Pallidal Stimulation in Patients With Post-Anoxic and Idiopathic Dystonia
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Groupe Hospitalier Pitie-Salpetriere.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Groupe Hospitalier Pitie-Salpetriere
Collaborator:
Délégation Régionale à la Recherche Clinique
Information provided by:
Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier:
NCT00169338
First received: September 12, 2005
Last updated: August 27, 2007
Last verified: September 2005
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 12, 2005 | ||||||||
| Last Updated Date | August 27, 2007 | ||||||||
| Start Date ICMJE | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00169338 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Pallidal Stimulation in Patients With Post-Anoxic and Idiopathic Dystonia | ||||||||
| Official Title ICMJE | Not Provided | ||||||||
| Brief Summary | Bilateral pallidal stimulation is effective in the treatment of patients with generalised idiopathic dystonia. The aim of this study is to evaluate the efficacy of bilateral pallidal stimulation in patients with post-anoxic generalised dystonia or non-generalised primary dystonia. |
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| Detailed Description | Evaluate the effect of bilateral pallidal stimulation on the motor disability of patients with post-anoxic generalised dystonia or primary dystonia. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE | Dystonia | ||||||||
| Intervention ICMJE | Procedure: Deep brain stimulation | ||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | Not Provided | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 15 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00169338 | ||||||||
| Other Study ID Numbers ICMJE | P020918 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | Groupe Hospitalier Pitie-Salpetriere | ||||||||
| Collaborators ICMJE | Délégation Régionale à la Recherche Clinique | ||||||||
| Investigators ICMJE |
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| Information Provided By | Groupe Hospitalier Pitie-Salpetriere | ||||||||
| Verification Date | September 2005 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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