Pallidal Stimulation in Patients With Idiopathic Generalised Dystonia

NCT ID: NCT00169403

Last Updated: 2007-08-29

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

UNKNOWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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Pallidal stimulation is effective in patients with generalised idiopathic dystonia. The aim of this study is to:

1. evaluate the efficacy and safety of this treatment in patients with idiopathic generalised dystonia, 3 years after surgery and
2. assess the recurrence of the motor symptoms after the switch off.

Detailed Description

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Conditions

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Dystonia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Deep brain stimulation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Idiopathic generalised dystonia
* Pallidal stimulation

Exclusion Criteria

* 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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University Hospital, Tours

OTHER

Sponsor Role collaborator

Groupe Hospitalier Pitie-Salpetriere

OTHER

Sponsor Role lead

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 RECRUITING

Countries

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France

Central Contacts

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Marie Vidailhet, MD, PhD

Role: CONTACT

33-142161950

Marie-Laure Welter, MD

Role: CONTACT

33-142161950

Facility Contacts

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Marie-Laure Welter, MD

Role: primary

33-142161950

References

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Vidailhet M, Vercueil L, Houeto JL, Krystkowiak P, Benabid AL, Cornu P, Lagrange C, Tezenas du Montcel S, Dormont D, Grand S, Blond S, Detante O, Pillon B, Ardouin C, Agid Y, Destee A, Pollak P; French Stimulation du Pallidum Interne dans la Dystonie (SPIDY) Study Group. Bilateral deep-brain stimulation of the globus pallidus in primary generalized dystonia. N Engl J Med. 2005 Feb 3;352(5):459-67. doi: 10.1056/NEJMoa042187.

Reference Type RESULT
PMID: 15689584 (View on PubMed)

Other Identifiers

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P000201

Identifier Type: -

Identifier Source: org_study_id