Pilot Study of Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury

Male patient-reported sexual function (1)

时间窗: Through study completion, an average of 4 weeks

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.

Foot pressure

时间窗: Rehabilitation Day 1, Rehabilitation Day 10

Change in measurements of foot pressure in kilograms through shoe-insole pressure sensors.

Male patient-reported sexual function (2)

时间窗: Through study completion, an average of 4 weeks

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.

Electromyography

时间窗: Rehabilitation Day 1, Rehabilitation Day 10

Change in voltage measurements in major muscle groups below the level of injury.

Electroneurography

时间窗: Rehabilitation Day 1, Rehabilitation Day 10

Change in voltage measurements from passive electrodes in the epidural space of the lumbar spine and dorsal root nerves.

Seated pressure

时间窗: Through study completion, an average of 4 weeks

Change in measurements of foot pressure in kilograms through a force-sensing array placed beneath the buttocks.

Somatosensory evoked potentials

时间窗: Through study completion, an average of 4 weeks

Measurements of change in voltage in the conduction of electricity through the peripheral nerves, cervical and lumbosacral spinal cord, deep brain structures, and sensory cortex, using surface electrodes.

Transcranial magnetic stimulation motor evoked potentials

时间窗: Through study completion, an average of 4 weeks

Measurement of change in voltage required to elicit muscle responses in muscle groups known to elicit optimal motor evoked potential responses, both above and below the level of injury.

Injury severity: American Spinal Injury Association Impairment Scale (AIS)

时间窗: Through study completion, an average of 4 weeks

Change in measurements of impairment of sensory and motor functions using the American Spinal Injury Association Impairment Scale (AISA Scale). Individuals are classified from A" (complete spinal cord injury) to "E" (normal function). 28 dermatomes and 10 key muscles are assessed bilaterally. Results are summed to produce overall sensory and motor scores and are used in combination with evaluation of anal sensory and motor function as a basis for the determination of AIS classification. Sensory scores are rated 0 (sensation absent) to 2 (normal), bilaterally for each of 28 dermatomes. Muscle function is rated 0 (total paralysis) to 5 (active movement, full range of motion against significant resistance) for each myotome. Upper Extremity Motor Subscores and Lower Extremity Motor Subscores are each scored from 0 to 50; the ASIA Motor Score is scored from 0 to 100. The presence of anal sensation and voluntary anal contraction are assessed as a yes/no.

Patient-reported bowel function

时间窗: Through study completion, an average of 4 weeks

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.

Exertion

时间窗: Through study completion, an average of 4 weeks

Measurement of change in the subject's psychophysiological exertion using the Borg Rating of Perceived Exertion. Subjects rate the amount of exertion they are experiencing on a rating scale of 6 to 20, with a higher number indicating more exertion.

Kinematics

时间窗: Rehabilitation Day 1, Rehabilitation Day 10

Change in measurements of joint angles, measured in degrees.

Female patient-reported sexual function

时间窗: Through study completion, an average of 4 weeks

Measurement of change in sexual function using the Female Sexual Function Index (FSFI). Answers to qualitative questions are rated from 0 to 5, with a higher number indicating better sexual function, and totaled for a score which categorizes severity of sexual dysfunction.

Neurostimulation user experience

时间窗: At study completion, an average of 4 weeks

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.

Patient-reported bladder function

时间窗: Through study completion, an average of 4 weeks

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.

Balance (1)

时间窗: Through study completion, an average of 4 weeks

Measurement of changes in basic trunk stability using the Modified Functional Reach Test. Trainers will measure the distance in centimeters the subject can reach forward unsupported without losing trunk stability, with a greater distance indicating greater trunk stability.

Spasticity

时间窗: Through study completion, an average of 4 weeks

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. Scores are totaled for a score which categorizes the overall positive or negative impact of a subject's spasticity symptoms.

Overground ambulation [as appropriate to the subject] (2)

时间窗: Through study completion, an average of 4 weeks

Measurement of changes in overground mobility as measured by the Modified 6 Minute Walk Test. Trainers will assess the distance in meters which the subject can cover in 6 minutes, with a greater distance characterizing better overground mobility.

Overground ambulation [as appropriate to the subject] (1)

时间窗: Through study completion, an average of 4 weeks

Measurement of changes in severity of walking impairment as measured by the Walking Index for Spinal Cord Injury (WISCI II). Trainers combine the type of assistive device(s) used, use or no use of orthotic braces, number of persons assisting ambulation, and distance subject is able to walk (up to 10 meters), into a single score ranging from 0 to 20, with a lower number indicating more severe impairment.

Balance [as appropriate to the subject] (2)

时间窗: Through study completion, an average of 4 weeks

Measurement of changes in ability to perform 14 activities of daily life requiring balance using the Berg Balance Scale. Trainers will assess capabilities in all categories on a 0 to 4 scale, with a higher number indicating greater capability, and total the scores, with a higher total score indicating greater overall balance.

Electromyography

时间窗: Assessed at Day 1 (beginning of intervention) and Day 10 (end of intervention).

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

时间窗: Assessed at Day 10 (end of intervention).

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

Somatosensory Evoked Potentials

时间窗: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).

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

时间窗: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).

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

时间窗: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).

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

时间窗: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).

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

时间窗: Assessed at Day 10 (end of intervention).

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.