NCT04449068

Brief Summary

Within an ongoing deep brain stimulation (DBS) program for Tourette syndrome (TS) at the Department of Neurology, Pitié-Salpêtrière Hospital, Paris/France, the investigator team plans to evaluate patients pre-operatively and then at one year intervals post-operatively until the 5-year mark has been achieved. The investigator team will investigate tic severity, psychiatric co-morbidities, quality of life, and neuropsychological measures.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
123mo left

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Jan 2021Jun 2036

First Submitted

Initial submission to the registry

June 23, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 26, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

January 12, 2021

Completed
15.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2036

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2036

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

15.4 years

First QC Date

June 23, 2020

Last Update Submit

March 4, 2026

Conditions

Tourette Syndrome

Keywords

bilateral deep brain stimulationTourette syndrome,

Outcome Measures

Primary Outcomes (1)

  • Measure the severity of tics

    Measure the severity of tics, determined by the YGTSS-R (Yale Global Tic Severity Scale score - revised) . The overall score is between 0 (no TICS) and 100 (severity in TICS) therefore a score decrease is expected .

    Month 60

Study Arms (1)

Evaluation of patients with Tourette's Gilles Syndrome

Neurological and neuropsychological evaluations of patients with Tourette's Gilles syndrome treated with high frequency bilateral stimulation of the anterior part of the internal pallid globus

Other: Neurological and neuropsychological Follow-up after deep brain stimulationDevice: EEG recordings

Interventions

Neurological and neuropsychological Follow-up after deep brain stimulationOTHER

Investigation of tic severity, psychiatric co-morbidities, quality of life, and neuropsychologcial measures until the 5-year after deep brain stimulation (DBS)

Evaluation of patients with Tourette's Gilles Syndrome
EEG recordingsDEVICE

EEG recordings at 2 visits (V1 and V2)

Evaluation of patients with Tourette's Gilles Syndrome

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with Tourette syndrome eligible for bilateral deep brain stimulation of the anterior internal pallid globus

You may qualify if:

  • Tourette syndrome severe and drug-resistant eligible for bilateral deep brain stimulation
  • Person who voluntarily and knowledgeably agreed to participate in the study

You may not qualify if:

  • Non affiliation to a French social security system (recipient or assign) excluding AME

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIC Neurosciences, GH Pitié-Salpêtrière

Paris, 75013, France

RECRUITING

Related Publications (2)

  • 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: 28645853BACKGROUND

  • Welter ML, Houeto JL, Worbe Y, Diallo MH, Hartmann A, Tezenas du Montcel S, Ansquer S, Thobois S, Fontaine D, Rouaud T, Cuny E, Karachi C, Mallet L; STIC study group. Long-term effects of anterior pallidal deep brain stimulation for tourette's syndrome. Mov Disord. 2019 Apr;34(4):586-588. doi: 10.1002/mds.27645. Epub 2019 Feb 20. No abstract available.

    PMID: 30788865BACKGROUND

MeSH Terms

Conditions

Tourette Syndrome

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

Central Study Contacts

Andreas HARTMANN, MD

CONTACT

1 42 16 13 16andreas.hartmann@aphp.fr

Yulia Worbe, MD,PHD

CONTACT

142161316yulia.worbe@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2020

First Posted

June 26, 2020

Study Start

January 12, 2021

Primary Completion (Estimated)

June 12, 2036

Study Completion (Estimated)

June 12, 2036

Last Updated

March 6, 2026

Record last verified: 2026-03

Locations

FR(1)