Validation of the Implantation of a New Electrode for the Treatment of Dystonia

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Brief Title

Validation of the Implantation of a New Electrode for the Treatment of Dystonia

Official Title

Validation of an Electrode Internal Globus Pallidum Deep Brain Stimulation Lead Implantation for Treatment of Dystonia

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.
    

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 Type

Interventional


Primary Outcome

Technical feasibility of new electrode implantation

Secondary Outcome

 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)

Condition

Generalized Dystonia

Intervention

Electrode deep brain stimulation (Monopolar DBS Lead Model 09064-40cm)

Study Arms / Comparison Groups

 Electrode deep brain stimulation
Description:  Monocontact electrode deep brain stimulation

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

7

Start Date

October 2013

Completion Date

December 2016

Primary Completion Date

December 2016

Eligibility 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
      

Gender

All

Ages

18 Years - 64 Years

Accepts Healthy Volunteers

No

Contacts

Laura A CIF, MD, PhD, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02509338

Organization ID

9053


Responsible Party

Sponsor

Study Sponsor

University Hospital, Montpellier


Study Sponsor

Laura A CIF, MD, PhD, Principal Investigator, CHRU Montpellier


Verification Date

May 2018