Probabilistic Targeting of the VIM

NCT03696420 | Completed

• 1 other identifier: CHUBX 2018/26
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Essential Tremor; Deep Brain Stimulation

Keywords

Probabilistic targeting; VIM-DBS; Machine-learning; Essential Tremor

Outcome Measures

Primary Outcomes (1)

• Euclidian distance between the predicted target and the center of the active contact of the DBS lead

  Euclidian distance in milimeter measured on the fusion between post-operative CT-scan and pre-operative MRI.

  6 month after DBS surgery

Study Arms (1)

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

Interventions

Coordinates of active plots and VIM landmarks calculation OTHER

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.

DBS surgery targeting the VIM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient who underwent a DBS surgery targeting the VIM at Bordeaux University Hospital

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Institut National de Recherche en Informatique et en Automatique: collaborator

Study Sites (1)

Bordeaux University Hospital

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Nejib ZEMZEMI, MD-PhD

  Institut National de Recherche en Informatique et en Automatique

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 4, 2018
• Study Start: November 30, 2018
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)