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Multimodal Electrophysiological Study of Cortico-subcortical Biomarkers of Tics in Tourette Syndrome

Key facts

Who runs it
University Hospital, Bordeaux
Where
France1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
10 people, planned
Started
17 Feb 2025
Expected to end
17 Feb 2027
Type of study
Interventional
Treatments tested
  • Multimodal electrophysiological recordings
Record updated
3 April 2025

Who can take part

Age
16 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • Patient at least 16 years old
  • Disabling and drug-resistant Tourette's syndrome
  • Receiving deep brain stimulation treatment with implantation of the PERCEPT™ Device as part of their medical management
  • Normal brain MRI
  • Subject affiliated or beneficiary of a social security system
  • Free and informed consent of the patient and, for minors, of the minor and at least one parental authority

Who cannot take part

  • Major depressive syndrome (Beck Depression Inventory (BDI-II) > 20)
  • MRI showing significant brain atrophy or significant hyperintensities
  • Pregnant or nursing mothers
  • Person unable to give personal consent
  • Person subject to a legal protection measure (curatorship, guardianship) or placed under court protection
  • Patient included in another research protocol with an interdiction of participation to another research or in an exclusion period

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Tourette syndrome (TS) is a complex neurodevelopmental disorder characterized by the occurrence of involuntary movements (motor tics) and vocalizations (phonic tics). The onset of TS is usually in childhood, and the prevalence of TS is estimated between 0.3 and 0.9% before the age of 18, decreasing progressively after that age. Most patients also suffer from associated psychiatric comorbidities (ADHD, OCD, mood disorders). Although the cause of TS remains unknown, the preferred hypothesis is the interaction of predisposing genetic factors and precipitating environmental factors (perinatal accidents, infectious diseases). From a pathophysiological point of view, it is widely demonstrated by structural, electrophysiological studies, functional neuroimaging, as well as by different animal models, that dysfunctions of the cortico-striato-pallido-thalamo-cortical loops (responsible for the regulation of movements, cognitive processes, and emotions) play a major role in the genesis of tics. Deep brain stimulation (DBS) treatment can be proposed as an invasive therapy in patients with severe TS resistant to usual treatments (psychotherapy, pharmacological treatments). In a well-selected population of drug-resistant patients, DBS allows an estimated overall improvement of 30 to 50% in the YGTSS score. The deep brain stimulation method currently used in TS is based on continuous (24/7) and undifferentiated stimulation (fixed electrical intensity). This stimulation paradigm, devoid of adaptability to the patient's symptoms, could be at the origin of undesirable effects (related to the modulation of physiological signals), of a sub-optimal efficiency, or of an unnecessary overuse of the stimulator's capacities (battery depletion). The development of new deep brain stimulation paradigms ("closed-loop stimulation"), allowing the identification of pathological neuronal activity and the dynamic adaptation of stimulation parameters to these neuronal signals, requires reliable and reproducible pathological biomarker, correlated with the occurrence of tics.

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However, in TS, electrophysiological abnormalities are still not well characterized, and most of the work published on the subject were based on intraoperative recordings and needs to be confirmed on recordings at a distance from the surgery before its potential use in closed-loop stimulation paradigms. Indeed, during the first weeks after surgery, different factors tend to modify the electrophysiological signals.

Several questions arise at the end of this healing period:

* Are these pathological oscillations (distinct from the brain oscillations induced by physiological voluntary movement) still detectable weeks after the surgery? * What are the temporal dynamics of these oscillations around a tic? * What is the spatial topography of these oscillations within the GPi? * Is there a strong inter-individual variability? * How are changes in cortical activity associated with these subcortical oscillations? * Are the modulations of pallidal activity alone sufficient to predict the occurrence of a tic? Thus, our study aims to define precisely the cortico-subcortical activity concomitant with the occurrence of a tic, and to identify reliable and reproducible biomarker(s) associated with tics in TS.

In order to specify these biomarker(s), their temporal correlation to tic occurrence, their spatial distribution, as well as the dynamics and cortico-subcortical coherence of the identified abnormalities, we propose a prospective study on 10 patients with severe and drug-resistant TS, treated by bi-pallidal deep brain stimulation as part of routine care (no device implantation as part of the research).

An evaluation of pallidal LFP synchronized with a high-resolution video-electroencephalography recording (128 to 256 sensors) will be performed at a distance (M+[3-48]) from surgery, in order to determine the variations in pallidal and electroencephalographic activity surrounding the occurrence of tics. A control condition with voluntary ("tic-like") movement will be carried out in a second time, to distinguish the modifications related to the voluntary movement from those related to the occurrence of a tic. A reconstruction of the electrode positioning will be performed using the LeadDBS pipeline, and individual and group analyses will be performed to specify the mapping of pathological oscillations within the pallidum and throughout the cerebral cortex.

The group in the trial

  • Patient with Tourette's syndromeTreatment being tested

    Patient with Tourette's syndrome receiving deep brain stimulation treatment with implantation of the PERCEPT™ device as part of their medical management.

    Treatment: Multimodal electrophysiological recordings

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
3 April 2025