Dynamic Ultrasound to Enhance Understanding of Carpal Tunnel Syndrome

描述(申请人提供)：腕管综合征(CTS)，是最常见的周围神经病变，但目前还没有生物标志物来帮助指导治疗或预测患者的特定结果。我们推测，在CTS患者中，超声可检测到的神经、肌腱和滑膜下结缔组织(SSCT)活动度的变化可能在临床上作为与治疗反应相关的功能性生物标志物，从而作为治疗反应的预测因子。为了验证这一假设，我们提出了一项临床研究，在这项研究中，在手术和非手术治疗之前和之后，通过超声和临床评估对提出治疗的CTS患者进行监测。我们将把临床结果与我们发现的CTS患者最易变的初始超声运动模式联系起来。我们还将检验这一假设，即成功的治疗会导致受影响的超声变量向正常变化。有4个具体目标。目标1是评估员工的能力 我们已经确定的功能生物标志物(SSCT与肌腱运动的比率、背神经运动以及神经形状随运动的变化)可以预测CTS患者注射类固醇后的结果。目的2是评估我们已经确定的预测CTS患者手术后结果的功能生物标记物的能力。目标3是检验我们的第二个假设，即注射和手术后的治疗反应与受影响的超声变量向正常的变化相关。目标4是使用目标1-3的结果来确定 其他可能与治疗结果相关的生物标记物，并确定任何可能提高CTS治疗后预测结果的能力的临床和生物标记物组合措施。如果这些目标实现，功能性生物标记物将第一次可用于针对特定的CTS患者进行量身定制的治疗。这一新的美国工具可以迅速转化为临床使用，因为这种设备很常见，新的算法可以迅速传播。

DESCRIPTION (provided by applicant): Carpal tunnel syndrome (CTS), is the most common peripheral neuropathy, but currently there are no biomarkers to help guide treatment or to predict patient specific outcomes. We hypothesize that ultrasound detectable variations in nerve, tendon and subsynovial connective tissue (SSCT) mobility in patients with CTS may be useful clinically as functional biomarkers that correlate with, and thereby serve as predictors for treatment response. To test this hypothesis, we propose a clinical study in which patients presenting for treatment of CTS will be monitored by ultrasound and by clinical assessment before and after surgical and non-surgical treatment. We will correlate the clinical outcomes with the initial ultrasound motion patterns that we have found to be most variable in CTS patients. We will also test the hypothesis that successful treatment results in a change towards normal in the affected ultrasound variables. There are 4 Specific Aims. Aim 1 is to assess the ability of the functional biomarkers we have identified (the ratio of SSCT to tendon motion, dorsal nerve motion, and changes in nerve shape with motion) to predict outcome after steroid injection in patients with CTS. Aim 2 is to assess the ability of the functional biomarkers we have identified to predict outcome after surgery in patients with CTS. Aim 3 is to test our secondary hypothesis that treatment response after both injection and surgery correlates with a change towards normal in the affected ultrasound variables. Aim 4 is to, using the results from Aims 1-3, identify additional biomarkers that may correlate with treatment outcome, and to identify any composite clinical and biomarker measures that may improve the ability to predict outcome after treatment for CTS. If these aims are achieved, functional biomarkers will, for the first time, be available t tailor treatment for specific patients with CTS. This new US tool can be rapidly translated into clinical use, since the equipment is commonly available and the new algorithms could be rapidly disseminated.