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

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ClinicalTrials.gov Identifier: NCT03604510
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.


Condition or disease Intervention/treatment Phase
Tourette Syndrome Procedure: Electroencephalographic recordings Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Role of Frontal Cortex in the Pathophysiology of Gilles de la Tourette Syndrome (GTS)
Actual Study Start Date : February 2, 2018
Estimated Primary Completion Date : February 2, 2020
Estimated Study Completion Date : February 2, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Electroencephalogram (EEG) signal [ Time Frame: During 24 hours ]
    24 hours recording of encephalographic activity (EEG) in ecological conditions through Holter EEG.


Secondary Outcome Measures :
  1. Tic occurence [ Time Frame: During 24 hours ]
    Occurence of tic recorded by the patient with a button press connected with a case and automatically recorded with an accelerometers for motor tics.

  2. Age [ Time Frame: Day 0 ]
  3. Gender [ Time Frame: Day 0 ]
  4. Disease duration [ Time Frame: Day 0 ]
  5. Neurovegetative marker of emotions : RR Interval [ Time Frame: During 24 hours ]
    Intervals between R waves (RR interval) from the electrocardiogram

  6. Neurovegetative marker of emotions : skin conductance [ Time Frame: During 24 hours ]
    Skin conductance registered with a Bracelet sensor

  7. MINI (Mini International Neuropsychiatric Interview) [ Time Frame: Day 0 ]
  8. Montgomery and Asberg Depression Rating Sacle (MADRS) Score [ Time Frame: Day 0 ]
  9. State Trait Anxiety Inventory (STAI A and B) [ Time Frame: Day 0 ]
  10. Global Assessment of Functioning Score (Global Assessment of Functioning Scale) [ Time Frame: Day 0 ]
  11. Yale Global Tic severity score (YGTS) [ Time Frame: Day 0 ]
  12. ADHD RS rating score (ADHD RS rating Scale) [ Time Frame: Day 0 ]
  13. Yale Brown Obsessive Compulsive Score (Y-BOCS Scale) [ Time Frame: Day 0 ]
  14. Obsessive-Compulsive Inventory-Revised Score (OCI-R) [ Time Frame: Day 0 ]


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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03604510


Contacts
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Contact: Antoine Daubigney 05 56 79 55 13 antoine.daubigney@chu-bordeaux.fr
Contact: Clotilde Huet 05 57 82 09 54 clotilde.huet@chu-bordeaux.fr

Locations
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France
CHU de Bordeaux Recruiting
Bordeaux, France, 33 076
Contact: Antoine Daubigney    05 56 79 55 13    antoine.daubigney@chu-bordeaux.fr   
Contact: Clotilde Huet    05 57 82 09 54    clotilde.huet@chu-bordeaux.fr   
Sponsors and Collaborators
University Hospital, Bordeaux

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03604510     History of Changes
Other Study ID Numbers: CHUBX2016/41
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tourette Syndrome
Syndrome
Disease
Pathologic Processes
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
Neurodevelopmental Disorders
Mental Disorders