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

• Sponsor: Groupe Hospitalier Pitie-Salpetriere (Other)
• Overall Status: Completed
• CT.gov ID: NCT00139308
• Collaborator: Institut National de la Santé Et de la Recherche Médicale, France (Other)
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tourette's Syndrome	Device: high frequency stimulation	Phase 1

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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

Outcome Measures

Primary Outcome Measures

1. Severity of tics []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere	Paris		France	75013

Sponsors and Collaborators

• Groupe Hospitalier Pitie-Salpetriere
• Institut National de la Santé Et de la Recherche Médicale, France

Investigators

• Study Director: Yves Agid, MD, PhD, CIC-Pitié-Salpêtrière

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00139308
• Other Study ID Numbers: RBM0008
• First Posted: Aug 31, 2005
• Last Update Posted: Aug 31, 2005
• Last Verified: Aug 1, 2005

• Keywords provided by , ,: Tourette's syndrome; High frequency stimulation; Globus pallidus; Thalamus
• Additional relevant MeSH terms: Tourette Syndrome; Syndrome

Study Results

No Results Posted as of Aug 31, 2005