High Frequency Stimulation of the GPi or Thalamus in Tourette's Syndrome

NCT ID: NCT00139308

Last Updated: 2005-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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Tourette's syndrome is a disabling neuropsychiatric disorder with major psychosocial consequences in some patients. The pathophysiology is still unknown. Some data suggest an dysfunction of limbic circuits in basal ganglia. The aim of this study is to evaluate the effect of high frequency stimulation of the internal part of the globus pallidus and/or parafascicular-median centre of the thalamus, two structures implicated in the limbic circuit, in patients with severe Tourette's syndrome.

Detailed Description

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Conditions

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Tourette's Syndrome

Keywords

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Tourette's syndrome High frequency stimulation Globus pallidus Thalamus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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high frequency stimulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Tourette's syndrome (DSM IV)
* inducing a disability in the social and personal life
* No improvement with medical treatment
* Severe self suffering

Exclusion Criteria

* Cognitive impairment (MMS \< 24)
* Depression
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

Groupe Hospitalier Pitie-Salpetriere

OTHER

Sponsor Role lead

Principal Investigators

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Yves Agid, MD, PhD

Role: STUDY_DIRECTOR

CIC-Pitié-Salpêtrière

Locations

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Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere

Paris, , France

Site Status

Countries

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France

References

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Welter ML, Mallet L, Houeto JL, Karachi C, Czernecki V, Cornu P, Navarro S, Pidoux B, Dormont D, Bardinet E, Yelnik J, Damier P, Agid Y. Internal pallidal and thalamic stimulation in patients with Tourette syndrome. Arch Neurol. 2008 Jul;65(7):952-7. doi: 10.1001/archneur.65.7.952.

Reference Type DERIVED
PMID: 18625864 (View on PubMed)

Other Identifiers

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RBM0008

Identifier Type: -

Identifier Source: org_study_id