NCT00169338

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
11 days until next milestone

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
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

September 15, 2015

Status Verified

September 1, 2015

Enrollment Period

8.3 years

First QC Date

September 12, 2005

Last Update Submit

September 14, 2015

Conditions

Dystonia

Keywords

Dystoniadeep brain stimulationglobus pallidusPost-anoxic dystonia

Study Arms (2)

deep brain stimulation

EXPERIMENTAL

Paladin deep brain stimulation

Procedure: Deep brain stimulation

sham deep brain stimulation

PLACEBO COMPARATOR

no stimulation

Interventions

Deep brain stimulationPROCEDURE

internal pallidal deep brain stimulation

deep brain stimulation

Eligibility Criteria

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

You may qualify if:

  • Post-anoxic generalised dystonia
  • Idiopathic non-generalised dystonia
  • Disease duration \> 1 year

You may not qualify if:

  • Contraindication to magnetic resonance imaging (MRI)
  • 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

Location

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

September 1, 2005

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

September 15, 2015

Record last verified: 2015-09

Locations

FR(1)