Clinical trial NCT06050369: Objective Characterizatoion of Repetitive Behaviors
Official title: Actimetric and Electrophysiological Analyses of Repetitive Behaviors (tics and Compulsions)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: OCD
Tic Disorders
Gilles De La Tourette Syndrome
Keywords: Electrophysiology
Electroencephalogram
EEG
Accelerometer
Biomarker
Symptom provocation
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2023-09-22
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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).


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

Primary outcomes:
measure: modification of power (μV2) in EEG frequencies before compulsions in Obsessive-Compulsive Disorder patients
timeFrame: one year
measure: modification of power (μV2) in EEG frequencies before tics in Gilles de la Tourette patients
timeFrame: one year
Secondary outcomes:
measure: Difference in power (μV2) in EEG frequencies between obsessive-compulsive disorder patients and Gilles de la Tourette patients
timeFrame: One year and a half
measure: percentage (%) of compulsions and tics detected by accelerometer
timeFrame: One year and a half
measure: Correlation of EEG frequency power (arbitrary units) detected before compulsions and scores get with clinical scales (Y-BOCS)
timeFrame: One year and a half
measure: Correlation between number of compulsions detected by accelerometer and Y-BOCS scores get by obsessive-compulsive patients
timeFrame: One year and a half
Other outcomes:
Locations:
city: Créteil
country: France
facility: Hôpital Albert Chenevier
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Luc MALLET, MD
role: PRINCIPAL_INVESTIGATOR
References: