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CompletedNCT00169338Updated Sep 15, 2015

Pallidal Stimulation in Patients With Post-anoxic and Idiopathic Dystonia

A Phase 2 interventional study of Deep brain stimulation in Dystonia, sponsored by Marie-laure Welter. Completed at 1 site in France. Open to participants aged 15 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-09-15.

Sponsored by Marie-laure Welter · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
15 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Dystonia

Keywords

  • Dystonia
  • deep brain stimulation
  • globus pallidus
  • Post-anoxic dystonia
03

In context

Dystonia

319 studies on the registry are indexed under Dystonia; 56 are open to participants now.

This study's enrollment of 13 is below the median of 32 across 181 interventional studies indexed under Dystonia.

Browse Dystonia studies →

Lead sponsor

Marie-laure Welter is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Post-anoxic generalised dystonia
  • Idiopathic non-generalised dystonia
  • Disease duration > 1 year

Exclusion criteria

Exclusion Criteria:

  • Contraindication to magnetic resonance imaging (MRI)
  • Mini-mental status (MMS) \< 24
  • Severe psychiatric disorder
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    deep brain stimulation

    Paladin deep brain stimulation

    Procedure: Deep brain stimulation

  • Placebo comparator
    sham deep brain stimulation

    no stimulation

Interventions

  • ProcedureDeep brain stimulation

    internal pallidal deep brain stimulation

06

Study locations

1 site
  • Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere
    Paris, France
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00169338
Lead sponsor
Marie-laure Welter
Responsible party
Marie-laure Welter (MD, PhD, Groupe Hospitalier Pitie-Salpetriere) — Sponsor-investigator
First posted
Sep 15, 2005
Start date
Sep 2005
Primary completion
Jan 2014
Completion
Jan 2014
Last update
Sep 15, 2015

Study contacts

Marie Vidailhet, MD, PhD
study director · Hôpital Saint-Antoine
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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