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Probabilistic Targeting of the VIM (PROBA-VIM)

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ClinicalTrials.gov Identifier: NCT03696420
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : January 14, 2019
Sponsor:
Collaborator:
Institut National de Recherche en Informatique et en Automatique
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
After having included the most improved patients by DBS among those implanted in Bordeaux Hospital University, and having defined the most active plots on tremor by its prospective grading on Fahn-Tolosa-Marin (FTM) scale and accelerometry, coordinates of active plots and landmarks will be calculated on post-operative imaging. Association between landmarks and active plots coordinates will be modelled with machine-learning algorithms. The aim is to retrieve the position of the VIM on the basis of the landmarks coordinates.

Condition or disease Intervention/treatment
Essential Tremor Deep Brain Stimulation Other: Coordinates of active plots and VIM landmarks calculation

Detailed Description:
The intermedius ventralis nucleus of the thalamus (VIM), which represents the target for deep brain stimulation (DBS) in essential tremor, still remains invisible to imaging in spite of the development of new MR sequences. The coordinates currently used in the classical (ACPC) system are so imprecise that per-operative electrophysiology is mandatory to locate the exact position of this target. Micro-electrode recordings (MER) however improve hemorrhagic risk and may be poorly tolerated by patients operated on 7 to 8 hours under local anaesthesia. Based on litterature review, no one tried to retrieve the position of the VIM from anatomical landmarks coordinates in the era of MRI. The patients operated will be clinically tested to define those very well improved by the stimulation. Stimulation efficacy will be assessed by comparing the clinical evaluation (FTM scale) with and without stimulation, and the four contacts of each electrode will be tested clinically, with an accelerometer and an electromyography to determine which one is the most active on tremor. Coordinates of the anatomical landmarks will be calculated on the pre-operative MRI and those of the active plots on the fusion between post-operative CT-scan and pre-operative MRI. These coordinates will be analysed by machine-learning algorithms to create a model predicting the position of the active contacts from the coordinates of the landmarks.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Probabilistic Determination of the Ventro-intermediate Nucleus of the Thalamus (VIM) Coordinates From Radio-anatomical Landmarks on 1.5 Tesla MRI
Actual Study Start Date : November 30, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor

Group/Cohort Intervention/treatment
DBS surgery targeting the VIM
Patient who underwent a DBS surgery targeting the VIM at Bordeaux University Hospital
Other: Coordinates of active plots and VIM landmarks calculation
Stimulation efficacy will be assessed by comparing, according to usual care, the clinical evaluation (FTM scale) with and without stimulation, and the four contacts of each electrode will be tested clinically, with an accelerometer and an electromyography to determine which one is the most active on tremor. Coordinates of the anatomical landmarks will be calculated on the pre-operative MRI and those of the active plots on the fusion between post-operative CT-scan and pre-operative MRI.




Primary Outcome Measures :
  1. Euclidian distance between the predicted target and the center of the active contact of the DBS lead [ Time Frame: 6 month after DBS surgery ]
    Euclidian distance in milimeter measured on the fusion between post-operative CT-scan and pre-operative MRI.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient who underwent a DBS surgery targeting the VIM at Bordeaux University Hospital
Criteria

Inclusion Criteria:

  • patient older than 18 years
  • who underwent a DBS surgery targeting the VIM at Bordeaux University Hospital
  • in the strict indication of the essential tremor
  • with an excellent post-operative result defined by a complete withdrawal of medication, a stability of the stimulation effects without any setting adjustments since at least 3 months and an improvement of more than 66% on the FTM scale between OFF and ON-stimulation assessments.

Exclusion Criteria:

- patients who underwent a DBS surgery targeting the VIM for different indications (Parkinson's disease for instance), patients with a poor post-operative efficacy


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): NCT03696420


Contacts
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Contact: Julien ENGELHARDT, MD 05 56 79 55 77 ext +33 julien.engelhardt@chu-bordeaux.fr
Contact: Olivier BRANCHARD 05 57 82 06 97 ext +33 olivier.branchard@chu-bordeaux.fr

Locations
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France
Bordeaux University Hospital Recruiting
Bordeaux, France, 33076
Contact: Julien ENGELHARDT, MD    05 56 79 55 77 ext +33    julien.engelhardt@chu-bordeaux.fr   
Contact: Olivier BRANCHARD    05 57 82 06 97 ext +33    olivier.branchard@chu-bordeaux.fr   
Sub-Investigator: Dominique GUEHL, MD-PhD         
Sub-Investigator: Emmanuel CUNY, MD-PhD         
Principal Investigator: Julien ENGELHARDT, MD-PhD         
Sponsors and Collaborators
University Hospital, Bordeaux
Institut National de Recherche en Informatique et en Automatique
Investigators
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Study Chair: Nejib ZEMZEMI, MD-PhD Institut National de Recherche en Informatique et en Automatique
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03696420    
Other Study ID Numbers: CHUBX 2018/26
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Probabilistic targeting
VIM-DBS
Machine-learning
Essential Tremor
Additional relevant MeSH terms:
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Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Movement Disorders
Central Nervous System Diseases