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Functional MRI and DTI in the Preoperative Assessment of Dystonia (IRMF-DIFF)

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Terminated

Conditions

Spasticity
Complex Dystonia
Isolated Cervical Dystonia

Treatments

Other: magnetic resonance imaging (fMRI)

Study type

Interventional

Funder types

Other

Identifiers

NCT02877836
9095 (Other Identifier)

Details and patient eligibility

About

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

Full description

Advances in the field of functional neurosurgery, neuroradiology and virus neuronal tracing studies have expanded our knowledge of the circuits underlying the clinical expression of several neurologic syndromes. Globus pallidus internus (GPi) Deep brain stimulation (DBS) is a validated technique for the treatment of 'isolated dystonia'. The efficiency of this therapy in 'complex dystonia', commonly associated with focal brain lesions, is limited and heterogeneous. Broadening indications for DBS therapy to complex DDS disorders require further improvement of preoperative assessment of motor circuit functional reorganization and white matter integrity. The efficacy of neuromodulation in these clinical syndromes is determined by the severity of pyramidal involvement, the interactions between cortico-striato-pallido-thalamic and cerebello-thalamo-cortical circuits and motor network reorganization at the cortical level.

The aim of the study is to identify movement-related functional magnetic resonance imaging (fMRI) activation patterns in a group of dystonic patients in comparison to healthy controls (HC). Further analysis will assess the recruitment pattern in different patient subgroups defined according to clinical and radiological criteria relevant to GPi DBS eligibility (hyperkinetic/ hypokinetic and prepallidal/ postpallidal). Diffusion tensor imaging (DTI) will be applied to the assessment of the topographic distribution and severity of white matter lesions in the group of dystonic patients in comparison with HC.

Further knowledge concerning motor network organization and white matter integrity after focal brain lesions might contribute to the understanding of this mitigated response to DBS and to the refinement of DBS indications and techniques in secondary dystonia

Enrollment

36 patients

Sex

All

Ages

18 to 84 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

36 participants in 4 patient groups

Segmentary dystonia
Other group
Description:
to identify movement-related functional magnetic resonance imaging (fMRI) activation patterns
Treatment:
Other: magnetic resonance imaging (fMRI)
Hemidystonia
Other group
Description:
to identify movement-related functional magnetic resonance imaging (fMRI) activation patterns
Treatment:
Other: magnetic resonance imaging (fMRI)
Generalized dystonia
Other group
Description:
to identify movement-related functional magnetic resonance imaging (fMRI) activation patterns
Treatment:
Other: magnetic resonance imaging (fMRI)
Healthy control subjects
Other group
Description:
to identify movement-related functional magnetic resonance imaging (fMRI) activation patterns
Treatment:
Other: magnetic resonance imaging (fMRI)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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