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Clinical Trials/NCT03604510
NCT03604510
Completed
Not Applicable

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

University Hospital, Bordeaux1 site in 1 country14 target enrollmentFebruary 2, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tourette Syndrome
Sponsor
University Hospital, Bordeaux
Enrollment
14
Locations
1
Primary Endpoint
Electroencephalogram (EEG) signal
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2, 2018
End Date
March 3, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Bordeaux
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Electroencephalogram (EEG) signal

Time Frame: During 24 hours

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

Secondary Outcomes

  • Obsessive-Compulsive Inventory-Revised Score (OCI-R)(Day 0)
  • Tic occurence(During 24 hours)
  • Disease duration(Day 0)
  • Neurovegetative marker of emotions : RR Interval(During 24 hours)
  • MINI (Mini International Neuropsychiatric Interview)(Day 0)
  • State Trait Anxiety Inventory (STAI A and B)(Day 0)
  • Age(Day 0)
  • Montgomery and Asberg Depression Rating Sacle (MADRS) Score(Day 0)
  • Gender(Day 0)
  • Neurovegetative marker of emotions : skin conductance(During 24 hours)
  • Yale Global Tic severity score (YGTS)(Day 0)
  • ADHD RS rating score (ADHD RS rating Scale)(Day 0)
  • Global Assessment of Functioning Score (Global Assessment of Functioning Scale)(Day 0)
  • Yale Brown Obsessive Compulsive Score (Y-BOCS Scale)(Day 0)

Study Sites (1)

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