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出境医 / 临床实验 / Diffusion Tensor Imaging of Median Nerve in Diabetic Peripheral Neuropathy
Diffusion Tensor Imaging of Median Nerve in Diabetic Peripheral Neuropathy
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 |
|---|---|
| Diabetic Polyneuropathy Magnetic Resonance Imaging | 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 : | April 30, 2015 |
| Actual Primary Completion Date : | November 30, 2015 |
| Actual Study Completion Date : | November 30, 2015 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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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:
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Healthy Control Subjects
Fifteen normal healthy Egyptian volunteers including10 males and 5 females with a mean age of 45.67±7.77 years.
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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:
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Outcome Measures
Primary Outcome Measures :
- Comparison of diagnostic accuracy of Diffusion tensor imaging in comparison to nerve conduction velocity [ Time Frame: 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.
- Comparison of diagnostic accuracy of Diffusion tensor imaging of peripheral nerves in comparison to motor amplitude in diabetic patients. [ Time Frame: 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.
- Comparison of diagnostic accuracy of Diffusion tensor imaging of peripheral nerves in comparison to sensory amplitude in diabetic patients. [ Time Frame: 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.
- Comparison of diagnostic accuracy of Diffusion tensor imaging of peripheral nerves in comparison to Neuropathy Deficit Score in diabetic patients. [ Time Frame: 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).
- Comparison of diagnostic accuracy of Diffusion tensor imaging of peripheral nerves in comparison to Neuropathy Impairment Score in diabetic patients. [ Time Frame: 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.
- Comparison of diagnostic accuracy of Diffusion tensor imaging of peripheral nerves in comparison to Diabetic Neuropathy Examination in diabetic patients. [ Time Frame: 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 :
- Identifying cut-off value for abnormal diffusion tensor fractional anisotropy in diabetic neuropathy. [ Time Frame: 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.
- Identifying cut-off value for abnormal diffusion tensor apparent diffusion coefficient in diabetic neuropathy. [ Time Frame: 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
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| 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.
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
Contacts and Locations
Locations
| Egypt | |
| Faculty of Medicine, Cairo University | |
| Cairo, Egypt, 11562 | |
Sponsors and Collaborators
Cairo University
Investigators
| Principal Investigator: | Ahmed Abdelalim, MD | Department of Neurology, Cairo University |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | January 26, 2019 | ||||
| First Posted Date | May 2, 2019 | ||||
| Last Update Posted Date | May 3, 2019 | ||||
| Actual Study Start Date | April 30, 2015 | ||||
| Actual Primary Completion Date | November 30, 2015 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
Identifying cut-off scores for abnormal diffusion tensor imaging in diabetic neuropathy. [ Time Frame: Six months ] This study aims to identify cut-off scores of abnormal fractional anisotropy and apparent diffusion coefficient in diabetic neuropathy.
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Diffusion Tensor Imaging of Median Nerve in Diabetic Peripheral Neuropathy | ||||
| Official Title | A Study of Diffusion Tensor Imaging of Median Nerve in Diabetic Peripheral Neuropathy | ||||
| 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 | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. | ||||
| Condition |
|
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| Intervention | 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:
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
45 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | November 30, 2015 | ||||
| Actual Primary Completion Date | November 30, 2015 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| 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 | Egypt | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03934970 | ||||
| Other Study ID Numbers | 19/04/15 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Ahmed Abdelalim, Cairo University | ||||
| Study Sponsor | Cairo University | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Cairo University | ||||
| Verification Date | May 2019 | ||||
