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Recruiting NCT06050369

Objective Characterizatoion of Repetitive Behaviors

No phase Interventional OCD Tic Disorders Gilles de la Tourette Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EEG, MRI.
Who it may be relevant to
Registry conditions: OCD, Tic Disorders, Gilles de la Tourette Syndrome. Basic parameters: 15 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Actimetric and Electrophysiological Analyses of Repetitive Behaviors (Tics and Compulsions)

Overview

Introduction: Repetitive behaviors (RB) constitute a broad range of symptoms across different psychiatric/neurologic disorders. The most famous are stereotypies (found in autism), compulsions (found in obsessive-compulsive-disorder, OCD) and tics (found in Gilles de la Tourette syndrome, GTS). For some patients, it is sometime difficult to distinguish the nature of the repetitive behaviors presented, however this distinction is crucial in order to chose the appropriate treatment. Aim: In our study, the investigators will try to define electrophysiological and accelerometric marker of both OCD and tics to allow objective distinction between both tics and compulsions. Method: Subjects: Both OCD and GTS patients will be recruited, 25 patients in each group. Protocol: our study protocol will involve two step: a step in laboratory, another step at patient home. * first step: both patients group will be recorded through a high density EEG and a portative EEG while doing a task of symptom provocation. Then they will get an anatomical MRI for source recontruction. Finally, the patients will have to mimic their symptom while wearing an accelerometer (a smartwatch). * second step: both patient groups will be recorded at home through a portative EEG while tagging their symptom through a smartwatch (also used for accelerometry). After the recording, the patients will keep the smartwatch for 2 weeks, still tagging their sympoms (compulsions or tics).

Interventions

  • Device EEG
    Recording, from the scalp, the electrophysiological activity of the brain.
  • Device MRI
    Get the anatomical shape of the brain.

Primary outcome measures

  • modification of power (μV2) in EEG frequencies before compulsions in Obsessive-Compulsive Disorder patients [Time frame: one year]
  • modification of power (μV2) in EEG frequencies before tics in Gilles de la Tourette patients [Time frame: one year]
Secondary outcome measures (4)
  • Difference in power (μV2) in EEG frequencies between obsessive-compulsive disorder patients and Gilles de la Tourette patients [Time frame: One year and a half]
  • percentage (%) of compulsions and tics detected by accelerometer [Time frame: One year and a half]
  • Correlation of EEG frequency power (arbitrary units) detected before compulsions and scores get with clinical scales (Y-BOCS) [Time frame: One year and a half]
  • Correlation between number of compulsions detected by accelerometer and Y-BOCS scores get by obsessive-compulsive patients [Time frame: One year and a half]

Eligibility criteria

Inclusion criteria

  • To be more of 15 years old or less than 65 years old
  • To suffer from OCD and/or GTS (depressive, anxious and attention deficit hyperactivity disorder (ADHD) comorbidities are accepted)
  • To be registered to the french social security (or something equivalent)
  • To give written consent to participate to the research
  • To have contraception for women participants (or to not have any sexual activity)

Exclusion criteria

  • Patients with any other psychiatric disorders than those mentioned in the inclusion criteria
  • Patients with any other neurological disorder than GTS
  • Patients who are not able to take decisions for themselves
  • Pregnant women
  • Patients not allowed to get MRI due to contraindication
  • Patients not speaking french

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

France · 3 centers
  • Hôpital Albert Chenevier — Créteil
  • Hôpital Henri Mondor — Créteil
  • Hôpital Pitié Salpêtrière — Paris

Identifiers

NCT: NCT06050369 · C21-48 · 2022-A01332-41

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