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Completed

NCT Number: NCT03604510

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electroencephalographic recordings

Procedure

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

Primary outcomes

  1. Electroencephalogram (EEG) signal

    Time frame: During 24 hours

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: TIC-EEG

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 27, 2018
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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