A Study of Diffusion Tensor Imaging of Median Nerve in Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Comparison of diagnostic accuracy of Diffusion tensor imaging of peripheral nerves in comparison to motor amplitude in diabetic patients.
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diabetic patients with symptoms suggestive of peripheral neuropathy.
排除标准
- •Patients with evidence of nerve entrapment or neuropathy due to causes other than DM
结局指标
主要结局
Comparison of diagnostic accuracy of Diffusion tensor imaging of peripheral nerves in comparison to motor amplitude in diabetic patients.
时间窗: 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.
时间窗: 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.
时间窗: 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 in comparison to nerve conduction velocity
时间窗: 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 Neuropathy Impairment Score in diabetic patients.
时间窗: 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.
时间窗: 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.
次要结局
- Identifying cut-off value for abnormal diffusion tensor apparent diffusion coefficient in diabetic neuropathy.(Six months)
- Identifying cut-off value for abnormal diffusion tensor fractional anisotropy in diabetic neuropathy.(Six months)
研究者
Ahmed Abdelalim
Clinial Professor of Neurology
Cairo University