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

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.

Study Overview

• Status: Completed
• Conditions: Tourette Syndrome
• Intervention / Treatment: Procedure: Electroencephalographic recordings

Detailed Description

Gilles de la Tourette syndrome (GTS) is a childhood-onset disorder characterized by the presence of multiple motor tics and at least one vocal tic often associated with psychiatric co-morbidity. The expression of tics range from brief, recurrent and non-rhythmic motor or vocal actions (simple tics) to complex motor or vocal sequences (complex tics). The pathophysiology of tics is not yet fully understood. Recent imaging data suggest that the pattern of functional connectivity in cortico-basal ganglia networks is disrupted in GTS patients and could reflect a defect in brain maturation. However, regions involved in the immediate genesis of tics remains unknown since it is difficult to capture on line the cortical changes associated with tic generation using imaging techniques due to moving artefacts. Moreover, tics are much more frequent in everyday life conditions than in the artificial conditions of a laboratory. The aim is to study cortical activity changes occurring before tic occurrence by using long duration recording of encephalographic activity (EEG) in ecological conditions through Holter EEG techniques (24h recordings). Recordings will be performed in 15 patients with a severe form of Tourette's syndromes. EEG changes will be correlated to event markers, voluntary monitored by patients or automatically recorded (accelerometers for motor tics). EEG epoch centered on tics will be compared to similar epochs without tics. The occurrence of tics will also be correlated with neurovegetative markers of emotions such as RR interval ECG variability and skin resistivity changes. The ultimate goal of this project is to define a potential therapeutic target of tics for chronic cortical stimulation.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33 076
    • CHU de Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 58 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electroencephalographic recordings	Procedure: Electroencephalographic recordings; 24 hours of electroencephalographic recordings (EEG-Holter) of prefrontal activity of Tourette's syndrome (TS) patients in ecological conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electroencephalogram (EEG) signal	24 hours recording of encephalographic activity (EEG) in ecological conditions through Holter EEG.	During 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tic occurence	Occurence of tic recorded by the patient with a button press connected with a case and automatically recorded with an accelerometers for motor tics.	During 24 hours
Age		Day 0
Gender		Day 0
Disease duration		Day 0
Neurovegetative marker of emotions : RR Interval	Intervals between R waves (RR interval) from the electrocardiogram	During 24 hours
Neurovegetative marker of emotions : skin conductance	Skin conductance registered with a Bracelet sensor	During 24 hours
MINI (Mini International Neuropsychiatric Interview)		Day 0
Montgomery and Asberg Depression Rating Sacle (MADRS) Score		Day 0
State Trait Anxiety Inventory (STAI A and B)		Day 0
Global Assessment of Functioning Score (Global Assessment of Functioning Scale)		Day 0
Yale Global Tic severity score (YGTS)		Day 0
ADHD RS rating score (ADHD RS rating Scale)		Day 0
Yale Brown Obsessive Compulsive Score (Y-BOCS Scale)		Day 0
Obsessive-Compulsive Inventory-Revised Score (OCI-R)		Day 0

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2018
• Primary Completion (Actual): March 3, 2020
• Study Completion (Actual): March 3, 2020

Study Registration Dates

• First Submitted: April 5, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 4, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Heredodegenerative Disorders, Nervous System; Neurodevelopmental Disorders; Tic Disorders; Syndrome; Tourette Syndrome
• Other Study ID Numbers: CHUBX2016/41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No