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

Primary Purpose

Dystonia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PET (Positron Emission Tomography) imaging
MRI : Magnetic Resonance Imaging
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dystonia focused on measuring Dystonia, Binding potential, FEOBV

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU de Bordeaux

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cholinergic striatal imaging

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 21, 2016
Last Updated
February 22, 2019
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT02727361
Brief Title
Role of the Striatal Cholinergic System in the Pathophysiology of Dystonia
Acronym
DYSCHOL
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
March 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dystonia
Keywords
Dystonia, Binding potential, FEOBV

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cholinergic striatal imaging
Arm Type
Experimental
Arm Description
Cholinergic striatal imaging (IRM and TEP) to compare the intensity of the binding of cholinergic tracer
Intervention Type
Radiation
Intervention Name(s)
PET (Positron Emission Tomography) imaging
Intervention Description
Molecular imaging using a PET radiotracer of the vesicular acetylcholine transporter.
Intervention Type
Other
Intervention Name(s)
MRI : Magnetic Resonance Imaging
Intervention Description
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 Measure Information:
Title
Binding potential
Description
Image (PET) of the intensity of fixation of Cholinergic tracer (Binding potential)
Time Frame
Inclusion (V0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FERNANDEZ Philippe
Organizational Affiliation
CHU Bordeaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
BURBAUD Pierre
Organizational Affiliation
University of Bordeaux
Official's Role
Study Chair
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France

12. IPD Sharing Statement

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Role of the Striatal Cholinergic System in the Pathophysiology of Dystonia

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