Parkinson DiseaseOptimise_3TNCT02800460
New Approaches in MRI at 3T Dedicated to Targeting Subthalamic Nucleus on Parkinsonian Patients
A study testing fMRI-3T in people with Parkinson Disease, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- fMRI-3T
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteFrance
- Study dates
- 12 Oct 2016to 9 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of New Multi-contrasts Approaches by Magnetic Resonance Imaging at 3 Tesla Dedicated to Targeting Subthalamic Nucleus on Parkinsonian Patients.
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- fMRI-3T
- Keywords
- Subthalamic nucleus, Basal ganglia, Parkinson disease, Magnetic Resonance Imaging, Susceptibility-Weighted Imaging
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRI-3TProcedure or surgery
fMRI-3T will be performed during the visit 1: day of anesthesia consultation (this fMRI-3T will last approximately one hour)
| Study group | Role | What they receive |
|---|---|---|
| Deep brain stimulation with fMRI-3T | Other | Patients will have a 3T-fMRI before their usual MRI-1,5T Receives: Procedure: fMRI-3T |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Visit 3 : day of surgery
Secondary outcomes (2)
Measure of target contouring with a quantitative scale
Target contouring from 3T-fMRI and from 1,5T-MRI
Measured: Visit 3: Day of surgery
Measure of target volume
Volume measures with 3T-fMRI and with the 1.5-MRI
Measured: Visit 3: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start12 Oct 2016
- Primary completion8 Jun 2025
- Study completion9 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800460
- Sponsor's protocol ID
- C15-90
- Other IDs
- 2016-A00231-50
- Acronym
- Optimise_3T
- Status last verified
- Jul 2026
- First submitted
- 1 Jun 2016
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Poulen G, Tempier N, Temiz G, Fernandez Vidal S, Navarro S, Vidailhet M, Coubes P, Lau B, Welter ML, Hainque E, Karachi C. Deep Brain Stimulation of the Internal Pallidum Modulates the Mesencephalic Locomotor Pathway in Improved Cervical Dystonic Patients. Mov Disord Clin Pract. 2026 Jun;13(6):1496-1502. doi: 10.1002/mdc3.70518. Epub 2026 Jan 16.
PubMed 41546185Temiz G, Santin MDN, Olivier C, Collomb-Clerc A, Fernandez-Vidal S, Hainque E, Bardinet E, Lau B, Francois C, Karachi C, Welter ML. Freezing of gait depends on cortico-subthalamic network recruitment following STN-DBS in PD patients. Parkinsonism Relat Disord. 2022 Nov;104:49-57. doi: 10.1016/j.parkreldis.2022.10.002. Epub 2022 Oct 8.
PubMed 36242900Benabid AL, Koudsie A, Benazzouz A, Piallat B, Krack P, Limousin-Dowsey P, Lebas JF, Pollak P. Deep brain stimulation for Parkinson's disease. Adv Neurol. 2001;86:405-12. No abstract available.
PubMed 11554003Bejjani BP, Dormont D, Pidoux B, Yelnik J, Damier P, Arnulf I, Bonnet AM, Marsault C, Agid Y, Philippon J, Cornu P. Bilateral subthalamic stimulation for Parkinson's disease by using three-dimensional stereotactic magnetic resonance imaging and electrophysiological guidance. J Neurosurg. 2000 Apr;92(4):615-25. doi: 10.3171/jns.2000.92.4.0615.
PubMed 10761650Egidi M, Rampini P, Locatelli M, Farabola M, Priori A, Pesenti A, Tamma F, Caputo E, Chiesa V, Villani RM. Visualisation of the subthalamic nucleus: a multiple sequential image fusion (MuSIF) technique for direct stereotaxic localisation and postoperative control. Neurol Sci. 2002 Sep;23 Suppl 2:S71-2. doi: 10.1007/s100720200075.
PubMed 12548349Longhi M, Ricciardi G, Tommasi G, Nicolato A, Foroni R, Bertolasi L, Beltramello A, Moretto G, Tinazzi M, Gerosa M. The Role of 3T Magnetic Resonance Imaging for Targeting the Human Subthalamic Nucleus in Deep Brain Stimulation for Parkinson Disease. J Neurol Surg A Cent Eur Neurosurg. 2015 May;76(3):181-9. doi: 10.1055/s-0033-1354749. Epub 2015 Mar 12.
PubMed 25764475Lefranc M, Derrey S, Merle P, Tir M, Constans JM, Montpellier D, Macron JM, Le Gars D, Peltier J, Baledentt O, Krystkowiak P. High-resolution 3-dimensional T2*-weighted angiography (HR 3-D SWAN): an optimized 3-T magnetic resonance imaging sequence for targeting the subthalamic nucleus. Neurosurgery. 2014 Jun;74(6):615-26; discussion 627. doi: 10.1227/NEU.0000000000000319.
