NCT00169403

Brief Summary

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

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

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

August 29, 2007

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

August 28, 2007

Conditions

Dystonia

Keywords

Idiopathic dystoniadeep brain stimulationglobus pallidusgeneralised Idiopathic dystonia

Interventions

Deep brain stimulationPROCEDURE

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic generalised dystonia
  • Pallidal stimulation

You may not qualify if:

  • Mini-mental status (MMS) \< 24
  • Severe psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere

Paris, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 15689584RESULT

MeSH Terms

Conditions

Dystonia

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Marie Vidailhet, MD, PhD

    Hôpital Saint-Antoine

    STUDY DIRECTOR

Central Study Contacts

Marie Vidailhet, MD, PhD

CONTACT

33-142161950marie.vidailhet@sat.ap-hop-paris.fr

Marie-Laure Welter, MD

CONTACT

33-142161950marie-laure.welter@psl.aphp.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Last Updated

August 29, 2007

Record last verified: 2005-09

Locations

FR(1)