Diffusion Tensor Imaging of Median Nerve in Diabetic Peripheral Neuropathy

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT03934970
Collaborator
(none)
45
1
7
6.4

Study Details

Study Description

Brief Summary

This study is a diagnostic accuracy study that aims to evaluate the role of DTI in evaluation of DPN in comparison to clinical scores and nerve conduction studies (NCS). The study included 30 patients with diabetes mellitus complaining of neuropathy symptoms and 15 healthy volunteers. All subjects underwent evaluation using 1.5T DTI of median nerves and NCS. Patients underwent clinical evaluation using Neuropathy Deficit Score (NDS), Neuropathy Impairment Score in the Lower Limbs (NIS-LL) and Diabetic Neuropathy Examination (DNE) score. The values of these tests were compared and correlated and diagnostic accuracy tests were performed together with identification of cut-off score for abnormal diffusion tensor imaging parameters in diabetic neuropathy

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Diffusion tensor imaging of peripheral nerves

Study Design

Study Type:
Observational
Actual Enrollment :
45 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
A Study of Diffusion Tensor Imaging of Median Nerve in Diabetic Peripheral Neuropathy
Actual Study Start Date :
Apr 30, 2015
Actual Primary Completion Date :
Nov 30, 2015
Actual Study Completion Date :
Nov 30, 2015

Arms and Interventions

Arm Intervention/Treatment
Diabetic Neuropathy

Thirty Egyptian patients with type 2 diabetes mellitus complaining of symptoms suggestive of peripheral neuropathy including 12 males and 18 females with a mean of 50.90 ± 9.18.

Diagnostic Test: Diffusion tensor imaging of peripheral nerves
All subjects underwent evaluation using 1.5T DTI of median nerves and NCS. Patients underwent clinical evaluation using Neuropathy Deficit Score (NDS), Neuropathy Impairment Score in the Lower Limbs (NIS-LL) and Diabetic Neuropathy Examination (DNE) score.
Other Names:
  • Nerve conduction studies
  • Neuropathy clinical scores
  • Healthy Control Subjects

    Fifteen normal healthy Egyptian volunteers including10 males and 5 females with a mean age of 45.67±7.77 years.

    Diagnostic Test: Diffusion tensor imaging of peripheral nerves
    All subjects underwent evaluation using 1.5T DTI of median nerves and NCS. Patients underwent clinical evaluation using Neuropathy Deficit Score (NDS), Neuropathy Impairment Score in the Lower Limbs (NIS-LL) and Diabetic Neuropathy Examination (DNE) score.
    Other Names:
  • Nerve conduction studies
  • Neuropathy clinical scores
  • Outcome Measures

    Primary Outcome Measures

    1. Comparison of diagnostic accuracy of Diffusion tensor imaging in comparison to nerve conduction velocity [Six Months]

      This is a diagnostic accuracy study comparing the ability of Diffusion Tensor Imaging to diagnose Diabetic neuropathy. This is performed in comparison to nerve conduction studies which is a well established quantitative and qualitative diagnostic test that measures nerve conduction velocity in meter/second.

    2. Comparison of diagnostic accuracy of Diffusion tensor imaging of peripheral nerves in comparison to motor amplitude in diabetic patients. [Six Months]

      This is a diagnostic accuracy study comparing the ability of Diffusion Tensor Imaging to diagnose Diabetic neuropathy. This is performed in comparison to nerve conduction studies which is a well established quantitative and qualitative diagnostic test that measures motor amplitude in millivolt.

    3. Comparison of diagnostic accuracy of Diffusion tensor imaging of peripheral nerves in comparison to sensory amplitude in diabetic patients. [Six Months]

      This is a diagnostic accuracy study comparing the ability of Diffusion Tensor Imaging to diagnose Diabetic neuropathy. This is performed in comparison to nerve conduction studies which is a well established quantitative and qualitative diagnostic test that measures sensory amplitude in microvolt.

    4. Comparison of diagnostic accuracy of Diffusion tensor imaging of peripheral nerves in comparison to Neuropathy Deficit Score in diabetic patients. [Six Months]

      This is a diagnostic accuracy study comparing the ability of Diffusion Tensor Imaging to diagnose Diabetic neuropathy in comparison to Neuropathy Deficit Score which examines vibration, sensation (0 if present and normal and 1 if absent reduced or uncertain) and ankle reflex (0 if present and normal, and 2 if absent) with a maximum total score of 10. The grades of severity are mild (3-5) moderate (6-8) and severe (9-10).

    5. Comparison of diagnostic accuracy of Diffusion tensor imaging of peripheral nerves in comparison to Neuropathy Impairment Score in diabetic patients. [Six Months]

      This is a diagnostic accuracy study comparing the ability of Diffusion Tensor Imaging to diagnose Diabetic neuropathy in comparison to Neuropathy Impairment Score in the Lower Limbs which evaluates the changes in motor, sensory and reflex activity. The scale ranges from the normal value at "0" points, with a maximum value of 88 points.

    6. Comparison of diagnostic accuracy of Diffusion tensor imaging of peripheral nerves in comparison to Diabetic Neuropathy Examination in diabetic patients. [Six Months]

      This is a diagnostic accuracy study comparing the ability of Diffusion Tensor Imaging to diagnose Diabetic neuropathy in comparison to Diabetic Neuropathy Examination score which tests only the limbs of right side with a maximum score of 16 points. A score, greater than three, is considered abnormal.

    Secondary Outcome Measures

    1. Identifying cut-off value for abnormal diffusion tensor fractional anisotropy in diabetic neuropathy. [Six months]

      This study aims to identify cut-off absolute value of fractional anisotropy that is considered abnormal in diabetic neuropathy. Fractional anisotropy (FA) is a scalar value between zero and one that describes the degree of anisotropy of a diffusion process. A value of zero means that diffusion is isotropic, i.e. it is unrestricted (or equally restricted) in all directions. A value of one means that diffusion occurs only along one axis and is fully restricted along all other directions.

    2. Identifying cut-off value for abnormal diffusion tensor apparent diffusion coefficient in diabetic neuropathy. [Six months]

      This study aims to identify cut-off absolute value of apparent diffusion coefficient (ADC) that is considered abnormal in diabetic neuropathy. An ADC of a tissue is expressed in units of mm2/s. There is no unanimity regarding the boundaries of the range of normal diffusion, but ADC values less than 1.0 to 1.1 x 10-3 mm2/s (or 1000-1100 x 10-6 mm2/s) are generally acknowledged in adults as indicating restriction.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Diabetic patients with symptoms suggestive of peripheral neuropathy.
    Exclusion Criteria:
    • Patients with evidence of nerve entrapment or neuropathy due to causes other than DM

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine, Cairo University Cairo Egypt 11562

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Principal Investigator: Ahmed Abdelalim, MD, Department of Neurology, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Abdelalim, Clinial Professor of Neurology, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03934970
    Other Study ID Numbers:
    • 19/04/15
    First Posted:
    May 2, 2019
    Last Update Posted:
    May 3, 2019
    Last Verified:
    May 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ahmed Abdelalim, Clinial Professor of Neurology, Cairo University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 3, 2019