Diffusion Tensor Imaging in Chronic Inflammatory Demyelinating Polyneuropathy (PIDC)

NCT03460951 | Completed

• 2 other identifiers: CHU-3792013-A00808-37
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy); CMT (Charcot Marie Tooth Disease)

Keywords

Feasibility and reproductibility; DTI parameters (Fractional Anisotropy, Apparent Diffusion Coefficient); MRI morphological parameters (T1, STIR)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

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

  At day 1

• Cervical nerve roots diameter

  at day 1

• Clinical data analysis

  at day 1

• Electrophysiological data analysis : motor conduction

  at day 1

• Electrophysiological data analysis motor conduction

  at day 1

Study Arms (3)

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

Normal volunteers

15 healthy subjects matched for age and gender to CIDP patients

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.

Diagnostic Test: cervical MRI

Interventions

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)

CIDP patients; Charcot-Marie-Tooth disease type 1A patients (CMT-1A); Normal volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

men or women

You may qualify if:

• \- 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Charcot-Marie-Tooth Disease

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Frédéric TAITHE

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: March 9, 2018
• Study Start: November 18, 2013
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: March 9, 2018

Record last verified: 2018-03

Locations

FR (1)