Pallidal Stimulation in Patients With Post-anoxic and Idiopathic Dystonia

Phase 2

Completed

• Conditions: Dystonia
• Interventions: Procedure: Deep brain stimulation

• Registration Number: NCT00169338
• Lead Sponsor: Marie-laure Welter

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.

Detailed Description

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

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-14
• Last Update Posted: 2015-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
deep brain stimulation	Deep brain stimulation	Paladin deep brain stimulation

Trial Locations

Locations (1)

Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere; 🇫🇷 Paris, France