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

Tics Clinical Trial

— rTMSPPCGT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01043549
• Other study ID #: C08-46
• Secondary ID: 2009-A00759-48
• Status: Terminated
• Phase: Phase 2
• First received: January 4, 2010
• Last updated: February 24, 2016
• Start date: February 2010
• Est. completion date: September 2012

Study information

• Verified date: February 2016
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gilles de la Tourette Syndrome
• Syndrome
• Tics
• Tourette Syndrome

Intervention

Device:
• rTMS
Repetitive transcranial stimulation of the posterior parietal cortex
• Sham rTMS
Repetitive transcranial stimulation of the posterior parietal cortex

Locations

Country	Name	City	State
France	Inserm U975	Paris

Sponsors (1)

Lead Sponsor	Collaborator
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	Yale global tic severity scale (YTGSS)		3 months	Yes