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Pallidal Stimulation in Patients With Post-anoxic and Idiopathic Dystonia

Primary Purpose

Dystonia

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Deep brain stimulation

About this trial

This is an interventional treatment trial for Dystonia focused on measuring Dystonia, deep brain stimulation, globus pallidus, Post-anoxic dystonia

Eligibility Criteria

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

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

Sites / Locations

Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

deep brain stimulation

sham deep brain stimulation

Arm Description

Paladin deep brain stimulation

no stimulation

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00169338

First Posted

September 12, 2005

Last Updated

September 14, 2015

Sponsor

Marie-laure Welter

1. Study Identification

Unique Protocol Identification Number

NCT00169338

Brief Title

Pallidal Stimulation in Patients With Post-anoxic and Idiopathic Dystonia

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Marie-laure Welter

4. Oversight

5. Study Description

Brief 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.

Detailed Description

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

6. Conditions and Keywords

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

Dystonia

Keywords

Dystonia, deep brain stimulation, globus pallidus, Post-anoxic dystonia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

deep brain stimulation

Arm Type

Experimental

Arm Description

Paladin deep brain stimulation

Arm Title

sham deep brain stimulation

Arm Type

Placebo Comparator

Arm Description

no stimulation

Intervention Type

Procedure

Intervention Name(s)

Deep brain stimulation

Intervention Description

internal pallidal 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

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

12. IPD Sharing Statement

Learn more about this trial

Pallidal Stimulation in Patients With Post-anoxic and Idiopathic Dystonia

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