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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00169338
Other study ID # P020918
Secondary ID
Status Completed
Phase Phase 2
First received September 12, 2005
Last updated September 14, 2015
Start date September 2005
Est. completion date January 2014

Study information

Verified date September 2015
Source Groupe Hospitalier Pitie-Salpetriere
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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.


Description:

Evaluate the effect of bilateral pallidal stimulation on the motor disability of patients with post-anoxic generalised dystonia or primary dystonia.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 65 Years
Eligibility Inclusion Criteria:

- Post-anoxic generalised dystonia

- Idiopathic non-generalised dystonia

- Disease duration > 1 year

Exclusion Criteria:

- Contraindication to magnetic resonance imaging (MRI)

- Mini-mental status (MMS) < 24

- Severe psychiatric disorder

Study Design

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


Related Conditions & MeSH terms


Intervention

Procedure:
Deep brain stimulation
internal pallidal deep brain stimulation

Locations

Country Name City State
France Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere Paris

Sponsors (1)

Lead Sponsor Collaborator
Marie-laure Welter

Country where clinical trial is conducted

France, 

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