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Repetitive Transcranial Magnetic Stimulation of the Posterior Parietal Cortex in Patients Suffering From Gilles de la Tourette Syndrome (rTMSPPCGT)

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ClinicalTrials.gov Identifier: NCT01043549
Recruitment Status : Terminated (lake of efficacy)
First Posted : January 6, 2010
Last Update Posted : February 25, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Repetitive transcranial stimulation (rTMS) of the posterior parietal cortex will be applied daily over five days in adult Gilles de la Tourette patients. This approach aims at reducing premonitory sensations believed to induce tics. Patients will be randomized to an active or placebo (sham) group in a crossover design.

Condition or disease Intervention/treatment Phase
Gilles de la Tourette Syndrome Tics Device: rTMS Device: Sham rTMS Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation of the Posterior Parietal Cortex in Patients Suffering From Gilles de la Tourette Syndrome
Study Start Date : February 2010
Primary Completion Date : September 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Stimulation
Repetitive transcranial stimulation of the posterior parietal cortex
Device: rTMS
Repetitive transcranial stimulation of the posterior parietal cortex
Sham Comparator: Sham stimulation Device: Sham rTMS
Repetitive transcranial stimulation of the posterior parietal cortex


Outcome Measures

Primary Outcome Measures :
  1. Yale global tic severity scale (YTGSS) [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gilles de la Tourette syndrome as defined by DSM IV-R
  • Yale Global Tics Severity Scale (YGTSS) score between 30 et 60
  • Premonitory sensations (" urge to move ")
  • Affiliated to the French social security regime
  • Ability to give informed consent

Exclusion Criteria:

  • rTMS : epilepsy, craniotomy scar, pacemaker or neural stimulator, metal implants or foreign bodies, claustrophobia, pregnancy
  • Cognitive impairment (MMS ≤ 24/30)
  • Axis I disorders according to DSM IV-R : psychosis or history of psychosis, bipolar illness, major depressive disorder, addictions (except to nicotine)
  • Impulse control disorders
  • Other chronic debilitating illnesses
  • Unability to give informed consent
  • Participation in another clinical trial
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01043549


Locations
France
Inserm U975
Paris, France, 75013
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Andreas Hartmann, MD Institut National de la Santé Et de la Recherche Médicale, France
More Information

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01043549     History of Changes
Other Study ID Numbers: C08-46
2009-A00759-48 ( Registry Identifier: IDRCB )
First Posted: January 6, 2010    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Gilles de la Tourette syndrome
Tics
Transcranial magnetic stimulation

Additional relevant MeSH terms:
Syndrome
Tourette Syndrome
Disease
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders