CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy) Clinical Trial
— PIDCOfficial title:
MRI of the Brachial Plexus and Chronic Inflammatory Demyelinating Polyradiculoneuropathy: Assessment of DTI-derived Measurements at 3.0-T
| Verified date | March 2018 |
| Source | University Hospital, Clermont-Ferrand |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | 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.
| Status | Completed |
| Enrollment | 45 |
| Est. completion date | December 31, 2015 |
| Est. primary completion date | December 31, 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Clermont-Ferrand | Clermont-Ferrand |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Clermont-Ferrand |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | At day 1 | |
| Secondary | 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. | At day 1 | |
| Secondary | 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. | at day 1 | |
| Secondary | 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 | at day 1 | |
| Secondary | Electrophysiological data analysis : motor conduction | Amplitude of compound muscle action potential (ACMAP), | at day 1 | |
| Secondary | Electrophysiological data analysis motor conduction | Motor conduction velocity (MCV) | at day 1 | |
| Secondary | Electrophysiological data analysis motor conduction | Motor distal latency (MDL) | at day 1 | |
| Secondary | Electrophysiological data analysis motor conduction | F-wave latency (FL) | at day 1 | |
| Secondary | Electrophysiological data analysis :motor conduction | terminal latency index (TLI)) | at day 1 | |
| Secondary | Electrophysiological data analysis : sensitive conduction | Amplitude of sensitive potential (ASP) | at day 1 | |
| Secondary | Electrophysiological data analysis : sensitive conduction | Sensitive conduction velocity (SCV) | at day 1 | |
| Secondary | Electrophysiological data analysis : sensitive conduction | Sensitive distal latency (SDL) | at day 1 |