Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00505323
Status:
COMPLETED
Last Update Posted:
2014-07-08
First Post:
2007-07-20
Brief Title:
Motor and Premotor Cortex Stimulation for Treatment of Secondary Focal Dystonia With Striato Palliadal Lesion Evaluation of Safety and Effectiveness
Sponsor:
University Hospital Clermont-Ferrand
Organization:
University Hospital Clermont-Ferrand
Study Overview
Official Title:
Motor and Premotor Cortex Stimulation for Treatment of Secondary Focal Dystonia With Striato Pallidal Lesion Evaluation of Safety and Effectiveness
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CORDYS
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PHRC N 2007 DURIF | None | None | None |