Impulsivity in Tourette Syndrome : Behavioral and Neuroimaging Study

Learn more about:
Related Clinical Trial
Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics Internet-based Cognitive Behavioral Therapy for Chronic Tic Disorder and Tourette’s Disorder: a Feasibility Trial Longitudinal Impact of Stressors in Adults With Tourette Syndrome Effects of Lactobacillus Plantarum PS128 in Patients With Tourette’s Syndrome Combined CBIT and rTMS to Improve Tourette’s Syndrome Pimavanserin Treatment in TS Median Nerve Stimulation (MNS) Pilot Extinction Learning in Adults With Tourette Syndrome Observational Database on Deep Brain Stimulation in Tourette Syndrome Influence of Stress and Psychiatric Symptoms on Children With Tourette Syndrome D-cycloserine Augmented Treatment for Youth With Tic Disorders Sensory Symptoms in Tourette Syndrome and Obsessive-Compulsive Disorder Atomoxetine in Patients With Tourette’s Syndrome Deep Brain Stimulation in Forel’s H Field in Tourette’s Syndrome Psychosocial Intervention for Young Children With Chronic Tics Brain Tissue Collection for Neuropathological Studies New Stereotactic Frame System for Neurosurgery Sedation During Microelectrode Recordings Before Deep Brain Stimulation for Movement Disorders. Outcomes Mandate National Integration With Cannabis as Medicine Reliability and Validity of the MINI International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) Brain-Behavior Interactions in Tic Suppression Phase III Study of 5LGr to Treat Tic Disorder Effects of Ondansetron in Obsessive-compulsive and Tic Disorders I-123 Brain Studies of Serotonin Metabolism in Psychiatric Patients and Normal Volunteers Physiological Investigations of Movement Disorders Dissemination of Comprehensive Behavioral Intervention for Tics (CBIT) to Occupational Therapists: A Feasibility Study TicHelper: A Computerized Comprehensive Behavioral Intervention for Tics (CBIT) Safety Study of Galantamine in Tic Disorders Internet-based Coaching for Young Adults With Neuropsychiatric Disorders Modified Comprehensive Behavioral Intervention for Tics (M_CBIT) Incorporating teleCBIT Into a Hospital-Based Tic Program Cognitive Behavior Therapy and Habit Reversal Training for the Treatment of Chronic Tic Disorders in Children An Exploratory Study of Transcranial Magnetic Stimulation (TMS) Based on Functional Magnetic Resonance Imaging (fMRI) in the Treatment of Tic Disorder Brain Stimulation in Movement Disorders Augmentation of Brief Habit Reversal Training With D-cycloserine or Placebo Central Mechanisms in Speech Motor Control Studied With H215O PET Comparison of Keppra and Clonidine in the Treatment of Tics Brain Activation in Vocal and Motor Tics Trial to Demonstrate the Efficacy and Safety of Internet-delivered Behavioral Treatment for Adults With Tic Disorders Assessment of Children With Tic Onset in the Past 6 Months Repetitive Transcranial Magnetic Stimulation to Reduce Tics Guanfacine in Children With Tic Disorders Neuropsychological Functioning Among Children With Tourret’s Disorder and ADHD Investigating Circadian Rhythms in Youth With Persistent Tic Disorders The Role of Probiotics PS128 in Movement Disorders Online Mindfulness-based Tic Reduction (Phase Two) Online Mindfulness-based Tic Reduction Investigation of Neurofeedback With Real-Time fMRI in Healthy Volunteers and Patients With Hyperkinetic Movement Disorders A Handwriting Intervention Program for Children With Tic Disorders Study of Clonidine on Sleep Architecture in Children With Tourette’s Syndrome (TS) and Comorbid ADHD National Gilles De La Tourette Study Group Evaluating the Efficacy and Safety of Yi-Gan San in Children and Adolescents With Tourette’s Disorder Evaluation of a Cognitive Psychophysiological Treatment for Tourette Syndrome and Tic Disorders Magnetic Resonance Spectroscopy to Evaluate Tourette s Syndrome Group Intervention for Children With Chronic Tics Syndrome or Tourette Syndrome: CBIT vs Psycho-Educational Intervention Study of the Neurobiology of Tourette Syndrome and Related Disorders