We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00505323
First Posted: July 23, 2007
Last Update Posted: July 8, 2014
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.
Collaborator:
Medtronic
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
July 20, 2007
July 23, 2007
July 8, 2014
September 2007
June 2011   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00505323 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Motor and Premotor Cortex Stimulation for Treatment of Secondary Focal Dystonia With Striato Palliadal Lesion : Evaluation of Safety and Effectiveness
Motor and Premotor Cortex Stimulation for Treatment of Secondary Focal Dystonia With Striato Pallidal Lesion : Evaluation of Safety and Effectiveness

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.

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
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Focal Dystonia
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

Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
June 2011
June 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00505323
2007-A00100-53
PHRC N 2007 DURIF
Not Provided
Not Provided
Not Provided
University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
Medtronic
Principal Investigator: Franck DURIF, Pr
University Hospital, Clermont-Ferrand
July 2014

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