脊髓损伤患者的硬膜外和背根刺激

实验性的：经皮 ES 和 DRS

硬膜外刺激 (ES) 和背根刺激 (DRS) 将在康复期间通过经皮植入的电极进行。 所有植入的电极将在参与试验结束时移除。 ES 和 DRS 的影响将通过结果测量中描述的电生理学和生物力学指标进行记录。

设备：经皮硬膜外和背根刺激

用于背根神经节神经刺激的 Abbott 经皮试验导线（型号 MN10350）

用于硬膜外神经刺激的 Abbott 经皮试验导线（型号 3086）

用于硬膜外和背根神经节神经刺激的雅培临床医生编程器（型号 3874）

Ripple Neuromed Nomad 神经刺激系统

Electromyography

Percent change in EMG voltage from beginning to end of intervention, recorded from the rectus femoris, during epidural and dorsal root spinal stimulation.

Foot Pressure

Measurements of foot pressure from shoe-insole sensors during no-stimulation bilaterally assisted standing and unassisted standing with stimulation.

Somatosensory Evoked Potentials

Change from baseline to end of study, in amplitude of evoked potentials recorded from sensory cortex using skin surface electrodes during electrical stimulation of the right and left tibial nerve.

Transcranial Magnetic Stimulation Motor Evoked Potentials

Change in intensity of stimulation, reported as percentage (0% to 100%) of maximum system output, required to elicit motor-evoked potentials below the level of injury.

American Spinal Injury Association Grading Scale

Severity of spinal cord injury impairment will be assessed at baseline and end of study to examine changes in impairment that may be associated with the intervention.

Spasticity

Change in measurements of spasticity using the Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET). Answers to qualitative questions are rated from -3 to +3, with a higher positive number indicating more helpful symptoms, and a lower negative number indicating more problematic symptoms. Questions may also be answered as not applicable (N/A), which do not generate a score. Scores are totaled for a score which categorizes the overall positive or negative impact of a subject's spasticity symptoms. Total score can range from -105 (negative impact) to +105 (positive impact), and the score is averaged by total positive or negative score divided by the number of applicable answers.

Modified Functional Reach Test

On Day 10 (end of intervention), trunk balance was assessed with and without stimulation during attempts to reach forward using the modified functional reach test.

Patient-reported Bowel Function

Measurement of change in bowel function using the Neurogenic Bowel Dysfunction Score. Answers to qualitative questions are rated from 0 to 5, with a higher number indicating more problematic symptoms, and totaled for a score which categorizes severity of neurogenic bowel symptoms. The total score ranges between 0 and 44 points. A higher total score indicates more severe bowel symptoms.

Patient-reported Bladder Function

Measurement of change in bladder function using the Neurogenic Bladder Symptom Score. Answers to qualitative questions are rated from 0 to 5, with a higher number indicating more problematic symptoms, and totaled for a score which categorizes severity of neurogenic bladder symptoms. The total score can range from 0 (no symptoms at all) to 74 (maximum symptoms).

Male Patient-reported Sexual Function (SHIM)

Measurement of change in erectile dysfunction using the Sexual Health Inventory for Men (SHIM). Answers to qualitative questions are rated from 0 to 5, with a higher number indicating better erectile function, and totaled for a score which categorizes severity of erectile dysfunction. Total score can range from 1 to 25, with a lower number indicating more severe erectile dysfunction.

Male Patient-reported Sexual Function (IEF)

Measurement of change in erectile dysfunction using the International Index for Erectile Function (IIEF). Answers to qualitative questions are rated from 0 to 5, with a higher number indicating better erectile function, and totaled for a score which categorizes severity of erectile dysfunction. Total scores range from 5 to 25, with a lower score indicating more severe erectile dysfunction.

Neurostimulation User Experience

Rating of the subject's perception of individual aspects of spinal stimulation using the User Experience Questionnaire (UEQ), a survey including 26 descriptive terms and their antonyms. A scoring scale ranging from 1 to 7 determines how closely the subject feels the term or its antonym applies to the intervention, with lower numbers indicating agreement with the term, and higher numbers indicating agreement with the antonym. The terms and antonyms describe a positive and negative perception of each item.