NCT02877836

Brief Summary

The aim of this study is to evaluate the organization of the motor circuit in a group of patients suffering from dystonia compared with a group of healthy controls. Deep Brain stimulation is a functional neurosurgery technique consisting in neuromodulation of the motor circuit that has been applied to dystonia. The efficiency of this technique depends on the relative preservation of the function and the structure of the motor network . The assessment of neuronal circuit by advanced techniques of functional neuroimaging in this study might contribute to expand our understanding of the abnormalities in motor circuit activation and the integrity of CNS structure underlying dystonia. This study might contribute therefore to the refinement of Deep brain stimulation indications and techniques in complex dystonia syndromes

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
terminated

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

September 19, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 6, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
Last Updated

December 28, 2021

Status Verified

December 1, 2021

Enrollment Period

1.7 years

First QC Date

July 6, 2016

Last Update Submit

December 27, 2021

Conditions

Isolated Cervical DystoniaComplex DystoniaSpasticity

Keywords

DystoniafMRIDTIDBS

Outcome Measures

Primary Outcomes (2)

  • Integrity of Motor circuit reorganization in dystonia

    All the subjects participating in the study will undergo a Functional MRI study with a 'box and block' design comparing brain activity during the execution of a motor task and rest. Resting state fMRI will also be recorded. Statistical Parametric Mapping (SPM8) software will be used in order to perform spatially extended statistical processes to test the hypothesis whether there is a difference between both groups in functional imaging data. This analysis will provide a statistical map showing the clusters of brain activation where there is a significant difference between the group of dystonic patients and the group of healthy controls

    1 day

  • Integrity of corticospinal tract white matter in dystonia

    Fractional anisotropy (FA) is a measure derived of Diffusion tensor imaging that quantifies the degree of directionality of the local tract structure. This parameter is considered to be a marker for white matter tract integrity. FSL software will be used to analyse Diffusion Tensor Imaging (DTI) data 1. Tract-based spatial statistics (TBSS) will be used to obtain a voxelwise statistical map comparing fractional anisotropy in the major tracts in the group ot dystonic patients and the group of healthy controls. 2. Probabilistic tractography will be used to obtain tract-derived DTI parameters in the corticospinal and thalamocortical tracts that will be correlated with clinical scales (Burke-Fahn-Marsden Dystonia scale). Several DTI parameters will be analysed: mean fractional anisotropy, mean diffusivity, parallel and perpendicular diffusivity

    1 day

Secondary Outcomes (1)

  • Movement-related fMRI activation pattern in dystonic patients

    1 day

Study Arms (4)

Segmentary dystonia

OTHER

to identify movement-related functional magnetic resonance imaging (fMRI) activation patterns

Other: magnetic resonance imaging (fMRI)

Hemidystonia

OTHER

to identify movement-related functional magnetic resonance imaging (fMRI) activation patterns

Other: magnetic resonance imaging (fMRI)

Generalized dystonia

OTHER

to identify movement-related functional magnetic resonance imaging (fMRI) activation patterns

Other: magnetic resonance imaging (fMRI)

Healthy control subjects

OTHER

to identify movement-related functional magnetic resonance imaging (fMRI) activation patterns

Other: magnetic resonance imaging (fMRI)

Interventions

magnetic resonance imaging (fMRI)OTHER

To identify movement-related fMRI activation pattern in dystonic patients in comparison to healthy controls Assessment of white matter integrity in the corticospinal tract in a group og dystonic patients compared with the healthy control group

Generalized dystoniaHealthy control subjectsHemidystoniaSegmentary dystonia

Eligibility Criteria

Age18 Years - 84 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age limits ≥ 18 et \< 85 years
  • Right-handed patients/healthy controls, according to Edinburgh Handedness Inventory
  • The participating subjects must be affiliated to the French public health system
  • Written consent to participate in this study
  • For the patients
  • Patients affected by isolated or complex dystonia admitted to hospital in the Unit of Functional Neurosurgery in order to assess eligibility for deep cerebral stimulation therapy
  • Ability to understand the instructions to perform the experimental paradigm (the motor task) used in the design of the functional MRI
  • For the healthy control subjects :
  • Absence of current neurologic pathology
  • Absence of personal history of neurologic pathology, including perinatal anoxic injury, meningitis, vascular, metabolic, inflammatory pathology, epilepsy, cranial trauma with loss of consciousness or with associated neurological symptoms.
  • Absence of orthopaedic injury in the upper limbs

You may not qualify if:

  • Non Specific criteria
  • Contraindication for the realization of a MRI (pacemaker, valve prothesis non compatible with MRI, cochlear implant, aneuvrysmal clip, presence of an Intra-ocular metallic foreign object or coronary endoprosthesis)
  • Pregnancy, breastfeeding
  • Adults protected by the law
  • Non Specific criteria • Severe dyskinesia preventing the realization of motor task during functional MRI without general anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Montpellier

Montpellier, 34 295, France

Location

MeSH Terms

Conditions

Muscle SpasticityDystonia

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDyskinesias

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Victoria Gonzalez, MD PhD

    CHU de Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2016

First Posted

August 24, 2016

Study Start

September 19, 2014

Primary Completion

June 3, 2016

Study Completion

June 3, 2016

Last Updated

December 28, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)