NCT00478842

Brief Summary

The aim of this study is to evaluate the efficacy and safety of bilateral pallidal stimulation in patients with a severe form of Gilles de la Tourette syndrome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2007

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 25, 2007

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

9.1 years

First QC Date

May 24, 2007

Last Update Submit

February 20, 2017

Conditions

Gilles de la Tourette Syndrome

Keywords

Gilles de la Tourette syndromeDeep brain stimulationGlobus PALLIDUS

Outcome Measures

Primary Outcomes (2)

  • To evaluate the therapeutic effect of the high frequency bilateral stimulation of GPI in severe forms and invalidating MGT, in a protocol randomized as a double blind man in parallel groups.

    during the 44 months

  • The assumption tested is that of the frank improvement (> 60% on scale YGTSS) of the symptoms of the MGT by the bilateral stimulation of GPI in its former part.

    at the end of 44 months

Secondary Outcomes (6)

  • To evaluate time necessary to obtaining the maximum effect and its evolution after this one (maintenance or not of the effect in the course of time)

    during the study

  • To study the effects of the stimulation of GPI in its former part, on the driving tics simple and complex, vocal, the self-mutilations, and the psychopathology of which time, emotions and impulsiveness

    during the 44 months

  • To evaluate the repercussion of this technique on the sociological-professional handicap, operation and the adaptation

    during the 44 months

  • To seek determinants before intervention of the effectiveness of stimulation (determining neurological, psychiatric, neuropsychological, functional)

    during the 44 months

  • To establish correlations between the localization of the studs of stimulation (retiming atlas/IRM) and the symptoms

    during the 44 months

  • +1 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL

Deep brain stimulation

Device: Deep brain stimulation

Interventions

Deep brain stimulationDEVICE

Deep brain stimulation

1

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Severe form of GTS
  • age 18 to 60 years
  • failure of medical treatment (including neuroleptics)

You may not qualify if:

  • Major depression
  • Psychotic symptoms
  • Severe personality disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe hospitalier la Pitié Salpétrière

Paris, 75013, France

Location

Related Publications (2)

  • Houeto JL, Karachi C, Mallet L, Pillon B, Yelnik J, Mesnage V, Welter ML, Navarro S, Pelissolo A, Damier P, Pidoux B, Dormont D, Cornu P, Agid Y. Tourette's syndrome and deep brain stimulation. J Neurol Neurosurg Psychiatry. 2005 Jul;76(7):992-5. doi: 10.1136/jnnp.2004.043273.

    PMID: 15965209RESULT

  • Welter ML, Houeto JL, Thobois S, Bataille B, Guenot M, Worbe Y, Hartmann A, Czernecki V, Bardinet E, Yelnik J, du Montcel ST, Agid Y, Vidailhet M, Cornu P, Tanguy A, Ansquer S, Jaafari N, Poulet E, Serra G, Burbaud P, Cuny E, Aouizerate B, Pollak P, Chabardes S, Polosan M, Borg M, Fontaine D, Giordana B, Raoul S, Rouaud T, Sauvaget A, Jalenques I, Karachi C, Mallet L; STIC study group. Anterior pallidal deep brain stimulation for Tourette's syndrome: a randomised, double-blind, controlled trial. Lancet Neurol. 2017 Aug;16(8):610-619. doi: 10.1016/S1474-4422(17)30160-6. Epub 2017 Jun 20.

    PMID: 28645853DERIVED

MeSH Terms

Conditions

Tourette Syndrome

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTic DisordersMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Marie-Laure WELTER, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2007

First Posted

May 25, 2007

Study Start

November 1, 2007

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

FR(1)