Objective Characterizatoion of Repetitive Behaviors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-65
SponsorInstitut National de la Santé Et de la Recherche Médicale, France
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
EEG
DeviceRecording, from the scalp, the electrophysiological activity of the brain.
MRI
DeviceGet the anatomical shape of the brain.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: GTS groupExperimental treatment 2 interventions
Group B: OCD groupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
one year2
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
Time frame
one yearSecondary outcomes
1
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
Time frame
One year and a half2
percentage (%) of compulsions and tics detected by accelerometer
percentage of compulsions and tics detected by accelerometer
Time frame
One year and a half3
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
Time frame
One year and a half4
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
Time frame
One year and a halfSponsors and contacts
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Source ClinicalTrials.gov