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

Primary Purpose

Gilles de la Tourette Syndrome, Tics

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
rTMS
Sham rTMS
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gilles de la Tourette Syndrome focused on measuring Gilles de la Tourette syndrome, Tics, Transcranial magnetic stimulation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Inserm U975

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Stimulation

Sham stimulation

Arm Description

Repetitive transcranial stimulation of the posterior parietal cortex

Outcomes

Primary Outcome Measures

Yale global tic severity scale (YTGSS)

Secondary Outcome Measures

Full Information

First Posted
January 4, 2010
Last Updated
February 24, 2016
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT01043549
Brief Title
Repetitive Transcranial Magnetic Stimulation of the Posterior Parietal Cortex in Patients Suffering From Gilles de la Tourette Syndrome
Acronym
rTMSPPCGT
Official Title
Repetitive Transcranial Magnetic Stimulation of the Posterior Parietal Cortex in Patients Suffering From Gilles de la Tourette Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Why Stopped
lake of efficacy
Study Start Date
February 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gilles de la Tourette Syndrome, Tics
Keywords
Gilles de la Tourette syndrome, Tics, Transcranial magnetic stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stimulation
Arm Type
Active Comparator
Arm Description
Repetitive transcranial stimulation of the posterior parietal cortex
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
rTMS
Intervention Description
Repetitive transcranial stimulation of the posterior parietal cortex
Intervention Type
Device
Intervention Name(s)
Sham rTMS
Intervention Description
Repetitive transcranial stimulation of the posterior parietal cortex
Primary Outcome Measure Information:
Title
Yale global tic severity scale (YTGSS)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Hartmann, MD
Organizational Affiliation
Institut National de la Santé Et de la Recherche Médicale, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inserm U975
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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