Diffusion Tensor Imaging of Median Nerve in Diabetic Peripheral Neuropathy

NCT ID: NCT03934970

Last Updated: 2019-05-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2015-11-30

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

Conditions

Diabetic Polyneuropathy; Magnetic Resonance Imaging

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Diffusion tensor imaging of peripheral nerves

Intervention Type: DIAGNOSTIC_TEST

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.

Healthy Control Subjects

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

Diffusion tensor imaging of peripheral nerves

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Nerve conduction studies; Neuropathy clinical scores

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abdelalim

Clinial Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Abdelalim, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Cairo University

Locations

Faculty of Medicine, Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

19/04/15

Identifier Type: -

Identifier Source: org_study_id