Clinical trial NCT02877836: Functional MRI and DTI in the Preoperative Assessment of Dystonia
Official title: Functional Magnetic Resonance and Diffusion Tensor Imaging in the Preoperative Assessment of Dystonia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Isolated Cervical Dystonia
Complex Dystonia
Spasticity
Keywords: Dystonia
fMRI
DTI
DBS
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Integrity of Motor circuit reorganization in dystonia
timeFrame: 1 day
measure: Integrity of corticospinal tract white matter in dystonia
timeFrame: 1 day
Secondary outcomes:
measure: Movement-related fMRI activation pattern in dystonic patients
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier
Study officials:
affiliation: CHU de Montpellier
name: Victoria Gonzalez, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: