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

Tourette Syndrome Clinical Trial

— TIC-EEG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03604510
• Other study ID #: CHUBX2016/41
• Status: Completed
• Phase: N/A
• Start date: February 2, 2018
• Est. completion date: March 3, 2020

Study information

• Verified date: April 2020
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 3, 2020
• Est. primary completion date: March 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Syndrome
• Tourette Syndrome

Intervention

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

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electroencephalogram (EEG) signal	24 hours recording of encephalographic activity (EEG) in ecological conditions through Holter EEG.	During 24 hours
Secondary	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
Secondary	Age		Day 0
Secondary	Gender		Day 0
Secondary	Disease duration		Day 0
Secondary	Neurovegetative marker of emotions : RR Interval	Intervals between R waves (RR interval) from the electrocardiogram	During 24 hours
Secondary	Neurovegetative marker of emotions : skin conductance	Skin conductance registered with a Bracelet sensor	During 24 hours
Secondary	MINI (Mini International Neuropsychiatric Interview)		Day 0
Secondary	Montgomery and Asberg Depression Rating Sacle (MADRS) Score		Day 0
Secondary	State Trait Anxiety Inventory (STAI A and B)		Day 0
Secondary	Global Assessment of Functioning Score (Global Assessment of Functioning Scale)		Day 0
Secondary	Yale Global Tic severity score (YGTS)		Day 0
Secondary	ADHD RS rating score (ADHD RS rating Scale)		Day 0
Secondary	Yale Brown Obsessive Compulsive Score (Y-BOCS Scale)		Day 0
Secondary	Obsessive-Compulsive Inventory-Revised Score (OCI-R)		Day 0