Brain Dynamics Involved in Generating Tics and Controlling Voluntary Movement Dopaminergic Effects on Cortical Function in Tourette’s (Levodopa Protocol) Developmental Phenomenology of Obsessive Compulsive Disorder and Tourette Syndrome in Children and Adolescents Online Remote Behavioural Intervention for Tics (ORBIT) CANNAbinoids in the Treatment of TICS (CANNA-TICS) A Study to Test if TEV-50717 is Effective in Relieving Tics Associated With Tourette Syndrome Internet-delivered Behaviour Therapy for Children and Adolescents With Tourette’s Disorder A Study to Evaluate the Effects of ABX-1431 on Patients With Tourette Syndrome Aripiprazole in the Treatment of Tourette’s Syndrome Aripiprazole in Children and Adolescents With Chronic Tic Disorder or Tourette’s Disorder Phase II Double Blind Placebo Controlled Trial of Risperidone in Tourette Syndrome Phase III Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder Randomized Study of Pergolide in Children With Tourette Syndrome Phase II Pilot Controlled Study of Short Vs Longer Term Pimozide (Orap) Therapy in Tourette Syndrome tDCS in Tourette (TIC-TDCS) Anger Control Training for Youth With Tourette Syndrome Safety and Tolerability Study of NBI-98854 for the Treatment of Subjects With Tourette Syndrome Neurofeedback for Tourette Syndrome Brain Stimulation for the Treatment of Tourette Syndrome Study of Tics in Patients With Tourette’s Syndrome and Chronic Motor Tic Disorder Timing of Voluntary Movement in Patients With Tourette Syndrome and Chronic Tic Disorder Repetitive Transcranial Magnetic Stimulation of the Posterior Parietal Cortex in Patients Suffering From Gilles de la Tourette Syndrome Methylphenidate for Treating Children With ADHD and Tourette Syndrome Safety and Tolerability of Once-daily Oral Aripiprazole in Children and Adolescents With Tourette’s Disorder Tourette Syndrome and Seasonality (Stagionalità Tourette) Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette’s Disorder Role of the Sensory Experience in Generating Motor Tics in Tourette Syndrome Effectiveness of Behavior Therapy and Psychosocial Therapy for the Treatment of Tourette Syndrome and Chronic Tic Disorder Proof of Concept Study of an Oral Orthotic to Reduce Tic Severity in Chronic Tic Disorder and Tourette Syndrome Evaluation of Safety and Tolerability of Long-term TEV-50717 (Deutetrabenazine) for Treatment of Tourette Syndrome in Children and Adolescents Multi-site Transcranial Magnetic Stimulation Therapy of the Supplementary Motor Area in Children With Tourette Syndrome Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome A Randomized, Placebo-controlled, Tourette Syndrome Study. A Trial of Bilateral Deep Brain Stimulation to the Globus Pallidus Internum in Tourette Syndrome A Study of the Effectiveness and Safety of Tetrabenazine MR in Pediatric Subjects With Tourette’s Syndrome An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome. Thalamic Deep Brain Stimulation for Tourette Syndrome Exploration of Glutamatergic System With PET Radiotracer in Gilles de la Tourette Patients: Pilot Study (GlutaTour) ABF Tourette’s Disorder Post Marketing Surveillance Study Safety and Efficacy of NBI-98854 in Pediatric Subjects With Tourette Syndrome Brain Activity Associated With Tics in Patients With Tourette Syndrome Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome Internet-based Behaviour Therapy for Tourette’s Disorder and Chronic Tic Disorder Pramipexole Pilot Phase II Study in Children and Adolescents With Tourette Disorder According to DSM-IV Criteria Response Inhibition in Tourette Syndrome Alternatives for Reducing Tics in TS: A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents. Safety, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette Syndrome Pallidal Stimulation and Gilles de la Tourette Syndrome Developing New Treatments for Tourette Syndrome: Therapeutic Trials With Modulators of Glutamatergic Neurotransmission Evaluation of the HBDL Coil Transcranial Magnetic Stimulation (TMS) Device – Safety and Feasibility Study