Validation of the Implantation of a New Electrode for the Treatment of Dystonia (MONOCONTACT)
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|ClinicalTrials.gov Identifier: NCT02509338|
Recruitment Status : Terminated (The medical device arrived at expirationand it was not possible to have new one)
First Posted : July 28, 2015
Last Update Posted : May 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Generalized Dystonia Segmental Dystonia Tardive Dystonia||Device: Electrode deep brain stimulation (Monopolar DBS Lead Model 09064-40cm)||Not Applicable|
Deep brain stimulation (DBS) is a validated therapy for treating dystonia and other movement disorders. The main therapeutical target used for treating dystonic syndromes is the internal globus pallidum (GPi). Given the morphology and the topography of this nucleus and, based on the experience of an efficient therapy by using only one or two contacts out of the available four contacts of the standard DBS lead, we designed two new electrodes, one one contact-electrode and one two contact-electrodes, with the aim to limit side effects related to internal globus pallidum DBS and to provide a more homogeneous electric field around the electrode within the GPi and maintaining the same therapeutical outcome.
The main objective of the trial is to study the technical feasibility of the implantation of a new one contact-electrode (Monopolar DBS Lead Model 09064-40cm) for treating isolated generalized/segmental dystonia or tardive dystonia.
The second main objective of the study is to assess the safety of the implantation of the new device.
The secondary objective is to explore the therapeutical effect of DBS using the new monocontact electrode and to study the electrical field generated around the monocontact electrode within the GPi.
The study is prospective and patients are recruited from a Tertiary Movement Disorders Clinic. Seven subjects will be recruited for the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Validation of an Electrode Internal Globus Pallidum Deep Brain Stimulation Lead Implantation for Treatment of Dystonia|
|Actual Study Start Date :||October 2013|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Electrode deep brain stimulation
Monocontact electrode deep brain stimulation
Device: Electrode deep brain stimulation (Monopolar DBS Lead Model 09064-40cm)
Deep brain stimulation surgery with implantation of one contact-electrode deep brain stimulation electrodes bilaterally in the internal globus pallidum for treating dystonia
- Technical feasibility of new electrode implantation [ Time Frame: One year ]The feasibility of the implantation is evaluated by stereotaxic frame placement, site of incision, burr hole size and location, technique for insertion, connection with the extension cables to the neurostimulator, measure of the impedances, duration of the surgery, MRI control for lead position, comparison of the artefacts of the leads with the artefacts of the standard electrodes.
- Safety of new electrode implantation (evaluated by the occurence of side effects) [ Time Frame: One year ]The safety of the implantation is evaluated by the occurence of side effects after the implatation and along the follow-up.
- clinical effect of deep brain stimulation using one contact-electrodes (Burke Fahn Marsden's dystonia rating scale and the Toronto Western Spasmodic Torticollis Rating Scale) [ Time Frame: One year ]Clinical change as measured by the decrease of the motor and disability of the patient (Burke Fahn Marsden's dystonia rating scale and the Toronto Western Spasmodic Torticollis Rating Scale).
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): NCT02509338
|Montpellier, France, 34295|
|Principal Investigator:||Laura A CIF, MD, PhD||CHRU Montpellier|