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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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Brief Summary:
The main objective of the trial is to study the technical feasibility of the implantation of a new electrode Monocontact deep brain stimulation electrode in dystonia.

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

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age superior to 18 years and inferior to 65 years
  • Generalized or segmental isolated dystonia or tardive dystonia
  • Diagnosis is based on history, clinical examination, check-up without abnormalities and normal brain MRI allowing exclusion of secondary and degenerative dystonias
  • Unsufficient response to pharmacological treatment (improvement < 30/% on clinical dystonia scales)
  • No comorbidity interfering with general anesthesia, or representing contraindication for neurosurgical procedure or with the follow-up during the trial
  • Consent of the patient
  • Insurance affiliation
  • Follow-up possible for 12 months
  • Available insurance for the operated patient

Exclusion Criteria:

  • No possibility for clinical follow-up
  • Acquired dystonia except for tardive dystonia
  • MRI or generalized anesthesia contraindicated
  • Anticoagulant treatment or antiaggregant treatment
  • Pregnancy
  • Ongoing participation to another clinical trial
  • Guardianship or Trusteeship
  • Person deprived of liberty
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): NCT02509338


Locations
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France
Chru Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Laura A CIF, MD, PhD CHRU Montpellier
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02509338    
Other Study ID Numbers: 9053
First Posted: July 28, 2015    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Dystonia
Dystonic Disorders
Tardive Dyskinesia
Dyskinesias
Neurologic Manifestations
 Nervous System Diseases
Movement Disorders
Central Nervous System Diseases
Dyskinesia, Drug-Induced