Serotonin Control of Impulsivity in Tourette Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Administration of a PET radiotracer.
- Who it may be relevant to
- Registry conditions: Tourette Disorder. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Involvement of the Serotonergic System in the Control of Impulsivity in Tourette Disorder.
Overview
Tourette disorder (TD) is a neurodevelopmental disorder characterized by motor and vocal tics. It is often associated with multiple psychiatric comorbidities involving a high degree of impulsivity such as obsessive-compulsive disorders (OCD), attention-deficit hyperactivity disorders (ADHD), and intermittent explosive disorders (IED). Although a substantial body of clinical studies have emphasized the role of the dopamine system in motor symptoms, little is known about how the serotonergic (5-HT) system modulate both cognitive and affective abilities in TD. Several lines of evidence suggest that different 5-HT receptor subtypes may constitute a crucial factor in the development and maintenance of different symptoms. Because abnormal 5-HT2A receptor bindings have been reported in patients with TD and aripiprazole (drug of first choice) is a 5-HT2A antagonist, we hypothesize that 5-HT2A receptors may play an important role in regulating psychiatric symptoms in TD such as those characterized by impulsive behaviors. To investigate the involvement of 5-HT2A receptors in TD, we propose to perform a multimodal imaging study with 20 adult patients (ON and OFF treatment). Neuroimaging data will be collected with a hybrid system that simultaneously combines the positron emission tomography (PET) and the functional magnetic resonance imaging (fMRI). A highly selective PET radiotracer (\[18F\]-altanserin) will map 5-HT2A receptor bindings in the whole brain, while fMRI will provide detail information regarding the altered brain activities.
Interventions
- Drug Administration of a PET radiotracer
A highly selective 5-HT2A receptor ligand (\[18F\]-altanserin) will be injected to patients before each PET scan. The IV injection in the arm (via a catheter) will be performed in continue during a period of 2 hours in the imaging centre (CERMEP) before the acquisition. The dose will be 2,6 MBq/kg +/- 10 % depending the prescription of the nuclear medicine. Patients will be evaluated twice, one time free of neuroleptic treatment and a second time during stable chronic treatment by neuroleptic.
Primary outcome measures
- Correlation coefficients between receptor-specific imaging data (PET) and scores of impulsivity measured by the Barratt scale (BIS11). [Time frame: As the analysis requires a complex imaging processing, this outcome measure will be assessed in the year following the acquisition.]
Secondary outcome measures (3)
- Correlation coefficients between receptor-specific imaging data (PET) and other clinical/behavioral scores. [Time frame: As the analysis requires a complex imaging processing, this outcome measure will be assessed in the year following the acquisition.]
- Correlation coefficients between functional imaging data (fMRI) and scores of impulsivity measured by the Barratt scale (BIS11). [Time frame: As the analysis requires a complex imaging processing, this outcome measure will be assessed in the year following the acquisition.]
- Correlation coefficients between functional imaging data (fMRI) and other clinical/behavioral scores. [Time frame: As the analysis requires a complex imaging processing, this outcome measure will be assessed in the year following the acquisition.]
Eligibility criteria
- Inclusion Criteria \* :
- Male or Female
- Diagnosed with a Tourette Disorder following the DSM-5
- Age between 18-65 years
- Member of a social security scheme in France
- Freely-given informed consent to participate to this study (written form)
- With a current treatment by aripiprazole already scheduled
- With Tics compatible with TEP/fMRI exams
- Having (for women only) effective contraception throughout participation in the study.
Exclusion Criteria \* :
- Male or Female
- A serious not controlled psychiatric comorbidity
- A serious, evolving or debilitating pathology with a potential influence on the study
- Drug-taking with serotonergic effects (e.g., amphetamine, cocaine, MDMA, SSRIs, mianserin)
- Contraindication for fMRI and PET (e.g., pacemaker, ferromagnetic implant, claustrophobia)
- Women breastfeeding
- Protected or restricted person (administratively or in judicial terms)
- Participants to another study with radiations or radiotracers since less of one year, participants to a concomitant study
- Do not speak french
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 2 centers
- Service de neurologie C Hôpital neurologique Pierre Wertheimer/GHE Hospices Civils de Lyon — Bron
- Centre de Référence Syndrome Gilles de la Tourette Département de Neurologie Pôle des Mala — Paris
Identifiers
NCT: NCT05942716 · 69HCL22_0683