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Diffusion Tensor Imaging in Chronic Inflammatory Demyelinating Polyneuropathy (PIDC) (PIDC)

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ClinicalTrials.gov Identifier: NCT03460951
Recruitment Status : Completed
First Posted : March 9, 2018
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.


Condition or disease Intervention/treatment
CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy) CMT (Charcot Marie Tooth Disease) Diagnostic Test: cervical MRI

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.

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Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: MRI of the Brachial Plexus and Chronic Inflammatory Demyelinating Polyradiculoneuropathy: Assessment of DTI-derived Measurements at 3.0-T
Actual Study Start Date : November 18, 2013
Actual Primary Completion Date : December 31, 2015
Actual Study Completion Date : December 31, 2015


Group/Cohort Intervention/treatment
CIDP patients
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
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)

Normal volunteers
15 healthy subjects matched for age and gender to CIDP patients
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)

Charcot-Marie-Tooth disease type 1A patients (CMT-1A)
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)




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
men or women
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03460951


Locations
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France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Frédéric TAITHE University Hospital, Clermont-Ferrand

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03460951     History of Changes
Other Study ID Numbers: CHU-379
2013-A00808-37 ( Other Identifier: 2013-A00808-37 )
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Clermont-Ferrand:
Feasibility and reproductibility
DTI parameters (Fractional Anisotropy, Apparent Diffusion Coefficient)
MRI morphological parameters (T1, STIR)

Additional relevant MeSH terms:
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Charcot-Marie-Tooth Disease
Nerve Compression Syndromes
Hereditary Sensory and Motor Neuropathy
Tooth Diseases
Polyradiculoneuropathy
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Stomatognathic Diseases
Nervous System Malformations
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Congenital Abnormalities
Genetic Diseases, Inborn
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases