Motor and Premotor Cortex Stimulation for Treatment of Secondary Focal Dystonia With Striato Palliadal Lesion : Evaluation of Safety and Effectiveness (CORDYS)
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.
|Focal Dystonia||Device: Implantation of neurostimulators and their auxiliary components||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, 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|
- 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 ]
- 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 ]
|Study Start Date:||September 2007|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00505323
|Principal Investigator:||Franck DURIF, Pr|