NCT00139308

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

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

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2005

Completed
Last Updated

August 31, 2005

Status Verified

August 1, 2005

First QC Date

August 30, 2005

Last Update Submit

August 30, 2005

Conditions

Tourette's Syndrome

Keywords

Tourette's syndromeHigh frequency stimulationGlobus pallidusThalamus

Outcome Measures

Primary Outcomes (1)

  • Severity of tics

Interventions

high frequency stimulationDEVICE

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Cognitive impairment (MMS \< 24)
  • Depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere

Paris, 75013, France

Location

Related Publications (1)

  • 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.

    PMID: 18625864DERIVED

MeSH Terms

Conditions

Tourette Syndrome

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTic DisordersMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurodevelopmental DisordersMental Disorders

Study Officials

  • Yves Agid, MD, PhD

    CIC-Pitié-Salpêtrière

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 30, 2005

First Posted

August 31, 2005

Last Updated

August 31, 2005

Record last verified: 2005-08

Locations

FR(1)