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

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00505323
First received: July 20, 2007
Last updated: July 4, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Focal Dystonia
Device: Implantation of neurostimulators and their auxiliary components
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Motor and Premotor Cortex Stimulation for Treatment of Secondary Focal Dystonia With Striato Pallidal Lesion : Evaluation of Safety and Effectiveness

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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. [ Time Frame: before the chirurgical intervention and 2, 5, 6, 9 and 13 months after ] [ Designated as safety issue: Yes ]

Enrollment: 5
Study Start Date: September 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Implantation of neurostimulators and their auxiliary components

    Implantation neurostimulators and their auxiliary components :

    Stimulateur KINETRA TM modèle 7428, Electrode Resume II modèle 3587A, Extension kit DBS 7482

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505323

Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Medtronic
Investigators
Principal Investigator: Franck DURIF, Pr
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00505323     History of Changes
Other Study ID Numbers: 2007-A00100-53, PHRC N 2007 DURIF
Study First Received: July 20, 2007
Last Updated: July 4, 2014
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Cortex stimulation
Focal secondary Dystonia
Effectiveness
Quality of life improvement
Focal dystonias secondary to central grey nuclei lesions

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Neoplasm Metastasis
Central Nervous System Diseases
Dyskinesias
Movement Disorders
Neoplasms
Neoplastic Processes
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014