Pallidal Stimulation in Patients With Post-anoxic and Idiopathic Dystonia

NCT ID: NCT00169338

Last Updated: 2015-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2014-01-31

Brief Summary

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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

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

Conditions

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Dystonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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deep brain stimulation

Paladin deep brain stimulation

Group Type EXPERIMENTAL

Deep brain stimulation

Intervention Type PROCEDURE

internal pallidal deep brain stimulation

sham deep brain stimulation

no stimulation

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Deep brain stimulation

internal pallidal deep brain stimulation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marie-laure Welter

OTHER

Sponsor Role lead

Responsible Party

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Marie-laure Welter

MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Marie Vidailhet, MD, PhD

Role: STUDY_DIRECTOR

Hôpital Saint-Antoine

Locations

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Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere

Paris, , France

Site Status

Countries

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France

Other Identifiers

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P020918

Identifier Type: -

Identifier Source: org_study_id

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