PubMed 24535261Yelnik J, Bardinet E, Dormont D, Malandain G, Ourselin S, Tande D, Karachi C, Ayache N, Cornu P, Agid Y. A three-dimensional, histological and deformable atlas of the human basal ganglia. I. Atlas construction based on immunohistochemical and MRI data. Neuroimage. 2007 Jan 15;34(2):618-38. doi: 10.1016/j.neuroimage.2006.09.026. Epub 2006 Nov 15.
PubMed 17110133Breit S, LeBas JF, Koudsie A, Schulz J, Benazzouz A, Pollak P, Benabid AL. Pretargeting for the implantation of stimulation electrodes into the subthalamic nucleus: a comparative study of magnetic resonance imaging and ventriculography. Neurosurgery. 2006 Feb;58(1 Suppl):ONS83-95. doi: 10.1227/01.NEU.0000192689.00427.C2.
PubMed 16543877Cheng CH, Huang HM, Lin HL, Chiou SM. 1.5T versus 3T MRI for targeting subthalamic nucleus for deep brain stimulation. Br J Neurosurg. 2014 Aug;28(4):467-70. doi: 10.3109/02688697.2013.854312. Epub 2013 Nov 5.
PubMed 24191703Patil PG, Conrad EC, Aldridge JW, Chenevert TL, Chou KL. The anatomical and electrophysiological subthalamic nucleus visualized by 3-T magnetic resonance imaging. Neurosurgery. 2012 Dec;71(6):1089-95; discussion 1095. doi: 10.1227/NEU.0b013e318270611f.
PubMed 22948201Marques JP, Kober T, Krueger G, van der Zwaag W, Van de Moortele PF, Gruetter R. MP2RAGE, a self bias-field corrected sequence for improved segmentation and T1-mapping at high field. Neuroimage. 2010 Jan 15;49(2):1271-81. doi: 10.1016/j.neuroimage.2009.10.002. Epub 2009 Oct 9.
PubMed 19819338Liu T, Eskreis-Winkler S, Schweitzer AD, Chen W, Kaplitt MG, Tsiouris AJ, Wang Y. Improved subthalamic nucleus depiction with quantitative susceptibility mapping. Radiology. 2013 Oct;269(1):216-23. doi: 10.1148/radiol.13121991. Epub 2013 May 14.
PubMed 23674786Xiao Y, Fonov VS, Beriault S, Gerard I, Sadikot AF, Pike GB, Collins DL. Patch-based label fusion segmentation of brainstem structures with dual-contrast MRI for Parkinson's disease. Int J Comput Assist Radiol Surg. 2015 Jul;10(7):1029-41. doi: 10.1007/s11548-014-1119-4. Epub 2014 Sep 24.
PubMed 25249471Starr PA, Martin AJ, Ostrem JL, Talke P, Levesque N, Larson PS. Subthalamic nucleus deep brain stimulator placement using high-field interventional magnetic resonance imaging and a skull-mounted aiming device: technique and application accuracy. J Neurosurg. 2010 Mar;112(3):479-90. doi: 10.3171/2009.6.JNS081161.
PubMed 19681683
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of New Multi-contrasts Approaches by Magnetic Resonance Imaging at 3 Tesla Dedicated to Targeting Subthalamic Nucleus on Parkinsonian Patients.
- ClinicalTrials.gov ID
- NCT02800460
- Acronym / sponsor ID
- Optimise_3T / C15-90
- Conditions
- Parkinson Disease
- Keywords
- Subthalamic nucleus, Basal ganglia, Parkinson disease, Magnetic Resonance Imaging, Susceptibility-Weighted Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 12 Oct 2016 (actual)
- Primary completion
- 8 Jun 2025 (actual)
- Study completion
- 9 Nov 2025 (actual)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep brain stimulation with fMRI-3T | Other | Procedure: fMRI-3TPatients will have a 3T-fMRI before their usual MRI-1,5T |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRI-3TfMRI-3T will be performed during the visit 1: day of anesthesia consultation (this fMRI-3T will last approximately one hour) | Procedure or surgery | Deep brain stimulation with fMRI-3T |
Primary outcome
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).
2 secondary outcomes
Measure of target contouring with a quantitative scale
Time frame: Visit 3: Day of surgery
Measure of target volume
Time frame: Visit 3: Day of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 41546185Poulen G, Tempier N, Temiz G, Fernandez Vidal S, Navarro S, Vidailhet M, Coubes P, Lau B, Welter ML, Hainque E, Karachi C. Deep Brain Stimulation of the Internal Pallidum Modulates the Mesencephalic Locomotor Pathway in Improved Cervical Dystonic Patients. Mov Disord Clin Pract. 2026 Jun;13(6):1496-1502. doi: 10.1002/mdc3.70518. Epub 2026 Jan 16.
