An observational study in CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy) and CMT (Charcot Marie Tooth Disease), sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-09.
Sponsored by University Hospital, Clermont-Ferrand · Observational
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.
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.
men or women
Exclusion Criteria:
15 patients with CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy ) who satisfy 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), and who agree to undergo cervical MRI.
Diagnostic Test: cervical MRI
15 healthy subjects matched for age and gender to CIDP patients
Diagnostic Test: cervical MRI
15 CMT-1A patients (proven by genetic testing), will be included as Charcot-Marie-Tooth disease type 1A patients (CMT-1A) is one of the main differential diagnoses of CIDP characterized by the diffuse demyelination of peripheral nerves.
Diagnostic Test: cervical MRI
Cervical MRI will be performed in all of the patients and controls on a 3.0-T scanner (Discovery MR750, General Electric (GE) Medical Systems, Milwaukee, WI, USA)
Mean Fractional Anisotropy in C5 to C8 nerve roots in CIDP patients compared to CMT-1A patients and healthy controls.
Diffusion Tensor Imaging (DTI) is a modality of Diffusion-Weighted Imaging (DWI). Fractional Anisotropy (FA) and Apparent Diffusion Coefficient (ADC) values, determines the magnitude of directionality of diffusion.
Time frame: At day 1
Apparent Diffusion Coefficient (ADC) values in C5 to C8 nerve roots in CIDP patients compared to CMT-1A patients and healthy controls
Diffusion Tensor Imaging (DTI) is a modality of Diffusion-Weighted Imaging (DWI). Fractional Anisotropy (FA) and Apparent Diffusion Coefficient (ADC) values, determines the magnitude of directionality of diffusion.
Time frame: At day 1
Cervical nerve roots diameter
The diameters of cervical nerve roots (C6-C8) will be measured at the outlet of the intervertebral canal, on coronal STIR sequences, using an ADW 4.5 workstation.
Time frame: at day 1
Clinical data analysis
Disease severity at inclusion (Medical Research Council score (MRC), INCAT sensory sum score (INCAT), Overall Neuropathy Limitation Scale (ONLS)) will be prospectively assessed by the same study investigator. We will also perform nerve conduction studies on all the CIDP patients
Time frame: at day 1
Electrophysiological data analysis : motor conduction
Amplitude of compound muscle action potential (ACMAP),
Time frame: at day 1
Electrophysiological data analysis motor conduction
Motor conduction velocity (MCV)
Time frame: at day 1
Electrophysiological data analysis motor conduction
Motor distal latency (MDL)
Time frame: at day 1
Electrophysiological data analysis motor conduction
F-wave latency (FL)
Time frame: at day 1
Electrophysiological data analysis :motor conduction
terminal latency index (TLI))
Time frame: at day 1
Electrophysiological data analysis : sensitive conduction
Amplitude of sensitive potential (ASP)
Time frame: at day 1
Electrophysiological data analysis : sensitive conduction
Sensitive conduction velocity (SCV)
Time frame: at day 1
Electrophysiological data analysis : sensitive conduction
Sensitive distal latency (SDL)
Time frame: at day 1
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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University Hospital, Clermont-Ferrand