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

NCT ID: NCT01043549

Last Updated: 2016-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gilles de la Tourette Syndrome Tics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Stimulation

Repetitive transcranial stimulation of the posterior parietal cortex

Group Type ACTIVE_COMPARATOR

rTMS

Intervention Type DEVICE

Repetitive transcranial stimulation of the posterior parietal cortex

Sham stimulation

Group Type SHAM_COMPARATOR

Sham rTMS

Intervention Type DEVICE

Repetitive transcranial stimulation of the posterior parietal cortex

Interventions

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rTMS

Repetitive transcranial stimulation of the posterior parietal cortex

Intervention Type DEVICE

Sham rTMS

Repetitive transcranial stimulation of the posterior parietal cortex

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andreas Hartmann, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Inserm U975

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2009-A00759-48

Identifier Type: REGISTRY

Identifier Source: secondary_id

C08-46

Identifier Type: -

Identifier Source: org_study_id

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