Objective Characterizatoion of Repetitive Behaviors

OCD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06050369
• Other study ID #: C21-48
• Secondary ID: 2022-A01332-41
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: October 1, 2026

Study information

• Verified date: April 2023
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Luc MALLET, MD
• Phone: +33157274000
• Email: luc.mallet[@]inserm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gilles de la Tourette Syndrome
• OCD
• Tic Disorders
• Tourette Syndrome

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Albert Chenevier	Créteil
France	Hôpital Henri Mondor	Créteil
France	Hôpital Pitié Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	one year
Primary	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	one year
Secondary	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	One year and a half
Secondary	percentage (%) of compulsions and tics detected by accelerometer	percentage of compulsions and tics detected by accelerometer	One year and a half
Secondary	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	One year and a half
Secondary	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	One year and a half