parkinsonian Patients
Acronym
Optimise_3T
Official Title
Development of New Multi-contrasts Approaches by Magnetic Resonance Imaging at 3 Tesla Dedicated to Targeting Subthalamic Nucleus on Parkinsonian Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 10, 2016 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Subthalamic nucleus, Basal ganglia, Parkinson disease, Magnetic Resonance Imaging, Susceptibility-Weighted Imaging

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Deep brain stimulation with fMRI-3T
Arm Type
Other
Arm Description
Patients will have a 3T-fMRI before their usual MRI-1,5T
Intervention Type
Procedure
Intervention Name(s)
fMRI-3T
Intervention Description
fMRI-3T will be performed during the visit 1: day of anesthesia consultation (this fMRI-3T will last approximately one hour)
Primary Outcome Measure Information:
Title
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.
Description
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).
Time Frame
Visit 3 : day of surgery
Secondary Outcome Measure Information:
Title
Measure of target contouring with a quantitative scale
Description
Target contouring from 3T-fMRI and from 1,5T-MRI
Time Frame
Visit 3: Day of surgery
Title
Measure of target volume
Description
Volume measures with 3T-fMRI and with the 1.5-MRI
Time Frame
Visit 3: Day of surgery

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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carine Karachi, MD
Phone
01 42 16 33 29
Ext
+33
Email
carine.karachi@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Bardinet, PhD
Phone
01 57 27 46 36
Ext
+33
Email
eric.bardinet@upmc.fr
Facility Information:
Facility Name
GHPS
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75651
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carine Karachi, MCU-PH
Phone
01 42 16 33 29
Email
carine.karachi@gmail.com
First Name & Middle Initial & Last Name & Degree
Eric Bardinet, PhD
Phone
01 57 27 46 36
Email
eric.bardinet@upmc.fr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11554003
Citation
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New Approaches in MRI at 3T Dedicated to Targeting Subthalamic Nucleus on Parkinsonian Patients

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