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

Sponsor
University Hospital, Bordeaux (Other)
Overall Status
Completed
CT.gov ID
NCT03604510
Collaborator
(none)
14
1
1
25
0.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Electroencephalographic recordings
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
N/A
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 :
Feb 2, 2018
Actual Primary Completion Date :
Mar 3, 2020
Actual Study Completion Date :
Mar 3, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Electroencephalogram (EEG) signal [During 24 hours]

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

Secondary Outcome Measures

  1. Tic occurence [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 [Day 0]

  3. Gender [Day 0]

  4. Disease duration [Day 0]

  5. Neurovegetative marker of emotions : RR Interval [During 24 hours]

    Intervals between R waves (RR interval) from the electrocardiogram

  6. Neurovegetative marker of emotions : skin conductance [During 24 hours]

    Skin conductance registered with a Bracelet sensor

  7. MINI (Mini International Neuropsychiatric Interview) [Day 0]

  8. Montgomery and Asberg Depression Rating Sacle (MADRS) Score [Day 0]

  9. State Trait Anxiety Inventory (STAI A and B) [Day 0]

  10. Global Assessment of Functioning Score (Global Assessment of Functioning Scale) [Day 0]

  11. Yale Global Tic severity score (YGTS) [Day 0]

  12. ADHD RS rating score (ADHD RS rating Scale) [Day 0]

  13. Yale Brown Obsessive Compulsive Score (Y-BOCS Scale) [Day 0]

  14. Obsessive-Compulsive Inventory-Revised Score (OCI-R) [Day 0]

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Bordeaux Bordeaux France 33 076

Sponsors and Collaborators

  • University Hospital, Bordeaux

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT03604510
Other Study ID Numbers:
  • CHUBX2016/41
First Posted:
Jul 27, 2018
Last Update Posted:
Apr 7, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2020