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NCT Number: NCT03460951

Diffusion Tensor Imaging in Chronic Inflammatory Demyelinating Polyneuropathy (PIDC)

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.

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Key information

Conditions

CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy) Autoimmune Diseases Autoimmune Diseases of the Nervous System CMT (Charcot Marie Tooth Disease) Charcot-Marie-Tooth Disease Chronic Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Demyelinating Diseases Disease Attributes Genetic Diseases, Inborn Hereditary Sensory and Motor Neuropathy Heredodegenerative Disorders, Nervous System Immune System Diseases Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Polyradiculoneuropathy Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cervical MRI

Diagnostic Test

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)

Primary outcomes

  1. Mean Fractional Anisotropy in C5 to C8 nerve roots in CIDP patients compared to CMT-1A patients and healthy controls.

    Time frame: At day 1

    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.

Secondary outcomes

  1. Apparent Diffusion Coefficient (ADC) values in C5 to C8 nerve roots in CIDP patients compared to CMT-1A patients and healthy controls

    Time frame: At day 1

    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.

  2. Cervical nerve roots diameter

    Time frame: at day 1

    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.

  3. Clinical data analysis

    Time frame: at day 1

    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

  4. Electrophysiological data analysis : motor conduction

    Time frame: at day 1

    Amplitude of compound muscle action potential (ACMAP),

  5. Electrophysiological data analysis motor conduction

    Time frame: at day 1

    Motor conduction velocity (MCV)

  6. Electrophysiological data analysis motor conduction

    Time frame: at day 1

    Motor distal latency (MDL)

  7. Electrophysiological data analysis motor conduction

    Time frame: at day 1

    F-wave latency (FL)

  8. Electrophysiological data analysis :motor conduction

    Time frame: at day 1

    terminal latency index (TLI))

  9. Electrophysiological data analysis : sensitive conduction

    Time frame: at day 1

    Amplitude of sensitive potential (ASP)

  10. Electrophysiological data analysis : sensitive conduction

    Time frame: at day 1

    Sensitive conduction velocity (SCV)

  11. Electrophysiological data analysis : sensitive conduction

    Time frame: at day 1

    Sensitive distal latency (SDL)

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

MRI of the Brachial Plexus and Chronic Inflammatory Demyelinating Polyradiculoneuropathy: Assessment of DTI-derived Measurements at 3.0-T

Acronym: PIDC

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 9, 2018
Registry last updated
Mar 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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