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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00169403
Other study ID # P000201
Secondary ID
Status Recruiting
Phase Phase 3
First received September 12, 2005
Last updated August 28, 2007

Study information

Verified date September 2005
Source Groupe Hospitalier Pitie-Salpetriere
Contact Marie Vidailhet, MD, PhD
Phone 33-142161950
Email marie.vidailhet@sat.ap-hop-paris.fr
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 65 Years
Eligibility Inclusion Criteria:

- Idiopathic generalised dystonia

- Pallidal stimulation

Exclusion Criteria:

- Mini-mental status (MMS) < 24

- Severe psychiatric disorder

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Deep brain stimulation


Locations

Country Name City State
France Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere Paris

Sponsors (2)

Lead Sponsor Collaborator
Groupe Hospitalier Pitie-Salpetriere Délégation Régionale à la Recherche Clinique

Country where clinical trial is conducted

France, 

References & Publications (1)

Vidailhet M, Vercueil L, Houeto JL, Krystkowiak P, Benabid AL, Cornu P, Lagrange C, Tézenas du Montcel S, Dormont D, Grand S, Blond S, Detante O, Pillon B, Ardouin C, Agid Y, Destée A, Pollak P; French Stimulation du Pallidum Interne dans la Dystonie (SPI — View Citation

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