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

Focal Dystonia Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders
• Focal Dystonia

• NCT number: NCT00505323
• Study type: Interventional
• Source: University Hospital, Clermont-Ferrand
• Status: Completed
• Phase: Phase 1
• Start date: September 2007
• Completion date: June 2011