- Background: PubMed 36242900Temiz G, Santin MDN, Olivier C, Collomb-Clerc A, Fernandez-Vidal S, Hainque E, Bardinet E, Lau B, Francois C, Karachi C, Welter ML. Freezing of gait depends on cortico-subthalamic network recruitment following STN-DBS in PD patients. Parkinsonism Relat Disord. 2022 Nov;104:49-57. doi: 10.1016/j.parkreldis.2022.10.002. Epub 2022 Oct 8.
- Background: PubMed 11554003Benabid AL, Koudsie A, Benazzouz A, Piallat B, Krack P, Limousin-Dowsey P, Lebas JF, Pollak P. Deep brain stimulation for Parkinson's disease. Adv Neurol. 2001;86:405-12. No abstract available.
- Background: PubMed 10761650Bejjani BP, Dormont D, Pidoux B, Yelnik J, Damier P, Arnulf I, Bonnet AM, Marsault C, Agid Y, Philippon J, Cornu P. Bilateral subthalamic stimulation for Parkinson's disease by using three-dimensional stereotactic magnetic resonance imaging and electrophysiological guidance. J Neurosurg. 2000 Apr;92(4):615-25. doi: 10.3171/jns.2000.92.4.0615.
- Background: PubMed 12548349Egidi M, Rampini P, Locatelli M, Farabola M, Priori A, Pesenti A, Tamma F, Caputo E, Chiesa V, Villani RM. Visualisation of the subthalamic nucleus: a multiple sequential image fusion (MuSIF) technique for direct stereotaxic localisation and postoperative control. Neurol Sci. 2002 Sep;23 Suppl 2:S71-2. doi: 10.1007/s100720200075.
- Background: PubMed 25764475Longhi M, Ricciardi G, Tommasi G, Nicolato A, Foroni R, Bertolasi L, Beltramello A, Moretto G, Tinazzi M, Gerosa M. The Role of 3T Magnetic Resonance Imaging for Targeting the Human Subthalamic Nucleus in Deep Brain Stimulation for Parkinson Disease. J Neurol Surg A Cent Eur Neurosurg. 2015 May;76(3):181-9. doi: 10.1055/s-0033-1354749. Epub 2015 Mar 12.
- Background: PubMed 24535261Lefranc M, Derrey S, Merle P, Tir M, Constans JM, Montpellier D, Macron JM, Le Gars D, Peltier J, Baledentt O, Krystkowiak P. High-resolution 3-dimensional T2*-weighted angiography (HR 3-D SWAN): an optimized 3-T magnetic resonance imaging sequence for targeting the subthalamic nucleus. Neurosurgery. 2014 Jun;74(6):615-26; discussion 627. doi: 10.1227/NEU.0000000000000319.
- Background: PubMed 17110133Yelnik J, Bardinet E, Dormont D, Malandain G, Ourselin S, Tande D, Karachi C, Ayache N, Cornu P, Agid Y. A three-dimensional, histological and deformable atlas of the human basal ganglia. I. Atlas construction based on immunohistochemical and MRI data. Neuroimage. 2007 Jan 15;34(2):618-38. doi: 10.1016/j.neuroimage.2006.09.026. Epub 2006 Nov 15.
- Background: PubMed 16543877Breit S, LeBas JF, Koudsie A, Schulz J, Benazzouz A, Pollak P, Benabid AL. Pretargeting for the implantation of stimulation electrodes into the subthalamic nucleus: a comparative study of magnetic resonance imaging and ventriculography. Neurosurgery. 2006 Feb;58(1 Suppl):ONS83-95. doi: 10.1227/01.NEU.0000192689.00427.C2.
- Background: PubMed 24191703Cheng CH, Huang HM, Lin HL, Chiou SM. 1.5T versus 3T MRI for targeting subthalamic nucleus for deep brain stimulation. Br J Neurosurg. 2014 Aug;28(4):467-70. doi: 10.3109/02688697.2013.854312. Epub 2013 Nov 5.
- Background: PubMed 22948201Patil PG, Conrad EC, Aldridge JW, Chenevert TL, Chou KL. The anatomical and electrophysiological subthalamic nucleus visualized by 3-T magnetic resonance imaging. Neurosurgery. 2012 Dec;71(6):1089-95; discussion 1095. doi: 10.1227/NEU.0b013e318270611f.
- Background: PubMed 19819338Marques JP, Kober T, Krueger G, van der Zwaag W, Van de Moortele PF, Gruetter R. MP2RAGE, a self bias-field corrected sequence for improved segmentation and T1-mapping at high field. Neuroimage. 2010 Jan 15;49(2):1271-81. doi: 10.1016/j.neuroimage.2009.10.002. Epub 2009 Oct 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI-3T in people with Parkinson Disease, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02800460, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.