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Objective Characterizatoion of Repetitive Behaviors

Primary Purpose

OCD, Tic Disorders, Gilles de la Tourette Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EEG
MRI
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for OCD focused on measuring Electrophysiology, Electroencephalogram, EEG, Accelerometer, Biomarker, Symptom provocation

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    GTS group

    OCD group

    Arm Description

    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).

    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).

    Outcomes

    Primary Outcome Measures

    modification of power (μV2) in EEG frequencies before compulsions in Obsessive-Compulsive Disorder patients
    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
    modification of power (μV2) in EEG frequencies before tics in Gilles de la Tourette patients
    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

    Difference in power (μV2) in EEG frequencies between obsessive-compulsive disorder patients and Gilles de la Tourette patients
    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
    percentage (%) of compulsions and tics detected by accelerometer
    percentage of compulsions and tics detected by accelerometer
    Correlation of EEG frequency power (arbitrary units) detected before compulsions and scores get with clinical scales (Y-BOCS)
    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
    Correlation between number of compulsions detected by accelerometer and Y-BOCS scores get by obsessive-compulsive patients
    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

    Full Information

    First Posted
    April 28, 2023
    Last Updated
    September 15, 2023
    Sponsor
    Institut National de la Santé Et de la Recherche Médicale, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06050369
    Brief Title
    Objective Characterizatoion of Repetitive Behaviors
    Official Title
    Actimetric and Electrophysiological Analyses of Repetitive Behaviors (Tics and Compulsions)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2024 (Anticipated)
    Study Completion Date
    October 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institut National de la Santé Et de la Recherche Médicale, France

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    OCD, Tic Disorders, Gilles de la Tourette Syndrome
    Keywords
    Electrophysiology, Electroencephalogram, EEG, Accelerometer, Biomarker, Symptom provocation

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    GTS group
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    OCD group
    Arm Type
    Experimental
    Arm Description
    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).
    Intervention Type
    Device
    Intervention Name(s)
    EEG
    Other Intervention Name(s)
    Electroencephalogram
    Intervention Description
    Recording, from the scalp, the electrophysiological activity of the brain.
    Intervention Type
    Device
    Intervention Name(s)
    MRI
    Other Intervention Name(s)
    magnetic resonance imaging
    Intervention Description
    Get the anatomical shape of the brain.
    Primary Outcome Measure Information:
    Title
    modification of power (μV2) in EEG frequencies before compulsions in Obsessive-Compulsive Disorder patients
    Description
    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
    Time Frame
    one year
    Title
    modification of power (μV2) in EEG frequencies before tics in Gilles de la Tourette patients
    Description
    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
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    Difference in power (μV2) in EEG frequencies between obsessive-compulsive disorder patients and Gilles de la Tourette patients
    Description
    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
    Time Frame
    One year and a half
    Title
    percentage (%) of compulsions and tics detected by accelerometer
    Description
    percentage of compulsions and tics detected by accelerometer
    Time Frame
    One year and a half
    Title
    Correlation of EEG frequency power (arbitrary units) detected before compulsions and scores get with clinical scales (Y-BOCS)
    Description
    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
    Time Frame
    One year and a half
    Title
    Correlation between number of compulsions detected by accelerometer and Y-BOCS scores get by obsessive-compulsive patients
    Description
    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
    Time Frame
    One year and a half

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Luc MALLET, MD
    Phone
    +33157274000
    Email
    luc.mallet@inserm.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hugues LAMOTHE, MD
    Phone
    +33149813195
    Email
    lamothehugues@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Luc MALLET, MD
    Organizational Affiliation
    Assistance Publique - Hôpitaux de Paris
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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