OCDNCT06050369
Objective Characterizatoion of Repetitive Behaviors
A study testing EEG and MRI in people with OCD and Tic Disorders, run by Institut National de la Santé Et de la Recherche Médicale, France at 3 sites in France.
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). Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- OCD, Tic Disorders, Gilles de la Tourette Syndrome
- What is being tested?
- EEG and MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesFrance
- Study dates
- 28 Dec 2023to 27 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Hôpital Albert Chenevier
Créteil, 94000
Hugues Lamothe
- Recruiting
Hôpital Henri Mondor
Créteil, 94010
Luc Mallet
- Recruiting
Hôpital Pitié Salpêtrière
Paris, 75013
Andreas Hartmann
About this study
Official title: 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.
Read more
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).
- Conditions
- OCD, Tic Disorders, Gilles de la Tourette Syndrome
- Being tested
- EEG, MRI
- Keywords
- Electrophysiology, Electroencephalogram, EEG, Accelerometer, Biomarker, Symptom provocation
- Medical subject headings
- Tic Disorders, Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEGDevice
Also called Electroencephalogram
Recording, from the scalp, the electrophysiological activity of the brain.
MRIDevice
Also called magnetic resonance imaging
Get the anatomical shape of the brain.
| Study group | Role | What they receive |
|---|---|---|
| GTS group | Experimental | 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). Receives: Device: EEG; Device: MRI |
| OCD group | Experimental | 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). Receives: Device: EEG; Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
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
Measured: one year
Secondary outcomes (4)
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
Measured: One year and a half
percentage (%) of compulsions and tics detected by accelerometer
percentage of compulsions and tics detected by accelerometer
Measured: One year and a half
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
Measured: One year and a half
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
Measured: One year and a half
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start28 Dec 2023
- Primary completion27 Dec 2027 (estimated)
- Study completion27 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OCDStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Luc MALLET, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050369
- Sponsor's protocol ID
- C21-48
- Other IDs
- 2022-A01332-41
- Status last verified
- Feb 2026
- First submitted
- 28 Apr 2023
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No