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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03604510
Recruitment Status : Completed
First Posted : July 27, 2018
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Tracking Information
First Submitted Date  ICMJE April 5, 2018
First Posted Date  ICMJE July 27, 2018
Last Update Posted Date April 7, 2020
Actual Study Start Date  ICMJE February 2, 2018
Actual Primary Completion Date March 3, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2018)
Electroencephalogram (EEG) signal [ Time Frame: During 24 hours ]
24 hours recording of encephalographic activity (EEG) in ecological conditions through Holter EEG.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2019)
  • 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.
  • Age [ Time Frame: Day 0 ]
  • Gender [ Time Frame: Day 0 ]
  • Disease duration [ Time Frame: Day 0 ]
  • Neurovegetative marker of emotions : RR Interval [ Time Frame: During 24 hours ]
    Intervals between R waves (RR interval) from the electrocardiogram
  • Neurovegetative marker of emotions : skin conductance [ Time Frame: During 24 hours ]
    Skin conductance registered with a Bracelet sensor
  • MINI (Mini International Neuropsychiatric Interview) [ Time Frame: Day 0 ]
  • Montgomery and Asberg Depression Rating Sacle (MADRS) Score [ Time Frame: Day 0 ]
  • State Trait Anxiety Inventory (STAI A and B) [ Time Frame: Day 0 ]
  • Global Assessment of Functioning Score (Global Assessment of Functioning Scale) [ Time Frame: Day 0 ]
  • Yale Global Tic severity score (YGTS) [ Time Frame: Day 0 ]
  • ADHD RS rating score (ADHD RS rating Scale) [ Time Frame: Day 0 ]
  • Yale Brown Obsessive Compulsive Score (Y-BOCS Scale) [ Time Frame: Day 0 ]
  • Obsessive-Compulsive Inventory-Revised Score (OCI-R) [ Time Frame: Day 0 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2018)
  • 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.
  • Age [ Time Frame: Day 0 ]
  • Gender [ Time Frame: Day 0 ]
  • Disease duration [ Time Frame: Day 0 ]
  • Neurovegetative marker of emotions : RR Interval [ Time Frame: During 24 hours ]
    Intervals between R waves (RR interval) from the electrocardiogram
  • Neurovegetative marker of emotions : skin conductance [ Time Frame: During 24 hours ]
    Skin conductance registered with a Bracelet sensor
  • MINI (Mini International Neuropsychiatric Interview) [ Time Frame: Day 0 ]
  • Montgomery and Asberg Depression Rating Sacle (MADRS) [ Time Frame: Day 0 ]
  • State Trait Anxiety Inventory (STAI A and B) [ Time Frame: Day 0 ]
  • Global Assessment of Functioning Scale [ Time Frame: Day 0 ]
  • Yale Global Tic severity scale (YGTS) [ Time Frame: Day 0 ]
  • ADHD RS rating scale [ Time Frame: Day 0 ]
  • Yale Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: Day 0 ]
  • Obsessive-Compulsive Inventory-Revised (OCI-R) [ Time Frame: Day 0 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of Frontal Cortex in the Pathophysiology of Gilles de la Tourette Syndrome (GTS)
Official Title  ICMJE Role of Frontal Cortex in the Pathophysiology of Gilles de la Tourette Syndrome (GTS)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Tourette Syndrome
Intervention  ICMJE Procedure: Electroencephalographic recordings
24 hours of electroencephalographic recordings (EEG-Holter) of prefrontal activity of Tourette's syndrome (TS) patients in ecological conditions.
Study Arms  ICMJE Experimental: Electroencephalographic recordings
Electroencephalographic recordings
Intervention: Procedure: Electroencephalographic recordings
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 4, 2020)
14
Original Estimated Enrollment  ICMJE
 (submitted: July 19, 2018)
15
Actual Study Completion Date  ICMJE March 3, 2020
Actual Primary Completion Date March 3, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03604510
Other Study ID Numbers  ICMJE CHUBX2016/41
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Bordeaux
Study Sponsor  ICMJE University Hospital, Bordeaux
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Bordeaux
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP