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Trial record 22 of 65 for:    Recruiting, Not yet recruiting, Available Studies | "Dystonia"

Role of the Striatal Cholinergic System in the Pathophysiology of Dystonia (DYSCHOL)

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ClinicalTrials.gov Identifier: NCT02727361
Recruitment Status : Recruiting
First Posted : April 4, 2016
Last Update Posted : August 4, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
Dystonia is defined as a syndrome of sustained muscle contractions resulting in repetitive movements and abnormal postures. DYT1 is the most common form of genetic dystonia, but the link between genomic mutations and phenotypic expression remains largely unknown. Furthermore, secondary forms of dystonia have highlighted the role of the basal ganglia, particularly the putamen in the pathophysiology of the disease. Experimental results in a genetic model of dystonia in rodents suggest that cholinergic inter-neurons (ACh-I) of the putamen play a critical role in the pathological process of plasticity in the cortico-striatal synapse. However, these results have not been demonstrated in humans.

Condition or disease Intervention/treatment Phase
Dystonia Radiation: PET (Positron Emission Tomography) imaging Other: MRI : Magnetic Resonance Imaging Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Actual Study Start Date : January 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cholinergic striatal imaging
Cholinergic striatal imaging (IRM and TEP) to compare the intensity of the binding of cholinergic tracer
Radiation: PET (Positron Emission Tomography) imaging
Molecular imaging using a PET radiotracer of the vesicular acetylcholine transporter.

Other: MRI : Magnetic Resonance Imaging
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).




Primary Outcome Measures :
  1. Binding potential [ Time Frame: Inclusion (V0) ]
    Image (PET) of the intensity of fixation of Cholinergic tracer (Binding potential)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Man or woman 18 to 75 years, with health insurance
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02727361


Contacts
Contact: FERNANDEZ Philippe 0556765540 philippe.fernandez@chu-bordeaux.fr
Contact: FOUCHET Sandrine 0556795540 sandrine.fouchet@chu-bordeaux.fr

Locations
France
CHU de Bordeaux Recruiting
Bordeaux, France, 33076
Contact: FOUCHET Sandrine    0556795540    sandrine.fouchet@chu-bordeaux.fr   
Contact: BUISSON Caroline    0556795540    caroline.buisson@chu-bordeaux.fr   
Principal Investigator: FERNANDEZ Philippe         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: FERNANDEZ Philippe CHU Bordeaux
Study Chair: BURBAUD Pierre Université de Bordeaux

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02727361     History of Changes
Other Study ID Numbers: CHUBX2014/20
First Posted: April 4, 2016    Key Record Dates
Last Update Posted: August 4, 2017
Last Verified: August 2017

Keywords provided by University Hospital, Bordeaux:
Dystonia
Binding potential
FEOBV

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs