NCT02727361

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 4, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

2.2 years

First QC Date

March 21, 2016

Last Update Submit

February 22, 2019

Conditions

Dystonia

Keywords

DystoniaBinding potentialFEOBV

Outcome Measures

Primary Outcomes (1)

  • Binding potential

    Image (PET) of the intensity of fixation of Cholinergic tracer (Binding potential)

    Inclusion (V0)

Study Arms (1)

Cholinergic striatal imaging

EXPERIMENTAL

Cholinergic striatal imaging (IRM and TEP) to compare the intensity of the binding of cholinergic tracer

Radiation: PET (Positron Emission Tomography) imagingOther: MRI : Magnetic Resonance Imaging

Interventions

PET (Positron Emission Tomography) imagingRADIATION

Molecular imaging using a PET radiotracer of the vesicular acetylcholine transporter.

Cholinergic striatal imaging
MRI : Magnetic Resonance ImagingOTHER

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).

Cholinergic striatal imaging

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Dystonia

Interventions

2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazoleMagnetic Resonance SpectroscopyX-Rays

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • FERNANDEZ Philippe

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • BURBAUD Pierre

    University of Bordeaux

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2016

First Posted

April 4, 2016

Study Start

January 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

February 25, 2019

Record last verified: 2019-02

Locations

FR(1)