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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00139308 |
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Date of registration:
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30/08/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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High Frequency Stimulation of the GPi or Thalamus in Tourette's Syndrome
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Scientific title:
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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 |
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Date of first enrolment:
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October 2004 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00139308 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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France
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Contacts
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Name:
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Yves Agid, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CIC-Pitié-Salpêtrière |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tourette's Syndrome
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Intervention(s)
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Device: high frequency stimulation
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Primary Outcome(s)
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Severity of tics
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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