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Pallidal Stimulation in Patients With Idiopathic Generalised Dystonia

Primary Purpose

Dystonia

Status

Unknown status

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Deep brain stimulation

About this trial

This is an interventional treatment trial for Dystonia focused on measuring Idiopathic dystonia, deep brain stimulation, globus pallidus, generalised Idiopathic dystonia

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Idiopathic generalised dystonia Pallidal stimulation Exclusion Criteria: Mini-mental status (MMS) < 24 Severe psychiatric disorder

Sites / Locations

Centre d'Investigation Clinique-Hôpital Pitié-SalpetriereRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00169403

First Posted

September 12, 2005

Last Updated

August 28, 2007

Sponsor

Groupe Hospitalier Pitie-Salpetriere

Collaborators

University Hospital, Tours

1. Study Identification

Unique Protocol Identification Number

NCT00169403

Brief Title

Pallidal Stimulation in Patients With Idiopathic Generalised Dystonia

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Unknown status

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Groupe Hospitalier Pitie-Salpetriere

Collaborators

University Hospital, Tours

4. Oversight

5. Study Description

Brief Summary

Pallidal stimulation is effective in patients with generalised idiopathic dystonia. The aim of this study is to: evaluate the efficacy and safety of this treatment in patients with idiopathic generalised dystonia, 3 years after surgery and assess the recurrence of the motor symptoms after the switch off.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dystonia

Keywords

Idiopathic dystonia, deep brain stimulation, globus pallidus, generalised Idiopathic dystonia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Deep brain stimulation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Idiopathic generalised dystonia Pallidal stimulation Exclusion Criteria: Mini-mental status (MMS) < 24 Severe psychiatric disorder

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marie Vidailhet, MD, PhD

Phone

33-142161950

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

First Name & Middle Initial & Last Name or Official Title & Degree

Marie-Laure Welter, MD

Phone

33-142161950

marie-laure.welter@psl.aphp.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marie Vidailhet, MD, PhD

Organizational Affiliation

Hôpital Saint-Antoine

Official's Role

Study Director

Facility Information:

Facility Name

Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere

City

Paris

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marie-Laure Welter, MD

Phone

33-142161950

marie-laure.welter@psl.aphp.fr

First Name & Middle Initial & Last Name & Degree

Marie Vidailhet, MD, PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

15689584

Citation

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.

Results Reference

result

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Pallidal Stimulation in Patients With Idiopathic Generalised Dystonia

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