Trial record 11 of 163 for:
dystonia
Motor and Premotor Cortex Stimulation for Treatment of Secondary Focal Dystonia With Striato Palliadal Lesion : Evaluation of Safety and Effectiveness (CORDYS)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by University Hospital, Clermont-Ferrand.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University Hospital, Clermont-Ferrand
Collaborator:
Medtronic
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00505323
First received: July 20, 2007
Last updated: January 31, 2008
Last verified: January 2008
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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 ]
| Estimated Enrollment: | 12 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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
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 More Information
No publications provided
| Responsible Party: | CHU Clermont-Ferrand, Neurology center |
| 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: | January 31, 2008 |
| 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 Dyskinesias Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Movement Disorders Central Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013