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NCT00139308 Clinical Trial

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

Tourette's Syndrome Clinical Trial

Official title:
Pilot Study of Internal Globus Pallidus or Median Centre of the Thalamus High Frequency Stimulation for the Treatment of Patients With Severe Tourette's Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00139308
Other study ID # RBM0008
Secondary ID
Status Completed
Phase Phase 1
First received August 30, 2005
Last updated August 30, 2005

Study information
Verified date August 2005
Source Groupe Hospitalier Pitie-Salpetriere
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• high frequency stimulation

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

Sponsors (2)
Lead Sponsor Collaborator
Groupe Hospitalier Pitie-Salpetriere Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Severity of tics
See also
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