Pallidal Stimulation in Patients With Post-anoxic and Idiopathic Dystonia

Marie-laure Welter

Status and phase: Completed; Phase 2

Conditions: Dystonia

Treatments: Procedure: Deep brain stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT00169338

P020918

Details and patient eligibility

About

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.

Full description

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

Enrollment: 13 patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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13 participants in 2 patient groups, including a placebo group

deep brain stimulation

Experimental group

Description:

Paladin deep brain stimulation

Treatment:

Procedure: Deep brain stimulation

sham deep brain stimulation

Placebo Comparator group

Description:

no stimulation