- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02727361
Role of the Striatal Cholinergic System in the Pathophysiology of Dystonia (DYSCHOL)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to demonstrate that the phenotype of dystonia is associated with the degree of striatal ACh-I alterations.
In this molecular imaging study, the investigators will directly test this hypothesis using a PET radiotracer of the vesicular acetylcholine transporter (VAT). Their goal is to explore the relationships between cholinergic dysfunction and clinical disease expression and the associated morphological and functional alterations. The experimental protocol will also include multimodal MRI, MRI diffusion tensor (to study the microscopic structure of white matter) and functional MRI of the resting state (to study the functional organization of cerebral cholinergic networks at rest).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bordeaux, France, 33076
- CHU de Bordeaux
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Man or woman 18 to 75 years, with health insurance European health insurance card (for resident patients in EU), insurance by bilateral social security agreement signed between his country and France (for resident patients outside the EU)
- Diagnosis of dystonia DYT1 confirmed by molecular biology (TORSINE- A gene mutation)
- Patient who stopped his anticholinergic treatment 48 hours before imaging
Exclusion Criteria:
- Patients who underwent surgery for deep brain stimulation or under cholinergic treatment.
- Presence of a counter-indication for MRI
- Presence of a counter-indication for TEP Scan with [18F]-FEOBV
- Woman premenopausal without effective ongoing contraception (intrauterine device or combined hormonal)
- Patient who underwent a PET examination in the previous month
- Presence of any health problem preventing travel to the imaging service of the University Hospital
- Being under the legal guardianship of another person or being unable to provide consent to participate
- Pregnant or breastfeeding woman
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cholinergic striatal imaging
Cholinergic striatal imaging (IRM and TEP) to compare the intensity of the binding of cholinergic tracer
|
Molecular imaging using a PET radiotracer of the vesicular acetylcholine transporter.
Multimodal MRI, MRI diffusion tensor (to study the microscopic structure of white matter) and functional MRI of the resting state (to study the functional organization of cerebral cholinergic networks at rest).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Binding potential
Time Frame: Inclusion (V0)
|
Image (PET) of the intensity of fixation of Cholinergic tracer (Binding potential)
|
Inclusion (V0)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: FERNANDEZ Philippe, Chu Bordeaux
- Study Chair: BURBAUD Pierre, University of Bordeaux
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX2014/20
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dystonia
-
University of Texas Southwestern Medical CenterMassachusetts General HospitalRecruitingDystonia | Dystonia; Idiopathic | Dystonia, Primary | Dystonia, Secondary | Dystonia, Familial | Dystonia Disorder | Dystonias, Sporadic | Dystonia; Orofacial | Dystonia Lenticularis | Dystonia, Paroxysmal | Dystonia 6 | Dystonia 5 | Dystonia 8 | Dystonia 9 | Dystonia 19 | Dystonia 10 | Dystonia 11 | Dystonia 20 | Dystonia 12 | Dystonia... and other conditionsUnited States
-
Fondation Ophtalmologique Adolphe de RothschildCompletedCervical Dystonia, PrimaryFrance
-
University Hospital, MontpellierTerminatedSpasticity | Isolated Cervical Dystonia | Complex DystoniaFrance
-
National Institute of Neurological Disorders and...Active, not recruitingDystonia | Focal Dystonia | Musician's DystoniaUnited States
-
University of FloridaBachmann Strauss Dystonia & Parkinson Foundation, Inc.Completed
-
University Hospital, MontpellierTerminatedTardive Dystonia | Generalized Dystonia | Segmental DystoniaFrance
-
Duke UniversityAmerican Academy of NeurologyNot yet recruiting
-
Institut National de la Santé Et de la Recherche...Assistance Publique - Hôpitaux de ParisNot yet recruiting
-
University of Colorado, DenverCompleted
-
National Institute of Neurological Disorders and...Completed
Clinical Trials on PET (Positron Emission Tomography) imaging
-
Jagiellonian UniversityMedical University of WarsawCompletedNeurodegenerative Diseases | Brain Neoplasms | Neuroendocrine TumorsPoland
-
NYU Langone HealthYale UniversityTerminatedPost-traumatic Stress Disorder (PTSD)United States
-
Massachusetts General HospitalNational Heart, Lung, and Blood Institute (NHLBI)Recruiting
-
University of WashingtonNational Cancer Institute (NCI)CompletedAdult Solid NeoplasmUnited States
-
Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)WithdrawnOropharyngeal Squamous Cell Carcinoma | HPV Positive Oropharyngeal Squamous Cell Carcinoma
-
Chinese PLA General HospitalUnknown
-
Stanford UniversityNational Cancer Institute (NCI)CompletedPancreatic Carcinoma | Healthy SubjectUnited States
-
Stanford UniversityRecruiting
-
University of Texas Southwestern Medical CenterWithdrawn
-
The Hospital for Sick ChildrenCompleted