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Validation of the Implantation of a New Electrode for the Treatment of Dystonia (MONOCONTACT)

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. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 20, 2015
First Posted Date  ICMJE July 28, 2015
Last Update Posted Date May 22, 2018
Actual Study Start Date  ICMJE October 2013
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2015)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2015)
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Validation of the Implantation of a New Electrode for the Treatment of Dystonia
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Generalized Dystonia
  • Segmental Dystonia
  • Tardive Dystonia
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Electrode deep brain stimulation
Monocontact electrode deep brain stimulation
Intervention: Device: Electrode deep brain stimulation (Monopolar DBS Lead Model 09064-40cm)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 27, 2015)
7
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02509338
Other Study ID Numbers  ICMJE 9053
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University Hospital, Montpellier
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Montpellier
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Laura A CIF, MD, PhD CHRU Montpellier
PRS Account University Hospital, Montpellier
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP