Role of Frontal Cortex in the Pathophysiology of Gilles de la Tourette Syndrome (GTS)

NCT03604510 | Completed

• 1 other identifier: CHUBX2016/41
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Tourette's syndrome (TS) is a debilitating and severe syndrome whose pathophysiology remains unclear. In order to precise the cortical regions involved in the generation of tics, investigators will realize an electroencephalogram (EEG) recording in the frontal cortex of TS patients in ecological conditions (EEG-holter). Activity changes will be correlated with event markers of tics and neurovegetative parameters. Statistical analyses will be compared between epochs of EEG recording with tics and without tics. The aim is to define the cortical regions involved in the genesis of tics in order to consider new targets for cortical stimulation.

Conditions

Tourette Syndrome

Outcome Measures

Primary Outcomes (1)

• Electroencephalogram (EEG) signal

  24 hours recording of encephalographic activity (EEG) in ecological conditions through Holter EEG.

  During 24 hours

Secondary Outcomes (14)

• Tic occurence

  During 24 hours

• Age

  Day 0

• Gender

  Day 0

• Disease duration

  Day 0

• Neurovegetative marker of emotions : RR Interval

  During 24 hours

Study Arms (1)

Electroencephalographic recordings

EXPERIMENTAL

Electroencephalographic recordings

Procedure: Electroencephalographic recordings

Interventions

Electroencephalographic recordings PROCEDURE

24 hours of electroencephalographic recordings (EEG-Holter) of prefrontal activity of Tourette's syndrome (TS) patients in ecological conditions.

Electroencephalographic recordings

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Tourette's syndrome since at least 2 years
• Lack of psychiatric comorbidity of axis 1 (depression)
• Y-YSGT score \> 20
• Social insurance in accordance with the french law

You may not qualify if:

• Epilepsia
• Patient with an implanted medical device
• Severe mental or somatic disease
• Risk of suicide,
• Pregnant or breast feeding women
• Patient under "curatelle" or "tutelle"
• Patient hospitalized
• no social insurance

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33 076, France

Location

MeSH Terms

Conditions

Tourette Syndrome

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: July 27, 2018
• Study Start: February 2, 2018
• Primary Completion: March 3, 2020
• Study Completion: March 3, 2020
• Last Updated: April 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)