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

NCT01043549 | Terminated Phase 2

• 2 other identifiers: C08-462009-A00759-48
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Gilles de la Tourette Syndrome; Tics

Keywords

Gilles de la Tourette syndrome; Tics; Transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• Yale global tic severity scale (YTGSS)

  3 months

Study Arms (2)

Stimulation

ACTIVE COMPARATOR

Repetitive transcranial stimulation of the posterior parietal cortex

Device: rTMS

Sham stimulation

SHAM COMPARATOR

Device: Sham rTMS

Interventions

rTMS DEVICE

Repetitive transcranial stimulation of the posterior parietal cortex

Stimulation

Sham rTMS DEVICE

Repetitive transcranial stimulation of the posterior parietal cortex

Sham stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Inserm U975

Paris, 75013, France

Location

MeSH Terms

Conditions

Tourette Syndrome; Tics

Condition Hierarchy (Ancestors)

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andreas Hartmann, MD

  Institut National de la Santé Et de la Recherche Médicale, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2010
• First Posted: January 6, 2010
• Study Start: February 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: February 25, 2016

Record last verified: 2016-02

Locations

FR (1)