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Motor and Premotor Cortex Stimulation for Treatment of Secondary Focal Dystonia With Striato Palliadal Lesion : Evaluation of Safety and Effectiveness (CORDYS)

Primary Purpose

Focal Dystonia

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Implantation of neurostimulators and their auxiliary components
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Focal Dystonia focused on measuring Cortex stimulation, Focal secondary Dystonia, Effectiveness, Quality of life improvement, Focal dystonias secondary to central grey nuclei lesions

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age : >18 years and < 65 years
  • Evolution time of dystonia > 1 year
  • Clinical stability of dystonia = 1 year
  • Secondary dystonia due to a focal lesion (vascular or anoxic) of central grey nuclei
  • Inefficiency of others treatments (anticholinergic, benzodiazepine, neuroleptique, botulinum toxin, etc.)
  • Stability of treatment >3 months
  • Agreement of patients
  • Affiliation to social security

Exclusion Criteria:

  • Significant heart vascular disease; significant respiratory, metabolic, renal or hepatic diseases
  • Significant clinical and biological anomalies
  • Disease or treatment in favour in bleeding
  • Sever cognitive disorders
  • Psychiatric evolutionary pathology
  • Counter-indication during inclusion examination
  • Chirurgical counter-indication
  • Pregnant women ou women who nurse
  • Person who participate to an other study

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Evaluation of dystonia by using the validated "Burke Fahn and Marsden (1985)" dystonia rating scale

    Secondary Outcome Measures

    Evaluation of spasticity (Ashworth), of akinesy (Tapping score), of pain (EVA test), of quality of life (SF 36 scale) and of undesirable events.

    Full Information

    First Posted
    July 20, 2007
    Last Updated
    July 4, 2014
    Sponsor
    University Hospital, Clermont-Ferrand
    Collaborators
    Medtronic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00505323
    Brief Title
    Motor and Premotor Cortex Stimulation for Treatment of Secondary Focal Dystonia With Striato Palliadal Lesion : Evaluation of Safety and Effectiveness
    Acronym
    CORDYS
    Official Title
    Motor and Premotor Cortex Stimulation for Treatment of Secondary Focal Dystonia With Striato Pallidal Lesion : Evaluation of Safety and Effectiveness
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2007 (undefined)
    Primary Completion Date
    June 2011 (Actual)
    Study Completion Date
    June 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Clermont-Ferrand
    Collaborators
    Medtronic

    4. Oversight

    5. Study Description

    Brief Summary
    Dystonia is a neurological movement disorder in which sustained muscle contractions cause twisting and repetitive movements or abnormal postures. This disease is very heterogeneous and can have many causes. Current treatments (drugs, pallidal stimulation) improve primary generalized dystonias; however they are ineffective for focal dystonias following brain damage. Cortex stimulation is a present and effective technique used in the treatment of chronic pain and could represent an interesting strategy to treat focal dystonias. This is the aim of the present study.
    Detailed Description
    Pilot study included 6 centres (Clermont-Ferrand, Bordeaux, Paris, Créteil, Lyon and Grenoble) Study progress : 3 months to 1 month before chirurgical intervention : selection of patient that could be included in the protocol. 15 days to 8 days before chirurgical intervention : inclusion visit. Operating phase : under anaesthesia, implantation of the neurostimulator and its components, and adjustment of stimulation parameters. 1 month after chirurgical intervention : checking that all is fine (detection of undesirable events) 2 months to 5 months after chirurgical intervention: randomization (double blind): the stimulator is put on position On or OFF 5 months after chirurgical intervention : Stimulators of all patients are stopped for one month whatever the group they belong. 6 months to 9 months after chirurgical intervention: Stimulatiors are put on position On or OFF (cross over with the first period). 9 months to 13 months after chirurgical intervention: Stimulators of all patients are started for four months whatever the group they belong. 13 months after chirurgical intervention : study end

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Focal Dystonia
    Keywords
    Cortex stimulation, Focal secondary Dystonia, Effectiveness, Quality of life improvement, Focal dystonias secondary to central grey nuclei lesions

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    5 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Implantation of neurostimulators and their auxiliary components
    Intervention Description
    Implantation neurostimulators and their auxiliary components : Stimulateur KINETRA TM modèle 7428, Electrode Resume II modèle 3587A, Extension kit DBS 7482
    Primary Outcome Measure Information:
    Title
    Evaluation of dystonia by using the validated "Burke Fahn and Marsden (1985)" dystonia rating scale
    Time Frame
    before the chirurgical intervention and 2, 5, 6, 9 and 13 months after
    Secondary Outcome Measure Information:
    Title
    Evaluation of spasticity (Ashworth), of akinesy (Tapping score), of pain (EVA test), of quality of life (SF 36 scale) and of undesirable events.
    Time Frame
    before the chirurgical intervention and 2, 5, 6, 9 and 13 months after

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age : >18 years and < 65 years Evolution time of dystonia > 1 year Clinical stability of dystonia = 1 year Secondary dystonia due to a focal lesion (vascular or anoxic) of central grey nuclei Inefficiency of others treatments (anticholinergic, benzodiazepine, neuroleptique, botulinum toxin, etc.) Stability of treatment >3 months Agreement of patients Affiliation to social security Exclusion Criteria: Significant heart vascular disease; significant respiratory, metabolic, renal or hepatic diseases Significant clinical and biological anomalies Disease or treatment in favour in bleeding Sever cognitive disorders Psychiatric evolutionary pathology Counter-indication during inclusion examination Chirurgical counter-indication Pregnant women ou women who nurse Person who participate to an other study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Franck DURIF, Pr
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Motor and Premotor Cortex Stimulation for Treatment of Secondary Focal Dystonia With Striato Palliadal Lesion : Evaluation of Safety and Effectiveness

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