NCT06050369

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Dec 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Dec 2023Dec 2027

First Submitted

Initial submission to the registry

April 28, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

December 28, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2027

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

4 years

First QC Date

April 28, 2023

Last Update Submit

February 10, 2026

Conditions

Keywords

ElectrophysiologyElectroencephalogramEEGAccelerometerBiomarkerSymptom provocation

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Difference in power (μV2) in EEG frequencies between obsessive-compulsive disorder patients and Gilles de la Tourette patients

    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)

    One year and a half

  • Correlation between number of compulsions detected by accelerometer and Y-BOCS scores get by obsessive-compulsive patients

    One year and a half

Study Arms (2)

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).

Device: EEGDevice: 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).

Device: EEGDevice: MRI

Interventions

EEGDEVICE

Recording, from the scalp, the electrophysiological activity of the brain.

Also known as: Electroencephalogram
GTS groupOCD group
MRIDEVICE

Get the anatomical shape of the brain.

Also known as: magnetic resonance imaging
GTS groupOCD group

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hôpital Albert Chenevier

Créteil, 94000, France

RECRUITING

Hôpital Henri Mondor

Créteil, 94010, France

RECRUITING

Hôpital Pitié Salpêtrière

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Tic DisordersTourette Syndrome

Interventions

ElectroencephalographyMagnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurodevelopmental DisordersMental DisordersBasal Ganglia DiseasesBrain DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisTomographyDiagnostic Imaging

Study Officials

  • Luc MALLET, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hugues LAMOTHE, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2023

First Posted

September 22, 2023

Study Start

December 28, 2023

Primary Completion (Estimated)

December 27, 2027

Study Completion (Estimated)

December 27, 2027

Last Updated

February 12, 2026

Record last verified: 2026-02

Locations