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 : Not yet recruiting
First Posted : November 30, 2018
Last Update Posted : November 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Essential Tremor||Procedure: Opti-VIM targeting in DBS surgery||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Optimization of VIM Targeting in Essential Tremor Surgery|
|Estimated Study Start Date :||December 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
|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.
- 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
- 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.
- 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.
- Surgical complications [ Time Frame: Up to 3 month after DBS surgery ]Onset of infection, hematoma or seizure
- 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.
- 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
- 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
- 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.
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
|Contact: Julien ENGELHARDT, MD||05 56 79 55 77 ext +email@example.com|
|Contact: Olivier BRANCHARD||05 57 82 06 97 ext +firstname.lastname@example.org|
|CHU de Bordeaux||Not yet recruiting|
|Bordeaux, France, 33076|
|Contact: Julien ENGELHARDT, MD 05 56 79 55 77 ext +33 email@example.com|
|Contact: Olivier BRANCHARD 05 57 82 06 97 ext +33 firstname.lastname@example.org|
|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||Not yet recruiting|
|Bron, France, 69500|
|Contact: Patrick MERTENS, MD-PhD email@example.com|
|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|
|Study Chair:||Antoine BENARD, MD||USMR CHU de Bordeaux|