- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06050369
Objective Characterizatoion of Repetitive Behaviors
Actimetric and Electrophysiological Analyses of Repetitive Behaviors (Tics and Compulsions)
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Luc MALLET, MD
- Phone Number: +33157274000
- Email: luc.mallet@inserm.fr
Study Contact Backup
- Name: Hugues LAMOTHE, MD
- Phone Number: +33149813195
- Email: lamothehugues@gmail.com
Study Locations
-
-
-
Créteil, France, 94010
- Recruiting
- Hôpital Henri Mondor
-
Contact:
- Luc Mallet
-
Créteil, France, 94000
- Recruiting
- Hôpital Albert Chenevier
-
Contact:
- Hugues Lamothe
-
Paris, France, 75013
- Recruiting
- Hopital Pitie Salpetriere
-
Contact:
- Andreas Hartmann
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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).
|
Recording, from the scalp, the electrophysiological activity of the brain.
Other Names:
Get the anatomical shape of the brain.
Other Names:
|
|
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).
|
Recording, from the scalp, the electrophysiological activity of the brain.
Other Names:
Get the anatomical shape of the brain.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
modification of power (μV2) in EEG frequencies before compulsions in Obsessive-Compulsive Disorder patients
Time Frame: 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
|
one year
|
|
modification of power (μV2) in EEG frequencies before tics in Gilles de la Tourette patients
Time Frame: 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
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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
|
One year and a half
|
|
percentage (%) of compulsions and tics detected by accelerometer
Time Frame: One year and a half
|
percentage of compulsions and tics detected by accelerometer
|
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 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
|
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
|
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
|
One year and a half
|
Collaborators and Investigators
Investigators
- Principal Investigator: Luc MALLET, MD, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Genetic Diseases, Inborn
- Neurodegenerative Diseases
- Neurodevelopmental Disorders
- Movement Disorders
- Heredodegenerative Disorders, Nervous System
- Basal Ganglia Diseases
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Tic Disorders
- Tourette Syndrome
- Diagnostic Techniques and Procedures
- Diagnosis
- Tomography
- Diagnostic Imaging
- Diagnostic Techniques, Neurological
- Electrodiagnosis
- Magnetic Resonance Imaging
- Electroencephalography
Other Study ID Numbers
- C21-48
- 2022-A01332-41 (Registry Identifier: ID RCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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