for the Treatment of Tourette Syndrome Pilot Study of the Modified Atkins Diet for Tourette Syndrome Trial to Evaluate the Long-term Efficacy of Oral Aripiprazole in the Treatment of Pediatric Subjects With Tourette’s Disorder Efficacy of a Therapeutic Combination of Dronabinol and PEA for Tourette Syndrome Pilot Study for Use of Dysport in Treatment of Vocal Tics in Patients With Tourette’s Syndrome A Study to Examine the Efficacy of a Therapeutic THX-110 for Tourette Syndrome Open Label Trial of Aripiprazole in Children and Adolescents With Tourette’s Disorder Open-label Extension Study of Pramipexole in the Treatment of Children and Adolescents With Tourette Syndrome Study Evaluating The Safety And Efficacy Of PF-03654746 In Adult Subjects With Tourette’s Syndrome Safety & Tolerability Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette’s Disorder Hypersensitivity in Tourette Syndrome Role of Frontal Cortex in the Pathophysiology of Gilles de la Tourette Syndrome (GTS) Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette’s Disorder Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette’s Disorder Safety and Efficacy Study of NBI-98854 in Adults With Tourette Syndrome VoIP Delivered Behavior Therapy for Tourette Syndrome Safety and Efficacy Study of NBI-98854 in Children and Adolescents With Tourette Syndrome Study of ABX-1431 in Adult Patients With Tourette Syndrome or Chronic Motor Tic Disorder Subthalamic Stimulation in Tourette’s Syndrome Study of GABA-A Receptors in the Generation of Tics in Patients With Tourette’s Syndrome Transcranial Magnetic Stimulation (TMS) for Individuals With Tourette’s Syndrome Neural Correlates of Sensory Phenomena in Tourette Syndrome Sensory Symptoms in Tourette Syndrome Tourette Syndrome Deep Brain Stimulation The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Tourette Syndrome Safety, Tolerability, Pharmacokinetic, and Efficacy Study of AZD5213 in Adolescents With Tourette’s Disorder Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Tourette’s Syndrome Facial Expression Recognition of Emotion and Categorization of Emotional Words in Gilles de la Tourette’s Syndrome Thalamic Deep Brain Stimulation for Tourette Syndrome Rollover Study for Continuing NBI-98854 Administration in Pediatric Subjects With Tourette Syndrome The Effect and Safety of Plum-blossom Needle for Tourette Syndrome Proof-of-Concept Safety Study of CPP-109 (Vigabatrin) for Treatment Refractory Tourette’s Disorder Ecopipam Treatment of Tourette Syndrome High Frequency Stimulation of the GPi or Thalamus in Tourette’s Syndrome Computerized Working Memory Training in Children With ADHD and Comorbid Tourette Syndrome Optimising Anterior Pallidal Deep Brain Stimulation for Tourette’s Syndrome MRI Study of Tic Remission in Tourette Syndrome Thalamic Deep Brain Stimulation for the Treatment of Refractory Tourette Syndrome Selective Microbiota Transplantation for Tourette’s Syndrome Parent Behavioral Training for Disruptive Behaviors in Tourette Syndrome A Pilot Study Of SD-809 (Deutetrabenazine) In Moderate To Severe Tourette Syndrome (TS) Impulsivity in Tourette Syndrome : Behavioral and Neuroimaging Study Developing Cognitive Training for Tourette Syndrome A Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of SNC-102 in Subjects With Tourette Syndrome Safety and Efficacy of Cannabis in Tourette Syndrome Activity in Tourette Syndrome FAAH Inhibitor Trial for Adults With Tourette Syndrome Open-Trial of EPI-743 for Adults With Tourette Syndrome Omega-3 Fatty Acids in Tourette’s Disorder Do Mirror Neurons Play a Role in Tourette Syndrome Physiopathology? A Pilot Study. Apathy in Tourette Syndrome and Changes in Quality of Life Sensory Processing in Tourette Syndrome The Pathophysiology of Tourette Syndrome: a Multimodal Study Behavioral Therapy for Tourette Syndrome Behavioral Therapy for Children and Adolescents With Tourette Syndrome Ecopipam Treatment of Tourette’s Syndrome in Subjects 7-17 Years Transcranial Magnetic Stimulation for Children With Tourette’s Syndrome

