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Essential TremorOpti-VIMNCT03760406

Optimization of VIM Targeting in Essential Tremor Surgery

A study testing Opti-VIM targeting in DBS surgery in people with Essential Tremor, run by University Hospital, Bordeaux at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Deep brain stimulation (DBS) for essential tremor is based on the intermedius ventralis nucleus of the thalamus (VIM) stimulation. This structure is however very difficult to target, as it remains invisible on imaging. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Essential Tremor
What is being tested?
Opti-VIM targeting in DBS surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
2 sitesFrance
Study dates
18 Mar 2019to 29 Aug 2023
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Severe essential tremor despite the optimal medical management
  • Age between 18 and 75 years
  • Normal MRI scan
  • Mattis Dementia Rating Scale (MDRS) score ≥ 130
  • Affiliation to the social security
  • Signed informed consent

Who cannot join

  • Depression (Beck Depression Inventory scale > 20)
  • Contra-indication to surgery or general anesthesia
  • Cerebral atrophy on MRI scan
  • Pregnant or breastfeeding women

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • CHU de Bordeaux

    Bordeaux, 33076

  • Hospices Civils de Lyon

    Bron, 69500

Other trials in France

About this study

Deep brain stimulation (DBS) for essential tremor is based on the intermedius ventralis nucleus of the thalamus (VIM) stimulation. This structure is however very difficult to target, as it remains invisible on imaging. The current procedure based on awake surgery with clinical and electrophysiological testings has several limitations that lead us to develop a probabilistic model to locate precisely the target. This study aims to show that asleep DBS surgery based on this new targeting method leads to at least the same clinical results than the classical procedure.

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 on 1,5 tesla MRI (the only magnetic field available for stereotactic surgery). The target coordinates currently used are based on stereotactic atlases or mean coordinates from retrospective series. They are so imprecise that intra-operative clinical testing and micro-electrode recordings are mandatory to locate the exact position of the VIM. This procedure is long lasting, requires that the patient is awake, and increases the risk of intracerebral haemorrhage and nosocomial infections. Furthermore, some patients are not improved despite a DBS lead implanted in the electrophysiologically and clinically defined target. To overcome these limitations, investigators developed a probabilistic model based on data extracted from imaging of patients with particularly good outcomes after DBS surgery. This machine-learning model allows calculating to coordinates of the VIM according to the position of radio-anatomical landmarks with a mean precision of 1,65mm.

The aim of this study is to validate this new targeting method on a prospective cohort of patients. DBS surgery will be performed under general anaesthesia, without intra-operative clinical and electrophysiological testing, with a surgical robot and under CT-scan guidance (O-Arm ©).

Neurostimulation device programming will be performed as usual. Patients' tremor and quality of life will be evaluated pre and post-operatively at 3 months, according to the Fahn-Tolosa-Marin (FTM) scale and with an accelerometry recording (for tremor) and with the mPDQ-39 scale for quality of life. Surgical complications and side effects related to neurostimulation will be gathered all along the follow-up.

Being tested
Opti-VIM targeting in DBS surgery
Keywords
Essential Tremor, Deep brain stimulation, Ventro-intermediate nucleus of the thalamus, Targeting, Asleep surgery
Medical subject headings
Essential Tremor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Opti-VIM targeting in DBS surgeryProcedure or surgery

    DBS surgery will be performed under general anaesthesia, without intra-operative clinical and electrophysiological testing, with a surgical robot and under CT-scan guidance (O-Arm ©). The VIM coordinates will be calculated with the probabilistic model that have been developed.

Study groups in NCT03760406
Study groupRoleWhat they receive
Severe essential tremor treated by DBSExperimentalNot described
Receives: Procedure: Opti-VIM targeting in DBS surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of Fahn-Tolosa-Marin (FTM) scale score

    Scale global range : min=0 / max=160 Higher values represent worse tremor

    Measured: Before and 3 month after DBS surgery

Secondary outcomes (7)

  1. Accelerometry recordings : spectral analysis

    Accelerometry recordings at the pre-inclusion visit and at 3 months after surgery in ON and OFF-stimulation conditions with spectral analysis.

    Measured: Before and 3 month after DBS surgery

  2. Accelerometry recordings : calculation of the total accelerometry power

    Accelerometry recordings at the pre-inclusion visit and at 3 months after surgery in ON and OFF-stimulation conditions with calculation of the total accelerometry power.

    Measured: Before and 3 month after DBS surgery

  3. Surgical complications

    Onset of infection, hematoma or seizure

    Measured: Up to 3 month after DBS surgery

  4. Device complications and dysfunction

    rupture or displacement of electrode, pain at the stimulation box implantation site or along the subcutaneous cable if they require further intervention, infection.

    Measured: Up to 3 month after DBS surgery

  5. Neurostimulation-related side effects

    Onset of dysarthria and ataxia assessed by the items 1 to 4 of the Scale for Assessment and Rating of Ataxia (SARA), ataxia assessed by a posturometry analysis, paresthesia, muscular contractions

    Measured: Up to 3 month after DBS surgery

  6. Quality of life: change of modified Parkinson's Disease Questionnaire-39 (mPDQ-39) scale score

    Adaptation of Parkinson's Disease Questionnaire-39 to essential tremor Scale global range : min=0 / max=156 Higher values represent worse Quality of life

    Measured: Before and 3 month after DBS surgery

  7. Coordinates of active contacts

    Coordinates of active contacts (i.e; the contact with the best effect on tremor without side effects) These coordinates (x, y, z) are obtained by merging the images of the 3-month postoperative scanner with the images of the preoperative MRI.

    Measured: 3 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.

  1. First posted30 Nov 2018
  2. Study start18 Mar 2019
  3. Primary completion29 Aug 2023
  4. Study completion29 Aug 2023

Resources

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03760406
Sponsor's protocol ID
CHUBX 2018/32
Other IDs
2018-A02754-51
Acronym
Opti-VIM
Status last verified
Feb 2025
First submitted
26 Nov 2018
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Engelhardt J, Simon E, Zemzemi N, Dallies-Labourdette C, Courtin E, Sitta R, Benard A, Branchard O, Goillandeau M, Laurencin C, Gervais-Bernard H, Caire C, Thobois S, Tourdias T, Munsch F, Guehl D, Cuny E. Enhancing Asleep Deep Brain Stimulation Targeting for Essential Tremor Using Machine Learning: The OPTIVIM Phase 2 Study. Neurosurgery. 2026 Aug 1;99(2):324-333. doi: 10.1227/neu.0000000000003870. Epub 2025 Dec 5.

    PubMed 41626878

Questions about this trial

What is this clinical trial studying?

A study testing Opti-VIM targeting in DBS surgery in people with Essential Tremor, run by University Hospital, Bordeaux at 2 sites 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 4 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 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Change of Fahn-Tolosa-Marin (FTM) scale score (time frame: Before and 3 month after DBS 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 NCT03760406, which also lists 1 linked publication.

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 2 Jun 2026.

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