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Optimization of VIM Targeting in Essential Tremor Surgery (Opti-VIM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03760406
Recruitment Status : Recruiting
First Posted : November 30, 2018
Last Update Posted : May 5, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Essential Tremor Procedure: Opti-VIM targeting in DBS surgery Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Optimization of VIM Targeting in Essential Tremor Surgery
Actual Study Start Date : March 18, 2018
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Severe essential tremor treated by DBS Procedure: Opti-VIM targeting in DBS 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change of Fahn-Tolosa-Marin (FTM) scale score [ Time Frame: Before and 3 month after DBS surgery ]
    Scale global range : min=0 / max=160 Higher values represent worse tremor


Secondary Outcome Measures :
  1. Accelerometry recordings : spectral analysis [ Time Frame: Before and 3 month after DBS surgery ]
    Accelerometry recordings at the pre-inclusion visit and at 3 months after surgery in ON and OFF-stimulation conditions with spectral analysis.

  2. Accelerometry recordings : calculation of the total accelerometry power [ Time Frame: Before and 3 month after DBS surgery ]
    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.

  3. Surgical complications [ Time Frame: Up to 3 month after DBS surgery ]
    Onset of infection, hematoma or seizure

  4. Device complications and dysfunction [ Time Frame: Up to 3 month after DBS surgery ]
    rupture or displacement of electrode, pain at the stimulation box implantation site or along the subcutaneous cable if they require further intervention, infection.

  5. Neurostimulation-related side effects [ Time Frame: Up to 3 month after DBS surgery ]
    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

  6. Quality of life: change of modified Parkinson's Disease Questionnaire-39 (mPDQ-39) scale score [ Time Frame: Before and 3 month after DBS surgery ]
    Adaptation of Parkinson's Disease Questionnaire-39 to essential tremor Scale global range : min=0 / max=156 Higher values represent worse Quality of life

  7. Coordinates of active contacts [ Time Frame: 3 month after DBS surgery ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Depression (Beck Depression Inventory scale > 20)
  • Contra-indication to surgery or general anesthesia
  • Cerebral atrophy on MRI scan
  • Pregnant or breastfeeding women
Contacts and Locations
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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): NCT03760406


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
CHU de Bordeaux 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   
Principal Investigator: Julien ENGELHARDT, MD         
Sub-Investigator: Emmanuel CUNY, MD-PhD         
Sub-Investigator: Pierre BURBAUD, MD         
Sub-Investigator: Dominique GUEHL, MD-PhD         
Sub-Investigator: Nathalie PERRIERE, MD         
Hospices Civils de Lyon Recruiting
Bron, France, 69500
Contact: Patrick MERTENS, MD-PhD       patrick.mertens@chu-lyon.fr   
Principal Investigator: Patrick MERTENS, MD-PhD         
Sub-Investigator: Gustavo POLO, MD         
Sub-Investigator: Emile SIMON, MD         
Sub-Investigator: Stéphane THOBOIS, MD-PhD         
Sub-Investigator: Teodor DANAILA, MD         
Sub-Investigator: Chloé LAURENCIN, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Study Chair: Antoine BENARD, MD USMR CHU de Bordeaux
More Information
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03760406    
Other Study ID Numbers: CHUBX 2018/32
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: May 5, 2022
Last Verified: May 2022

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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:
Essential Tremor
Deep brain stimulation
Ventro-intermediate nucleus of the thalamus
Targeting
Asleep surgery
Additional relevant MeSH terms:
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Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
 Nervous System Diseases
Movement Disorders
Central Nervous System Diseases