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Trial record 3 of 25 for:    nerve | CIDP

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

Tracking Information
First Submitted Date February 16, 2018
First Posted Date March 9, 2018
Last Update Posted Date March 9, 2018
Actual Study Start Date November 18, 2013
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 8, 2018)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 8, 2018)
  • 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.
  • 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.
  • 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
  • Electrophysiological data analysis : motor conduction [ Time Frame: at day 1 ]
    Amplitude of compound muscle action potential (ACMAP),
  • Electrophysiological data analysis motor conduction [ Time Frame: at day 1 ]
    Motor conduction velocity (MCV)
  • Electrophysiological data analysis motor conduction [ Time Frame: at day 1 ]
    Motor distal latency (MDL)
  • Electrophysiological data analysis motor conduction [ Time Frame: at day 1 ]
    F-wave latency (FL)
  • Electrophysiological data analysis :motor conduction [ Time Frame: at day 1 ]
    terminal latency index (TLI))
  • Electrophysiological data analysis : sensitive conduction [ Time Frame: at day 1 ]
    Amplitude of sensitive potential (ASP)
  • Electrophysiological data analysis : sensitive conduction [ Time Frame: at day 1 ]
    Sensitive conduction velocity (SCV)
  • Electrophysiological data analysis : sensitive conduction [ Time Frame: at day 1 ]
    Sensitive distal latency (SDL)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population men or women
Condition
  • CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)
  • CMT (Charcot Marie Tooth Disease)
Intervention 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)
Study Groups/Cohorts
  • 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.
    Intervention: Diagnostic Test: cervical MRI
  • Normal volunteers
    15 healthy subjects matched for age and gender to CIDP patients
    Intervention: Diagnostic Test: cervical MRI
  • 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.
    Intervention: Diagnostic Test: cervical MRI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 8, 2018)
45
Original Actual Enrollment Same as current
Actual Study Completion Date December 31, 2015
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03460951
Other Study ID Numbers CHU-379
2013-A00808-37 ( Other Identifier: 2013-A00808-37 )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Clermont-Ferrand
Study Sponsor University Hospital, Clermont-Ferrand
Collaborators Not Provided
Investigators
Principal Investigator: Frédéric TAITHE University Hospital, Clermont-Ferrand
PRS Account University Hospital, Clermont-Ferrand
Verification Date March 2018