Objective Characterizatoion of Repetitive Behaviors

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06050369
Collaborator
(none)
50
2
36

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: EEG
  • Device: MRI
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Actimetric and Electrophysiological Analyses of Repetitive Behaviors (Tics and Compulsions)
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: GTS group

This arm will be studied to get some electrophysiological marker of tics. The patients will be their own control (periods with symptoms vs. free symptoms periods).

Device: EEG
Recording, from the scalp, the electrophysiological activity of the brain.
Other Names:
  • Electroencephalogram
  • Device: MRI
    Get the anatomical shape of the brain.
    Other Names:
  • magnetic resonance imaging
  • Experimental: OCD group

    This arm will be studied to get some electrophysiological marker of compulsions. The patients will be their own control (periods with symptoms vs. free symptoms periods).

    Device: EEG
    Recording, from the scalp, the electrophysiological activity of the brain.
    Other Names:
  • Electroencephalogram
  • Device: MRI
    Get the anatomical shape of the brain.
    Other Names:
  • magnetic resonance imaging
  • Outcome Measures

    Primary Outcome Measures

    1. modification of power (μV2) in EEG frequencies before compulsions in Obsessive-Compulsive Disorder patients [one year]

      change in the power EEG frequencies in OCD patients before compulsions EEG frequencies come to 0 to 250 Hz, the power is the amplitude of oscillations

    2. modification of power (μV2) in EEG frequencies before tics in Gilles de la Tourette patients [one year]

      change in the power of EEG frequencies in GTS patients before tics EEG frequencies come to 0 to 250 Hz, the power is the amplitude of oscillations

    Secondary Outcome Measures

    1. Difference in power (μV2) in EEG frequencies between obsessive-compulsive disorder patients and Gilles de la Tourette patients [One year and a half]

      Difference in the power in the EEG frequencies between obsessive-compulsive disorder patients and Gilles de la Tourette patients EEG frequencies come to 0 to 250 Hz, the power is the amplitude of oscillations

    2. percentage (%) of compulsions and tics detected by accelerometer [One year and a half]

      percentage of compulsions and tics detected by accelerometer

    3. Correlation of EEG frequency power (arbitrary units) detected before compulsions and scores get with clinical scales (Y-BOCS) [One year and a half]

      Correlation between power in EEG frequencies and Y-BOCS score get by each individual patients Y-BOCS = Yale-Brown Obsessive-Compulsive Scale; Scores range from 0 to 40 with 40 corresponding to the maximum severity of symptoms

    4. Correlation between number of compulsions detected by accelerometer and Y-BOCS scores get by obsessive-compulsive patients [One year and a half]

      Correlation between number of compulsions detected by accelerometer and Y-BOCS scores get by obsessive-compulsive patients Y-BOCS = Yale-Brown Obsessive-Compulsive Scale; Scores range from 0 to 40 with 40 corresponding to the maximum severity of symptoms

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Institut National de la Santé Et de la Recherche Médicale, France

    Investigators

    • Principal Investigator: Luc MALLET, MD, Assistance Publique - Hôpitaux de Paris

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Institut National de la Santé Et de la Recherche Médicale, France
    ClinicalTrials.gov Identifier:
    NCT06050369
    Other Study ID Numbers:
    • C21-48
    • 2022-A01332-41
    First Posted:
    Sep 22, 2023
    Last Update Posted:
    Sep 22, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 22, 2023