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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01043549
First received: January 4, 2010
Last updated: September 28, 2012
Last verified: December 2011
History of Changes
  Purpose

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 Intervention Phase
Gilles de la Tourette Syndrome
Tics
 Device: rTMS
Device: Sham rTMS
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • Yale global tic severity scale (YTGSS) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 5
Study Start Date: February 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received: January 4, 2010
Last Updated: September 28, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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:
Tourette Syndrome
Tics
Stress, Psychological
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Mental Disorders Diagnosed in Childhood
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 23, 2013