Brief Title

Impulsivity in Tourette Syndrome : Behavioral and Neuroimaging Study

Official Title

Identifying the Neural Correlates of Cognitive Impulsivity in Patients With Tourette Syndrome. "COGIT".

Brief Summary

      Tourette syndrome (TS) is characterized by the presence of multiple vocal and motor tics.
      Behavioral disorders associated with TS are common, particularly impulsivity, anti-sociality
      and socially inappropriate behavior. Specifically, cognitive impulsivity could be the source
      of these troubles. Its anatomical substrates is based on connections between frontal and
      striatal areas.

      Initially, a battery of behavioral tests measuring different types of impulsivity (motor,
      cognitive and decision) will be administered on three groups of subjects: TS: 80 patients (40
      patients treated and 40 untreated) and 40 healthy volunteers.

      Then, investigators will study the fronto-striatal connections in the TS group of 80 patients
      (40 patients treated and 40 untreated) compared to 40 healthy volunteers using neuroimaging
      techniques (3T MRI). The techniques used will be functional connectivity study of "resting
      state" MRI (RS-fMRI) combined with a reconstruction of white matter fibers by diffusion
      tensor imaging (DTI). Behavioral performance will be correlated with the correlation imaging
      data to highlight the functional anatomical substrates of impulsivity in patients with TS.

      Finally, investigators will look specifically using functional MRI activation, the anatomical
      and functional substrates of the three types of impulsivity (motor, cognitive and
      decision-making).

      Through this study, investigators hope to elucidate the anatomical and functional bases of
      cognitive impulsivity in patients with TS and thus lay the basis for more targeted
      treatments.
    



Study Type

Interventional


Primary Outcome

behavior performance (percentage of correct responses and reaction time)


Condition

Tourette Syndrome

Intervention

IRM and comportemental tasks

Study Arms / Comparison Groups

 TREATED PATIENT WITH TOURETTE SYNDROME
Description:  comportemental tasks included impulsivity tests will performed at V1 Resting state IRM will be performed at V2 40 patients

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

120

Start Date

October 2016

Completion Date

October 2020

Primary Completion Date

October 2018

Eligibility Criteria

        Inclusion Criteria:

        For all subjects:

          -  ≥ about 18 and 65 years old

          -  About receiving Social Security or universal health coverage or any equivalent plan

          -  About who signed the informed consent

        For TS patients treated :

          -  TS principal diagnosis, based on the DSM-5 criteria

          -  Stable pharmacological treatment at least 4 weeks prior to study entry;

          -  Possibility of controlling the majority tics of the upper part of the body lying down
             for at least 10 minutes (frequency tics on YGTSS <3).

        For TS patients untreated:

          -  TS principal diagnosis, based on the DSM-5 criteria

          -  No psychotropic treatments (neuroleptics, antidepressants or anxiolytics) mentioned at
             the time of inclusion.

          -  Possibility of controlling the majority tics of the upper part of the body lying down
             for at least 10 minutes (frequency tics on YGTSS <3).

        In healthy volunteers:

          -  Normal neurological examination (evaluation MINI).

          -  No regular pharmacological treatment with the exception of birth control pills for
             women

        Exclusion Criteria:

        For all patients TS:

          -  Age <18 years.

          -  Presence One of the following diagnoses Axis I DSM-5: schizophrenic disorders or
             current psychotic episode or in the past, bipolar disorder, current major depressive
             disorder autism spectrum.

          -  Abus Psychotropic substance dependency or a psychotropic substance, including alcohol
             (except nicotine).

          -  Support Regular / chronic drugs and other xenobiotics tropic psychotropic.

          -  Support Treatment with benzodiazepines in the 4 months prior to study entry. -Patient
             Subject to a measure of legal protection (guardianship, curatorship or safeguard
             justice). -No private freedom by administrative decision or justice.

          -  No Unable to consent and are not subject to a protection measure.

          -  Participation In other biomedical research or subjected to an exclusion period for
             another search.

          -  Problems General understanding.

          -  Weight Of more than 150 kg.

          -  Inability To maintain an upper portion of movement of the body lying down for at least
             10 minutes (frequency tics on YGTSS> 3).

        In healthy volunteers (HV):

          -  psychiatric disorders, cognitive impairment assessed by the MINI scale.

          -  About not being able to understand the tasks

          -  age <18 years.

          -  No Subject to a measure of legal protection (guardianship, curatorship or safeguard
             justice).

          -  Participation In other biomedical research or subjected to an exclusion period for
             another search.

          -  Not Unable to consent and are not subject to a protection measure.

          -  Not private freedom by administrative decision or court

        For TS patients (treated and untreated) and HV

          -  relative to MRI 3Tesla : pacemaker, cardiac cell or neural stimulator ferromagnetic
             surgical clips body intraocular or intracranial metallic foreign cochlear implant
             artificial heart valve or arterial metal surgical equipment metallic material that
             could concentrate the radio frequency pulses pregnant women, women in labor or
             lactating aneurism Standing up the eyelids vascular malformation of the brain

          -  Topic not wishing to be informed of a clinically significant abnormality discovered
             during the realization of MRI
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, 01 42 16 13 16, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02960698

Organization ID

C16-07

Secondary IDs

2016-A00936-45

Responsible Party

Sponsor

Study Sponsor

Institut National de la Santé Et de la Recherche Médicale, France


Study Sponsor

, , 


Verification Date

October 2016