Role of Frontal Cortex in the Pathophysiology of Gilles de la Tourette Syndrome (GTS) (TIC-EEG)
Primary Purpose
Tourette Syndrome
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Electroencephalographic recordings
Sponsored by
About this trial
This is an interventional health services research trial for Tourette Syndrome
Eligibility Criteria
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
Sites / Locations
- CHU de Bordeaux
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Electroencephalographic recordings
Arm Description
Electroencephalographic recordings
Outcomes
Primary Outcome Measures
Electroencephalogram (EEG) signal
24 hours recording of encephalographic activity (EEG) in ecological conditions through Holter EEG.
Secondary Outcome Measures
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.
Age
Gender
Disease duration
Neurovegetative marker of emotions : RR Interval
Intervals between R waves (RR interval) from the electrocardiogram
Neurovegetative marker of emotions : skin conductance
Skin conductance registered with a Bracelet sensor
MINI (Mini International Neuropsychiatric Interview)
Montgomery and Asberg Depression Rating Sacle (MADRS) Score
State Trait Anxiety Inventory (STAI A and B)
Global Assessment of Functioning Score (Global Assessment of Functioning Scale)
Yale Global Tic severity score (YGTS)
ADHD RS rating score (ADHD RS rating Scale)
Yale Brown Obsessive Compulsive Score (Y-BOCS Scale)
Obsessive-Compulsive Inventory-Revised Score (OCI-R)
Full Information
NCT ID
NCT03604510
First Posted
April 5, 2018
Last Updated
April 4, 2020
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT03604510
Brief Title
Role of Frontal Cortex in the Pathophysiology of Gilles de la Tourette Syndrome (GTS)
Acronym
TIC-EEG
Official Title
Role of Frontal Cortex in the Pathophysiology of Gilles de la Tourette Syndrome (GTS)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 2, 2018 (Actual)
Primary Completion Date
March 3, 2020 (Actual)
Study Completion Date
March 3, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electroencephalographic recordings
Arm Type
Experimental
Arm Description
Electroencephalographic recordings
Intervention Type
Procedure
Intervention Name(s)
Electroencephalographic recordings
Intervention Description
24 hours of electroencephalographic recordings (EEG-Holter) of prefrontal activity of Tourette's syndrome (TS) patients in ecological conditions.
Primary Outcome Measure Information:
Title
Electroencephalogram (EEG) signal
Description
24 hours recording of encephalographic activity (EEG) in ecological conditions through Holter EEG.
Time Frame
During 24 hours
Secondary Outcome Measure Information:
Title
Tic occurence
Description
Occurence of tic recorded by the patient with a button press connected with a case and automatically recorded with an accelerometers for motor tics.
Time Frame
During 24 hours
Title
Age
Time Frame
Day 0
Title
Gender
Time Frame
Day 0
Title
Disease duration
Time Frame
Day 0
Title
Neurovegetative marker of emotions : RR Interval
Description
Intervals between R waves (RR interval) from the electrocardiogram
Time Frame
During 24 hours
Title
Neurovegetative marker of emotions : skin conductance
Description
Skin conductance registered with a Bracelet sensor
Time Frame
During 24 hours
Title
MINI (Mini International Neuropsychiatric Interview)
Time Frame
Day 0
Title
Montgomery and Asberg Depression Rating Sacle (MADRS) Score
Time Frame
Day 0
Title
State Trait Anxiety Inventory (STAI A and B)
Time Frame
Day 0
Title
Global Assessment of Functioning Score (Global Assessment of Functioning Scale)
Time Frame
Day 0
Title
Yale Global Tic severity score (YGTS)
Time Frame
Day 0
Title
ADHD RS rating score (ADHD RS rating Scale)
Time Frame
Day 0
Title
Yale Brown Obsessive Compulsive Score (Y-BOCS Scale)
Time Frame
Day 0
Title
Obsessive-Compulsive Inventory-Revised Score (OCI-R)
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33 076
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Role of Frontal Cortex in the Pathophysiology of Gilles de la Tourette Syndrome (GTS)
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