Clinical trial NCT03460951: Diffusion Tensor Imaging in Chronic Inflammatory Demyelinating Polyneuropathy (PIDC)
Official title: MRI of the Brachial Plexus and Chronic Inflammatory Demyelinating Polyradiculoneuropathy: Assessment of DTI-derived Measurements at 3.0-T
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)
CMT (Charcot Marie Tooth Disease)
Keywords: Feasibility and reproductibility
DTI parameters (Fractional Anisotropy, Apparent Diffusion Coefficient)
MRI morphological parameters (T1, STIR)
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: men or women

Brief summary: The main purpose of this study is to assess the clinical feasibility of diffusion tensor imaging (DTI) for the diagnosis of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). For thar purpose, investigator will compare, fractional anisotropy (FA) obtained by diffusion tensor imaging (DTI) MRI 3T on brachial plexus and cervical spinal nerve roots between patients with defined Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), according to the EFNS 2010 criteria, and healthy controls.

The secondary outcomes will be to compare DTI parameters (FA, ADC or Apparent Diffusion Coefficient) between CIDP patients, healthy volunteers, and patients with Charcot Marie Tooth disease type 1a (CMT1a) and MRI morphological parameters (T1, STIR) between these groups. Moreover, investigator will investigate the possible relationship between MRI parameters, clinical indices, and electrophysiological measure.

Detailed description: Investigator will prospectively enroll 15 patients with CIDP followed in the Neurology Department of Clermont Ferrand University Hospital, who satisfy the Joint Task Force of the EFNS and PNS definite CIDP criteria. Two control groups will be studied in parallel, including 15 healthy volunteers on one side, and 15 patients with CMT-1A on the other side (proven by genetic testing). Using a 3-T magnetic resonance imaging scanner, we will obtain DTI scans of brachial plexus of these 3 groups, prepare fractional anisotropy (FA) maps, and compare these values between groups. Investigator will evaluate MRI imaging findings too (coronal STIR, T1-weighted images,and DWIs). MRI studies will be reviewed independently by two neuroradiologists, blinded to clinical informations. In all patients with CIDP, investigator will also performs clinical evaluation and electroneuromyography. Correlation between FA values clinical indices will be examined.

Eligibility criteria: Inclusion Criteria:

* - For All patients: at least 18 years-old.
* For CMT1a group : CMT1 a should be proven by genetic testing
* For CIDP group: CIDP should satisfied the definite CIDP criteria of the Joint Task Force of the EFNS and PNS 1 (situations A and B according to the French CIDP work group2). They might have received steroids, immunoglobulin or immunosuppressive treatments

Exclusion Criteria:

* For all groups: any neurological comorbidity, other causes of neuropathy or history of exposure to neurotoxic agents (the inclusion and exclusion criteria are detailed in supplemental data) allergies, renal failure, Pregnancy

Primary outcomes:
measure: Mean Fractional Anisotropy in C5 to C8 nerve roots in CIDP patients compared to CMT-1A patients and healthy controls.
timeFrame: At day 1
Secondary outcomes:
measure: Apparent Diffusion Coefficient (ADC) values in C5 to C8 nerve roots in CIDP patients compared to CMT-1A patients and healthy controls
timeFrame: At day 1
measure: Cervical nerve roots diameter
timeFrame: at day 1
measure: Clinical data analysis
timeFrame: at day 1
measure: Electrophysiological data analysis : motor conduction
timeFrame: at day 1
measure: Electrophysiological data analysis motor conduction
timeFrame: at day 1
measure: Electrophysiological data analysis motor conduction
timeFrame: at day 1
measure: Electrophysiological data analysis motor conduction
timeFrame: at day 1
measure: Electrophysiological data analysis :motor conduction
timeFrame: at day 1
measure: Electrophysiological data analysis : sensitive conduction
timeFrame: at day 1
measure: Electrophysiological data analysis : sensitive conduction
timeFrame: at day 1
measure: Electrophysiological data analysis : sensitive conduction
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Frédéric TAITHE
role: PRINCIPAL_INVESTIGATOR
References: