Motor and Premotor Cortex Stimulation for Treatment of Secondary Focal Dystonia With Striato Palliadal Lesion : Evaluation of Safety and Effectiveness (CORDYS)
Primary Purpose
Focal Dystonia
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Implantation of neurostimulators and their auxiliary components
Sponsored by
About this trial
This is an interventional treatment trial for Focal Dystonia focused on measuring Cortex stimulation, Focal secondary Dystonia, Effectiveness, Quality of life improvement, Focal dystonias secondary to central grey nuclei lesions
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Evaluation of dystonia by using the validated "Burke Fahn and Marsden (1985)" dystonia rating scale
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.
Full Information
NCT ID
NCT00505323
First Posted
July 20, 2007
Last Updated
July 4, 2014
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT00505323
Brief Title
Motor and Premotor Cortex Stimulation for Treatment of Secondary Focal Dystonia With Striato Palliadal Lesion : Evaluation of Safety and Effectiveness
Acronym
CORDYS
Official Title
Motor and Premotor Cortex Stimulation for Treatment of Secondary Focal Dystonia With Striato Pallidal Lesion : Evaluation of Safety and Effectiveness
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Medtronic
4. Oversight
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focal Dystonia
Keywords
Cortex stimulation, Focal secondary Dystonia, Effectiveness, Quality of life improvement, Focal dystonias secondary to central grey nuclei lesions
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Implantation of neurostimulators and their auxiliary components
Intervention Description
Implantation neurostimulators and their auxiliary components :
Stimulateur KINETRA TM modèle 7428, Electrode Resume II modèle 3587A, Extension kit DBS 7482
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck DURIF, Pr
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Motor and Premotor Cortex Stimulation for Treatment of Secondary Focal Dystonia With Striato Palliadal Lesion : Evaluation of Safety and Effectiveness
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