Pallidal Stimulation in Patients With Idiopathic Generalised Dystonia - Full Text View

Pallidal Stimulation in Patients With Idiopathic Generalised Dystonia

This study is currently recruiting participants.
Verified by Groupe Hospitalier Pitie-Salpetriere, September 2005

Sponsors and Collaborators:	Groupe Hospitalier Pitie-Salpetriere Délégation Régionale à la Recherche Clinique
Information provided by:	Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier:	NCT00169403

Purpose

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.

Condition	Intervention	Phase
Dystonia	Procedure: Deep brain stimulation	Phase III

Genetics Home Reference related topics:

early-onset primary dystonia

MedlinePlus related topics:

Dystonia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Eligibility

Ages Eligible for Study:	15 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Idiopathic generalised dystonia
Pallidal stimulation

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169403

Contacts


Contact: Marie Vidailhet, MD, PhD	33-142161950	marie.vidailhet@sat.ap-hop-paris.fr

Contact: Marie-Laure Welter, MD	33-142161950	marie-laure.welter@psl.aphp.fr

Locations


France
	Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere	Recruiting
	Paris, France
	Contact: Marie-Laure Welter, MD 33-142161950 marie-laure.welter@psl.aphp.fr
	Principal Investigator: Marie Vidailhet, MD, PhD

Sponsors and Collaborators

Groupe Hospitalier Pitie-Salpetriere

Délégation Régionale à la Recherche Clinique

Investigators


Study Director:	Marie Vidailhet, MD, PhD	Hôpital Saint-Antoine

More Information

Publications of Results:

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.

Study ID Numbers:	P000201
First Received:	September 12, 2005
Last Updated:	August 28, 2007
ClinicalTrials.gov Identifier:	NCT00169403
Health Authority:	France: Ministry of Health

Keywords provided by Groupe Hospitalier Pitie-Salpetriere:

Idiopathic dystonia

deep brain stimulation

globus pallidus

generalised Idiopathic dystonia

Study placed in the following topic categories:

Dystonic Disorders

Signs and Symptoms

Movement Disorders

Central Nervous System Diseases

Neurologic Manifestations

Dystonia

Dyskinesias

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on September 05, 2008