Diffusion Tensor Imaging of Median Nerve in Diabetic Peripheral Neuropathy

A Study of Diffusion Tensor Imaging of Median Nerve in Diabetic Peripheral Neuropathy

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

Study Overview

• Status: Completed
• Conditions: Magnetic Resonance Imaging; Diabetic Polyneuropathy
• Intervention / Treatment: Diagnostic test: Diffusion tensor imaging of peripheral nerves

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Faculty of Medicine, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study is a case-control study of 30 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 years and 15 normal healthy Egyptian volunteers including10 males and 5 females with a mean age of 45.67±7.77 years.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of diagnostic accuracy of Diffusion tensor imaging in comparison to nerve conduction velocity	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.	Six Months
Comparison of diagnostic accuracy of Diffusion tensor imaging of peripheral nerves in comparison to motor amplitude in diabetic patients.	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.	Six Months
Comparison of diagnostic accuracy of Diffusion tensor imaging of peripheral nerves in comparison to sensory amplitude in diabetic patients.	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.	Six Months
Comparison of diagnostic accuracy of Diffusion tensor imaging of peripheral nerves in comparison to Neuropathy Deficit Score in diabetic patients.	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).	Six Months
Comparison of diagnostic accuracy of Diffusion tensor imaging of peripheral nerves in comparison to Neuropathy Impairment Score in diabetic patients.	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.	Six Months
Comparison of diagnostic accuracy of Diffusion tensor imaging of peripheral nerves in comparison to Diabetic Neuropathy Examination in diabetic patients.	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.	Six Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identifying cut-off value for abnormal diffusion tensor fractional anisotropy in diabetic neuropathy.	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.	Six months
Identifying cut-off value for abnormal diffusion tensor apparent diffusion coefficient in diabetic neuropathy.	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.	Six months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 30, 2015
• Primary Completion (ACTUAL): November 30, 2015
• Study Completion (ACTUAL): November 30, 2015

Study Registration Dates

• First Submitted: January 26, 2019
• First Submitted That Met QC Criteria: May 1, 2019
• First Posted (ACTUAL): May 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 3, 2019
• Last Update Submitted That Met QC Criteria: May 1, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Diffusion tensor imaging; Diabetic Polyneuropathy; Neuropathy scores
• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Polyneuropathies; Diabetic Neuropathies
• Other Study ID Numbers: 19/04/15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No