Essential TremorPROBA-VIMNCT03696420
Probabilistic Targeting of the VIM
An observational study of Essential Tremor and Deep Brain Stimulation, run by University Hospital, Bordeaux at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Tremor, Deep Brain Stimulation
- What is being tested?
- Coordinates of active plots and VIM landmarks calculation
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2018to 30 Nov 2018
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient who underwent a DBS surgery targeting the VIM at Bordeaux University Hospital
Who may be able to join
- 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.
Who cannot join
- patients who underwent a DBS surgery targeting the VIM for different indications (Parkinson's disease for instance), patients with a poor post-operative efficacy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Probabilistic Determination of the Ventro-intermediate Nucleus of the Thalamus (VIM) Coordinates From Radio-anatomical Landmarks on 1.5 Tesla MRI
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.
Read the 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.
- Conditions
- Essential Tremor, Deep Brain Stimulation
- Being tested
- Coordinates of active plots and VIM landmarks calculation
- Keywords
- Probabilistic targeting, VIM-DBS, Machine-learning, Essential Tremor
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coordinates of active plots and VIM landmarks calculationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| DBS surgery targeting the VIM | Patient who underwent a DBS surgery targeting the VIM at Bordeaux University Hospital Receives: Other: Coordinates of active plots and VIM landmarks calculation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month after DBS surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start30 Nov 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche en Informatique et en Automatique
- Responsible party
- Sponsor
- Investigators
- Nejib ZEMZEMI, MD-PhD, Study chair, Institut National de Recherche en Informatique et en Automatique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696420
- Sponsor's protocol ID
- CHUBX 2018/26
- Acronym
- PROBA-VIM
- Status last verified
- Sep 2021
- First submitted
- 3 Oct 2018
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probabilistic Determination of the Ventro-intermediate Nucleus of the Thalamus (VIM) Coordinates From Radio-anatomical Landmarks on 1.5 Tesla MRI
- ClinicalTrials.gov ID
- NCT03696420
- Acronym / sponsor ID
- PROBA-VIM / CHUBX 2018/26
- Conditions
- Essential Tremor, Deep Brain Stimulation
- Keywords
- Probabilistic targeting, VIM-DBS, Machine-learning, Essential Tremor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Institut National de Recherche en Informatique et en Automatique
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 4 Oct 2018 (actual)
- 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.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DBS surgery targeting the VIM | – | Other: Coordinates of active plots and VIM landmarks calculationPatient who underwent a DBS surgery targeting the VIM at Bordeaux University Hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who underwent a DBS surgery targeting the VIM at Bordeaux University Hospital
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- patients who underwent a DBS surgery targeting the VIM for different indications (Parkinson's disease for instance), patients with a poor post-operative efficacy
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 |
|---|---|---|
| Coordinates of active plots and VIM landmarks calculationStimulation 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. | Other | DBS surgery targeting the VIM |
Primary outcome
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.
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 2021.
- 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.
Nejib ZEMZEMI, MD-PhD study chair
Institut National de Recherche en Informatique et en Automatique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Tremor and Deep Brain Stimulation, run by University Hospital, Bordeaux 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 4 inclusion and 1 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 2021. 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?
Euclidian distance between the predicted target and the center of the active contact of the DBS lead (time frame: 6 month after DBS surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2021.